clinical research job cover letter sample

Clinical Research Associate Cover Letter Examples

Use these Clinical Research Associate cover letter examples to help you write a powerful cover letter that will separate you from the competition.

Clinical research associates (CRAs) are responsible for conducting clinical research trials. They work with doctors, nurses, and other medical professionals to make sure trials are conducted safely and accurately.

To be a successful CRA, you need to be detail-oriented, organized, and able to work under pressure. In your cover letter, you need to highlight your skills and experience that make you the perfect candidate for the job.

Use these examples to write a clinical research associate cover letter that will help you get the job.

Formal/Professional Writing Style Example

With a strong background in clinical research and a genuine passion for contributing to the advancement of medical science, I am confident in my ability to excel in the role of Clinical Research Associate.

I hold a Bachelor’s degree in Biological Sciences and have accumulated over three years of experience working in dynamic clinical research environments, including my current role as a Clinical Research Coordinator with XYZ Pharmaceuticals. Through this experience, I have honed my skills in conducting clinical trials, managing data collection, ensuring compliance with regulations, and collaborating with multidisciplinary teams. My ability to analyze trial data and provide effective solutions for challenges faced during the research process has resulted in a track record of successful project completion and advancements in clinical knowledge.

In addition to my technical acumen, I possess strong communication and organizational skills which have been essential in coordinating projects, serving as a liaison between my team and external stakeholders, and presenting research findings to diverse audiences. I am proficient in multiple clinical trial management systems and have extensive knowledge of regulatory guidelines including ICH GCP, FDA, and EMA requirements.

As a highly motivated and detail-oriented individual, I am eager to contribute to your organization’s success by applying my skills and expertise in clinical research. I am excited about the opportunity to work with your team of professionals and am confident that my qualifications align with your expectations for the Clinical Research Associate position.

Thank you for considering my application. I look forward to the opportunity to further discuss my suitability for this role in an interview.

[Your Name]

Entry-Level Writing Style Example

As a recent graduate with a Bachelor of Science in Biology from XYZ University, I am eager to embark on a career in clinical research and believe my strong academic foundation and passion for improving healthcare outcomes make me a valuable candidate for this role.

Throughout my academic career, I cultivated a solid understanding of clinical research processes and refined my analytical and problem-solving skills. My coursework in Molecular Biology, Biostatistics, and Bioethics provided me with the technical knowledge essential for this position. Additionally, I gained hands-on experience while interning at ABC Research Institute, where I played an integral role in coordinating a pilot study that evaluated the efficacy of a novel treatment for diabetes. This experience not only exposed me to the intricacies of clinical trials but also allowed me to practice effective communication and collaboration skills critical to working in this field.

As an entry-level candidate, I am highly motivated to equip myself with the skills and experiences necessary to contribute meaningfully to your organization’s clinical research efforts. I am confident in my ability to learn quickly and adapt to new situations, and I am excited about the potential opportunity to become a Clinical Research Associate at your esteemed company.

I hope to have the opportunity to discuss my qualifications further during an interview. Thank you very much for considering my application.

Networking/Referral Writing Style Example

I recently had the pleasure of speaking with Dr. Jane Smith, who is a Senior Researcher in your team, about the opportunity, and she highly recommended that I apply, based on my background and skills. Dr. Smith and I worked together for over two years at XYZ Research Institute, where we collaborated on several successful research projects. She mentioned that your company is looking for a professional who is skilled in clinical research and has experience working in a fast-paced, dynamic environment, which perfectly aligns with my experience and expertise.

During my 5-year career in clinical research, I have gained invaluable experience in study design, data collection, and analysis, as well as extensive knowledge of Good Clinical Practice (GCP) and regulatory requirements. In my previous role as a Clinical Research Coordinator at ABC Pharmaceuticals, I was praised for my excellent communication skills, attention to detail, and my ability to adapt to new technologies quickly. My experience working with Dr. Smith and the aforementioned qualities make me a strong fit for this role.

I am excited about the prospect of furthering my career with your prestigious company and confident that my experience and passion for clinical research will allow me to make a substantial contribution to your team. I have attached my resume for your review, and I am eager to discuss my suitability for this position further.

Thank you for considering my application. I am looking forward to the opportunity to speak with you soon.

Enthusiastic/Passionate Writing Style Example

As someone deeply committed to contributing to the progress of medical science, I cannot imagine a more fulfilling position for me than being a driving force behind clinical research that has the potential to save lives and improve countless others. Having followed your organization’s groundbreaking studies for some time, I am not only impressed by the scientific achievements but also inspired by your commitment to safety, quality, and patient-centered approaches in clinical research.

My background in clinical research has equipped me with a strong foundation in study design, data analysis, and regulatory compliance. In my previous role as a Clinical Research Coordinator, I prided myself on being highly organized, diligent, and detail-oriented while working on multiple trials simultaneously. My passion in this field is fueled by the direct impact that clinical research has on both individual patients and entire populations.

Now, I eagerly look forward to the opportunity to join your esteemed organization and contribute first-hand to the advancement of life-changing research. I believe that my highly motivated work ethic, technical expertise, and genuine passion for clinical research would make me an exemplary Clinical Research Associate at your company.

Thank you for considering my application. I am excited about the prospect of being a part of your dedicated team and would be thrilled to discuss my experience and qualifications further. I am confident that my heart and soul, backed by my knowledge and skills, will make a meaningful difference at your organization.

Looking forward to the opportunity to contribute to the success of your company.

Problem-Solving Writing Style Example

Having done extensive research on your company, I understand that you are at the forefront of developing cutting-edge therapies for various medical conditions. With the rapid growth of the clinical research industry, it is evident that there is a pressing need for skilled associates who can drive research initiatives and provide innovative solutions to the challenges faced in clinical trials.

As a highly motivated and experienced Clinical Research Associate, I strongly believe that my skills and expertise can contribute to addressing these challenges and help shape the future of medical advancements at your organization.

My experience in clinical research has allowed me to gain a strong understanding of the complexities encountered in various phases of clinical trials. Having managed numerous multi-center studies, I have experienced first-hand the difficulties in ensuring data integrity, patient safety and compliance with regulations. These experiences have honed my problem-solving skills and ability to adapt to difficult situations, enabling me to swiftly identify and provide effective solutions.

In my most recent role, I took the initiative to develop and implement an innovative site-monitoring plan that led to a significant reduction in data discrepancies and improved patient safety. I am excited to bring this proactive approach to your organization and collaborate with your talented team to drive clinical trial efficiency, ensure compliance, and ultimately contribute to the development of breakthrough therapies.

I am truly passionate about clinical research and its potential to improve the lives of countless individuals worldwide. I would be honored to bring my expertise, dedication and drive to your organization as a Clinical Research Associate.

Thank you for considering my application. I eagerly look forward to the opportunity to discuss my fit for this role and learn more about the impactful work being done at your company.

Storytelling/Narrative Writing Style Example

I fondly remember the day I first stepped into a clinical research lab during my undergraduate studies. The excitement in the air was palpable, and I was instantly drawn to the world of research. It was during my time assisting in a study on the effects of a novel cancer treatment that I knew my future lay in clinical research. With that passion driving me, I pursued my Master’s degree in Clinical Research and have since been fortunate enough to gain valuable experience in the field.

Just last year, I was part of a dedicated team working on a clinical trial for an innovative Alzheimer’s drug. I vividly recall the day we received a letter from a participant’s family, thanking us for our work and sharing that their loved one seemed more present and engaged. That moment made me realize the profound impact our work can have on people’s lives, and I am eager to contribute to meaningful research at your organization.

As a Clinical Research Associate, I have developed strong skills in study protocol design, data collection, and statistical analysis. My ability to work effectively in a team and my keen attention to detail have been key factors in the success of previous projects. Furthermore, I am well-versed in regulatory requirements and Good Clinical Practice guidelines, ensuring that all research activities are conducted ethically and efficiently.

I am confident that my passion for clinical research, combined with my relevant experience and skills, would make me an asset to your organization. I am eager to contribute to the groundbreaking work being done at your institution and help improve the lives of patients. Thank you for considering my application. I look forward to the opportunity to discuss my candidacy further.

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• Clinical Research Coordinator

Clinical Research Coordinator cover letter example

When hiring a clinical research coordinator, HR personnel look for someone who understands how to conduct scientific studies and maintain standards at all times. A clinical research coordinator cover letter must impress upon the hiring manager that the candidate focuses on the details of the clinical trial while managing all that it entails.

While resumes give a broad overview of all that you have accomplished in your career, it is within your cover letter that you can express your views on clinical studies, how you work with the principal investigator to ensure the integrity of the trial, and your style in collaborating with the entire research team, the participants, and any other stakeholders.

It’s true that not every employer will read your cover letter, but the extra effort you put into it will make a difference with those employers who do read it, so, yes, you need a cover letter. 

This one-page letter may seem a bit daunting when you are staring at a blank screen, the writing guide below will take the mystery out of the process. 

When you are finished reading the writing guide and corresponding clinical research coordinator cover letter example, you will know:

• Why cover letters are important parts of your application package
• How best to approach composing an effective cover letter
• The components of a cover letter (introduction, middle part, and closing) and what goes into them
• Common mistakes to avoid in a clinical research coordinator cover letter

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Best format for a clinical research coordinator cover letter

Research requires precision, process, and consistency. You wouldn’t begin a medical trial without creating methods for ensuring those three aspects of the trial are in place. The  formatting of your clinical research coordinator cover letter gives you a framework for creating those components in your application document. Before you jump into writing, you need to know what goes into your letter.

The format of a clinical research coordinator cover letter should contain the following elements:

• The cover letter header
• The greeting/salutation
• The cover letter intro
• The middle paragraphs (body of the letter)
• The ending paragraph of your cover letter (conclusion and call-to-action)

For a general overview of writing cover letters, turn to the comprehensive cover letter guide, but below you will find specific advice on how to maximize the effectiveness of each specific letter paragraph and section. 

This clinical research coordinator cover letter example will give you a blueprint for writing your own cover letter:

Dear Professor Varane,

With a Bachelor of Science in Biology and over five years of experience coordinating clinical research in academic and pharmaceutical environments, I believe my expertise makes me a perfect fit for the clinical research coordinator role.

At Pines, I was responsible for managing a variety of clinical trials across different therapeutic areas, such as oncology, neurology, and cardiology. I have personally overseen the successful completion of 24 clinical studies and was instrumental in recruiting over 600 patients, with a 90% enrollment rate. 

I enjoy working with clinicians, principal investigators, data managers, and laboratory staff in cross-functional teams. It is important to streamline processes and ensure that everyone is synchronized in their work. I undertook a project at my previous employer which increased the efficacy of data collection by 25%. I have participated in several research projects that have combined data science with AI analysis and hope to develop my skills more in this area.

On the administration side, I have a proven track record in preparing and submitting regulatory documentation, such as Investigational New Drug (IND) applications and Institutional Review Board (IRB) approvals. My meticulous attention to detail and regulatory compliance contributed to zero findings during a recent FDA audit. 

I was alerted to the role by your colleague Sarah Hatton, having worked with her previously at Pines. She felt that my methodical approach would fit in well with the Lansley team. I hope to have the opportunity of an interview to find out more about the potential fit.

Christian Root

Cover letter header

A standard letter does not provide any visual interest, but an application letter does. Your clinical research coordinator cover letter has a header that provides an opportunity for a bit of creativity, but with the caveat that the most important aspect is clear, legible contact information.

Clinical research is serious, scientific work, so you should choose a header design that conveys organization and professionalism. Coordinate this style with the one you choose for your resume. (Our cover letter templates have corresponding resume layouts.)

Your header should contain your name, title, LinkedIn or other professional social media accounts, and the best email and phone number with which to contact you.

Cover letter greeting

The greeting of your clinical research coordinator cover letter is your textual first impression. While you want to use the hiring manager’s name ( addressing people by name creates a feeling of respect and recognition), you also want to stick with their title and last name.

When making professional contact, stay businesslike. Your best bet is “Dear Dr./Mr./Ms./Mx. [surname]. In your profession, it is likely that the principal investigator has a doctorate or a medical degree. Make sure you get their title and the spelling of their name correct. In a detail-oriented career such as yours, you cannot afford to get the details wrong.

A simple call to the lab or company may net you the correct person to address if the job listing lacks a contact person. Otherwise, you may use “Dear Research Team,” or “Dear Science Department.” Do not fall back on the stilted and outdated “To Whom It May Concern.”

The aim of the cover letter greeting: engage your reader by addressing them personally, but professionally.

Cover letter introduction

Just as it sounds, the introduction gives an overview of who you are in experience and temperament. It also sets the tone for the remainder of your document. A clinical coordinator cover letter should sound professional, but that does not mean resorting to a lot of jargon. 

Start off with a sentence about your experience working on clinical research and your area(s) of expertise. The purpose of your entire document is to make a case for your employment, so make sure you include your thesis sentence here. You will spend the rest of your letter offering evidence to support your reason.

The introduction should also state why you want this position. It’s not simply that you want to be a clinical research coordinator, but you want to work in this specific environment, for this lab or company, on this type of research. This, of course, means that you must rework your cover letter for each different position.

The purpose of the introduction: hook the reader with your most impressive career highlight and explain your interest in the position.

Who are clinical research coordinators?*

• First-time coordinators usually have a bachelor’s degree and five years of research experience
• More than 80 percent of clinical research coordinators are women
• The mean annual salary is $137,900
• People with the following qualities are attracted to clinical research coordinator positions: cooperative, dependable detail-oriented, having integrity and self-control, and self-motivation.

*Source: My Next Move

Cover letter middle part (body)

The middle part of your clinical coordinator cover letter expands upon your introduction by adding evidence of your skills and knowledge. If you’ve already compiled your resume but needed more room to fully explain one or two of your bullet points, this is the place to do it.

Choose one clinical trial you coordinated or worked on if you are looking for a promotion. Take a few sentences to describe it and your role in its success. As a coordinator, you are responsible for many moving pieces and must ensure that all protocols are followed to the letter. Any missed steps could negate the entire study, so be sure to explain your organizational structure.

Try to anticipate interview questions and answer them at this stage. Here are a few you may consider answering in the body of your letter:

• What is the most important quality of a clinical coordinator?
• Why do you want to work in this particular area of research?
• How do you ensure compliance with all regulations during a clinical trial?
• Describe your collaboration style.
• How do you explain risk and ensure trial participants understand all aspects of the study?

You may have space to answer only one of these questions, or you may choose to focus on summarizing and highlighting your successes instead, but be aware that some of these questions will come up if you are granted an interview.

Because a cover letter is text heavy, it is a good idea to use a bulleted list within the body. There’s no need to cut and paste from your resume. Instead, you may describe a trial and then use bulleted items to briefly mention the aspects of the trial you coordinated or to enumerate the findings of the study and your role in those findings.

The goal of the middle part: Stack the evidence in your favor by detailing the successful trials you have worked on.

How to close a clinical research coordinator cover letter (conclusion and sign-off)

Your reader has made it this far – great! It’s time to remind them of why they were intrigued. Use the ending of your clinical research coordinator cover letter to reframe your main point and let them know without a doubt that you want to discuss the opportunity further.

If you have space, you may reveal a personal detail, such as a connection to the type of research you are applying to coordinate, but keep it professional. Your call to action, or request for an interview, should be positive without making assumptions.

The aim of the conclusion: remind your reader of your key point and request an interview.

Basic mistakes in a clinical research coordinator application letter (and how to avoid them)

• Shifting or inappropriate tone. Maintain a consistently professional tone throughout your letter. You will be communicating with trial participants and you need to demonstrate that you can be authoritative, yet friendly when you explain the potential risks and answer their questions.
• Errors. Simply put, any mistake in your clinical coordinator cover letter is unacceptable. Clinical trials cannot afford errors (although everyone makes a small one every now and then), so proofread and use spelling and grammar tools to avoid this pitfall.
• Neglecting to personalize your letter. Every job is different and employers will have different priorities and needs. You need to do more than change the name in your greeting if you want to demonstrate that you understand your prospective employer’s needs and know how to fill them.
• Being too modest or too confident. Find the balance between taking too much credit for success and not acknowledging your strengths. Give others credit where it is due. It is fine to say that you achieved success with your team. In fact, the ability to work in a team is a sought-after skill.

Key takeaways

• A great cover letter offers employers details about your personality and career that don’t fit into the tight format of a resume.
• Clinical research coordinators work closely on the day-to-day functioning of research trials and must adhere to strict regulations.
• A friendly greeting that addresses a person by name is the best way to start your cover letter but keep your tone professional throughout.
• Use the middle part of your application letter to head off one or two potential interview questions, or go into detail about a clinical trial you worked on.
• Make sure the hiring manager knows you’re interested by requesting an interview.

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Clinical Researcher Cover Letter Example

Writing a cover letter for a job as a Clinical Researcher can be a challenging task. There are several key elements to consider in order to create a strong, compelling letter that will help you stand out from other applicants. This guide provides advice and tips for writing an effective cover letter for a Clinical Researcher position, along with an example of a successful cover letter to help you get started. With the right preparation and writing approach, you can make the most of your cover letter and increase your chances of landing a job.

If you didn’t find what you were looking for, be sure to check out our complete library of cover letter examples .

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Clinical Researcher Cover Letter Sample

Dear [Hiring Manager],

My name is [Name], and I am writing to apply for the role of Clinical Researcher at [Company Name]. I am a highly experienced clinician and research scientist with a proven track record of delivering successful clinical studies and trials.

My extensive research experience includes working on clinical studies and trials for the [organization], where I was responsible for leading a team of researchers and coordinating the collection and analysis of data. I have extensive experience in both large- scale studies and smaller, targeted trials, and have a strong background in using advanced research methods, such as quantitative and qualitative analysis.

In addition to my diverse research experience, I have a master’s degree in [Field] and have completed several courses in clinical research and data analysis. I have a strong understanding of regulatory guidelines and ethical principles, and I am well- versed in the requirements and standards set by the FDA.

I am confident that I can bring a wealth of knowledge and experience in clinical research to the role of Clinical Researcher at [Company Name], and I am excited about the prospect of contributing to the growth of your research program. I am available for a phone or video interview at your convenience, and I look forward to discussing this opportunity with you further.

Thank you for your time and consideration.

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What should a Clinical Researcher cover letter include?

A Clinical Researcher cover letter should include a professional introduction that immediately captures the attention of the hiring manager. It should also include some information about yourself and your qualifications. Your cover letter should emphasize your experience and qualifications related to the position you are applying for. Additionally, you should clearly communicate why you are the right candidate for the job.

When crafting your Clinical Researcher cover letter, it is also important to give specific examples of skills, accomplishments, or experience that make you the ideal candidate. For example, you may want to mention your ability to effectively collaborate with other researchers, analyze patient data, and produce high- quality research reports. It is also beneficial to provide examples of how your research has had an impact on the medical field.

Finally, your Clinical Researcher cover letter should include a brief summary that reiterates why you are the best candidate for the job. Your conclusion should be concise and to the point, leaving the reader with a strong impression of your skills and qualifications.

Clinical Researcher Cover Letter Writing Tips

Are you interested in becoming a clinical researcher? If you are, then you’ll want to make sure your cover letter is as impressive as possible. Applying for a job as a clinical researcher requires a professional and well- written cover letter to capture the attention of the hiring manager. Here are some tips to help you write an outstanding clinical researcher cover letter:

• Present yourself professionally: Make sure your cover letter reflects your professional background and qualifications. Use formal language and avoid any errors in grammar, punctuation, or spelling.
• Clearly explain your experience: Provide a clear and concise description of your experience. Make sure you include any relevant information regarding your past work experience, education, or any additional qualifications.
• Show your enthusiasm: Demonstrate your enthusiasm for the position by discussing why you’re interested in the job, what skills and qualities you possess that are beneficial for the role, and why you believe you’d be a great fit for the position.
• Provide details: Make sure to include specifics about your qualifications and experience, such as clinical research projects you’ve completed or any awards or certifications you’ve earned.
• Demonstrate your knowledge: Show the hiring manager that you understand the requirements of the job, by providing an overview of the research processes and protocols you’re familiar with.
• Proofread your letter: Before sending your letter, proofread it several times to ensure there are no errors. Have someone else look it over to make sure it’s free of any typos or mistakes.

By following these tips, you’ll be able to create an impressive and professional cover letter that will help you to stand out from the competition. Good luck with your job search!

Common mistakes to avoid when writing Clinical Researcher Cover letter

Writing a cover letter for a clinical researcher role requires attention to detail and careful consideration to ensure it is professional and highlights your relevant skills. To ensure your cover letter stands out from the competition, here are some common mistakes to avoid while writing your clinical researcher cover letter:

• Not Tailoring to the Role: It’s important to tailor your letter to the specific role you are applying for; it should reflect the qualifications and skills listed in the job description. Generic cover letters that don’t mention the role or use generic language will not grab the attention of the recruiter.
• Not Being Concise: It is important to be concise when writing your cover letter, keeping it to no more than one page. You need to be able to explain your experience and qualifications quickly and clearly, without waffling on.
• Not Demonstrating Your Knowledge: Show the recruiter that you know about the company and the role you’re applying for. Demonstrate that you have done your research and that you’re knowledgeable about the subject area.
• Not Proofreading: Before sending your cover letter, it’s essential to proofread it thoroughly to ensure there are no spelling or grammar errors. It’s also important to make sure you’ve used the correct terminology and that the information is accurate.
• Not Including a Call to Action: Include a call to action at the end of your letter, such as asking to set up an interview. This will show the recruiter you are keen to secure the role and will help move the process forward.

Following these tips should help you create a successful cover letter for a clinical researcher role. Ensure your cover letter is tailored to the role, concise, and contains a call to action for the best chance of success.

Key takeaways

Writing a cover letter for a clinical researcher position is an important part of the job application process. It is your chance to introduce yourself to the hiring manager and demonstrate your passion, qualifications, and experience for the job.

Here are some key takeaways when writing a clinical researcher cover letter:

• Highlight your research experience and achievements: Showcase the research projects you have worked on and the results you have achieved.
• Showcase your technical skills: Clinical researchers must have strong technical skills. Explain the technical skills you have and how you have used them in the past to complete research projects.
• Describe your knowledge of the field: Demonstrate your knowledge of the field by discussing the latest developments, publications, and research in the field.
• Explain the value you can bring to the position: Explain how you can contribute to the research objectives of the organization and how you can help them achieve their goals.
• Use the right language: Use the right language when writing your cover letter. Use clear, concise language and avoid jargon or technical terms.
• Follow the standard format: Keep your cover letter professional and concise. Follow the standard format of a cover letter, including the introduction, body, and conclusion.

Following these key takeaways when writing a cover letter for a clinical researcher position will give you the best chance of successfully landing the job. Make sure you highlight your research experience, technical skills, knowledge of the field, and value you can bring to the position. Use the right language and follow the standard format for the best results.

Frequently Asked Questions

1.how do i write a cover letter for an clinical researcher job with no experience.

Writing a cover letter for an Clinical Researcher job with no experience can be a daunting task. However, if you take the time to prepare, you can stand out from the competition and make a strong impression on potential employers.

Start by researching the position and the hiring manager’s expectations, so that you can tailor your cover letter to their needs. Include a strong opening paragraph that summarizes your relevant qualifications and highlights the value you can bring to the company. Showcase your research, critical thinking and problem- solving skills, and be sure to emphasize any relevant coursework or internships. Explain how your unique combination of experience, education and personal qualities will help you excel in the role.

Finally, express your enthusiasm for the position and thank the hiring manager for taking the time to review your application.

2.How do I write a cover letter for an Clinical Researcher job experience?

When applying for an Clinical Researcher job with experience, an effective cover letter can make all the difference. Start by referencing your relevant professional experience and the skills you developed during your career. Then, highlight any research or clinical experience you have, as well as any specialized training or certifications.

Be sure to emphasize the accomplishments you have achieved in previous roles and explain how they relate to the position you are applying for. Showcase your critical thinking and problem- solving skills, and be sure to demonstrate your enthusiasm for the role. Finally, thank the hiring manager for taking the time to review your application and express your interest in the position.

3.How can I highlight my accomplishments in Clinical Researcher cover letter?

When highlighting your accomplishments in a Clinical Researcher cover letter, it’s important to focus on the skills and experience that make you a strong candidate for the position. Showcase any research or clinical experience you have, as well as any specialized training or certifications. Explain how your knowledge, skills and abilities were used to resolve issues and develop solutions.

Provide specific examples of how your work has made an impact on the organization, such as improving patient outcomes or developing new processes. Finally, be sure to emphasize any awards or recognitions you have received in the past.

4.What is a good cover letter for an Clinical Researcher job?

A good cover letter for an Clinical Researcher job should demonstrate your enthusiasm for the position and highlight the skills and experience that make you a strong candidate. Start by referencing your relevant professional experience and the skills you developed during your career.

Be sure to explain how your unique combination of experience, education and personal qualities will help you excel in the role. Showcase any research or clinical experience you have, as well as any specialized training or certifications.

In addition to this, be sure to check out our cover letter templates , cover letter formats ,  cover letter examples ,  job description , and  career advice  pages for more helpful tips and advice.

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7 Clinical Research Coordinator Cover Letter Examples

Introduction.

In today's competitive job market, a well-tailored cover letter can make all the difference when it comes to landing your dream job as a clinical research coordinator. As a crucial component of your job application, a cover letter allows you to showcase your skills, experience, and passion for the field. It provides a unique opportunity to highlight your suitability for the role and capture the attention of hiring managers.

A well-crafted cover letter can help you stand out from the crowd and demonstrate your commitment to excellence in clinical research coordination. In this article, we will provide you with a collection of clinical research coordinator cover letter examples to inspire and guide you as you craft your own personalized cover letter. These examples will cover a range of scenarios and highlight different aspects of the role, giving you valuable insights into what makes a cover letter effective in this field.

Whether you are a seasoned clinical research coordinator looking to take the next step in your career or a recent graduate eager to make your mark in the industry, these cover letter examples will help you present yourself as the ideal candidate for the job. So let's dive in and explore the key elements of a strong clinical research coordinator cover letter!

Example 1: Entry-Level Clinical Research Coordinator Cover Letter

Key takeaways.

Sarah's cover letter effectively highlights her relevant education and experience, positioning her as a strong candidate for the entry-level Clinical Research Coordinator position at the National Institute of Health.

When applying for an entry-level position, it is crucial to showcase any relevant education and experience that demonstrates your ability to handle the responsibilities of the role. This helps the hiring manager see your potential as a valuable asset to the organization.

Sarah emphasizes her practical experience as a Research Assistant at Johns Hopkins Medicine, where she gained hands-on experience in data collection, analysis, and documentation. This showcases her attention to detail and organizational skills, which are essential for a Clinical Research Coordinator.

Highlighting specific tasks and responsibilities from previous roles can help demonstrate your ability to handle similar responsibilities in the target position. This shows the hiring manager that you have the necessary skills and experience to excel in the role.

She also mentions her volunteer experience as a Research Coordinator at the American Cancer Society, emphasizing her ability to coordinate patient enrollment and ensure compliance with research protocols. This demonstrates her communication and interpersonal skills, which are crucial for working effectively with patients and healthcare professionals.

Don't overlook volunteer or extracurricular experiences that are relevant to the position. These experiences can provide valuable insights into your abilities and dedication, especially for entry-level roles.

Sarah's cover letter could be further improved by highlighting any specific achievements or notable contributions she made during her previous roles, such as successfully completing a research project or implementing improvements to a research process.

Whenever possible, include specific achievements or contributions that highlight your impact and value. This helps differentiate you from other candidates and showcases your ability to deliver results.

Example 2: Senior Clinical Research Coordinator Cover Letter

Michael's cover letter effectively showcases his extensive experience and expertise in clinical research coordination, positioning him as an ideal candidate for the Senior Clinical Research Coordinator position at Mayo Clinic.

When applying for a senior-level position, it's crucial to highlight your relevant work history and accomplishments. This demonstrates your ability to handle complex research projects and lead teams effectively.

He emphasizes his experience in managing multiple research projects, ensuring adherence to protocols and timelines, which demonstrates his strong organizational skills and attention to detail.

Highlighting your ability to manage multiple projects and maintain strict adherence to protocols showcases your ability to handle the demands of a senior clinical research coordinator role.

Michael also highlights his experience in mentoring junior team members and developing standard operating procedures to improve efficiency and streamline processes, which indicates his leadership skills and commitment to continuous improvement.

Demonstrating your leadership abilities and commitment to process improvement can set you apart as a candidate for a senior-level position. Highlight any experience you have in mentoring, training, or implementing process enhancements.

Overall, Michael's cover letter effectively conveys his qualifications, experience, and passion for clinical research coordination, making him a strong candidate for the Senior Clinical Research Coordinator position at Mayo Clinic.

Example 3: Oncology Clinical Research Coordinator Cover Letter

Emily's cover letter effectively showcases her extensive experience and expertise in oncology research and clinical coordination. Her specific examples highlight her ability to manage complex clinical trials and collaborate effectively with various stakeholders.

When applying for a specialized role like an Oncology Clinical Research Coordinator, it's crucial to highlight your specific experience and qualifications in the field. This demonstrates your in-depth understanding of the unique challenges and requirements of oncology research.

Emily emphasizes her success in patient recruitment and retention, as well as her attention to detail in maintaining accurate records and ensuring compliance with study protocols.

In clinical research coordination, attention to detail and adherence to protocols are crucial. Highlighting your ability to effectively manage these aspects demonstrates your commitment to maintaining high-quality data and ethical research practices.

She also mentions her experience in coordinating multi-center clinical trials, showcasing her ability to collaborate with diverse teams and manage complex logistics.

The ability to coordinate multi-center trials is highly valued in the field of oncology research. Highlighting your experience in this area demonstrates your ability to work effectively with multiple stakeholders and navigate the challenges of conducting research across different institutions.

To further strengthen her cover letter, Emily could mention specific achievements or outcomes from her previous research projects to highlight the impact of her work.

Including specific achievements or outcomes from your previous research projects can provide concrete evidence of your contributions and demonstrate the value you can bring to MD Anderson Cancer Center.

Example 4: Pediatric Clinical Research Coordinator Cover Letter

Samantha's cover letter effectively highlights her extensive experience in pediatric clinical research, positioning her as an ideal candidate for the Pediatric Clinical Research Coordinator position at Children's Hospital of Philadelphia.

When applying for a niche role like Pediatric Clinical Research Coordinator, it is crucial to emphasize your specific experience and expertise in the field. This demonstrates your understanding of the unique challenges and requirements of the role.

She showcases her practical skills in study coordination, data analysis, and regulatory compliance, emphasizing her ability to handle the complexities of pediatric clinical research.

Highlighting your technical skills and knowledge of research methodologies is essential in a cover letter for a clinical research position. This demonstrates your proficiency in executing research protocols and analyzing data accurately.

Samantha also emphasizes her compassionate approach and ability to build rapport with patients and their families, which is crucial in a pediatric setting.

In a field focused on pediatric medicine, showcasing your ability to work with children and families is essential. Highlight your empathy, communication skills, and ability to create a supportive environment for study participants.

To further strengthen her cover letter, Samantha could have provided specific examples of successful research projects she has contributed to, including any notable publications or achievements.

Including specific examples of your contributions to research projects can provide tangible evidence of your impact and demonstrate your ability to contribute to the advancement of pediatric medicine at the institution you are applying to.

Example 5: Behavioral Clinical Research Coordinator Cover Letter

Rachel's cover letter effectively showcases her qualifications and experience as a Behavioral Clinical Research Coordinator, positioning her as an ideal candidate for the position at Stanford University School of Medicine.

When applying for a specialized research coordinator role, it's crucial to emphasize your experience and accomplishments in the specific field of research. This demonstrates your expertise and your ability to contribute to the organization's research goals.

She highlights her role as a Behavioral Clinical Research Coordinator at the University of Pennsylvania and describes her responsibilities, including developing study protocols, recruiting participants, and analyzing data. Rachel also emphasizes her accomplishment of leading a study that resulted in the development of a highly effective behavioral intervention for individuals with anxiety disorders.

Highlighting specific achievements and successful research projects helps to demonstrate your impact and the value you bring to the field. This can set you apart from other applicants and show your ability to contribute to groundbreaking research.

Rachel expresses her interest in Stanford University School of Medicine and its reputation for excellence in research and advancement of scientific knowledge in the field of behavioral health. This demonstrates her enthusiasm for the organization and her alignment with its mission and values.

When applying to a prestigious institution known for its research, it's essential to convey your genuine interest and enthusiasm for the organization. This shows that you are motivated and committed to contributing to their research endeavors.

Example 6: Contract Clinical Research Coordinator Cover Letter

Kevin's cover letter effectively highlights his experience and skills as a Clinical Research Coordinator, positioning him as an ideal candidate for the Contract Clinical Research Coordinator position at PRA Health Sciences.

When applying for a specific role, it's crucial to showcase your relevant experience and expertise that directly align with the job requirements. This demonstrates your ability to hit the ground running and contribute immediately.

Kevin emphasizes his experience in managing clinical trials from start to finish, showcasing his ability to handle the complexities of coordinating complex trials.

Highlight your experience in managing various aspects of clinical trials, such as protocol adherence, data collection, and analysis. This demonstrates your attention to detail, analytical skills, and ability to navigate regulatory requirements.

He also highlights his strong organizational skills and ability to multitask effectively, which are essential qualities for a Clinical Research Coordinator.

Emphasize your organizational skills and ability to manage multiple trials simultaneously. This showcases your ability to handle competing priorities and ensure the smooth execution of studies.

Kevin expresses his genuine interest in PRA Health Sciences and aligns his skills and experience with the company's mission and values.

Research the company you're applying to and highlight specific aspects that resonate with you. This shows your enthusiasm and dedication to contributing to the organization's success.

Example 7: Remote Clinical Research Coordinator Cover Letter

Maria's cover letter effectively showcases her experience and expertise as a Clinical Research Coordinator, positioning her as an ideal candidate for the Remote Clinical Research Coordinator position at Medpace.

When applying for a specific role, emphasize your relevant experience and skills that align with the company's requirements. This demonstrates your understanding of the role and your ability to contribute effectively.

She highlights her experience in managing multiple clinical trials, ensuring compliance with regulatory requirements, and maintaining accurate documentation. These accomplishments demonstrate her attention to detail and organizational skills, which are crucial for a Clinical Research Coordinator.

Highlight specific achievements and responsibilities that are directly relevant to the role you are applying for. This helps the hiring manager understand your capabilities and the value you can bring to the organization.

Maria also emphasizes her experience in remote clinical research coordination, showcasing her ability to adapt to the challenges of remote work and effectively collaborate with stakeholders using various communication tools.

In today's remote work environment, it is important to highlight your adaptability and proficiency in remote collaboration tools. This demonstrates your ability to thrive in a remote role and effectively communicate with team members.

The cover letter could be further strengthened by mentioning specific projects or studies Maria has worked on, as well as any certifications or specialized training she has completed in the field of clinical research coordination.

Providing specific examples of projects you have worked on and highlighting relevant certifications or training helps to further establish your expertise and qualifications for the role.

Skills To Highlight

As a clinical research coordinator, your cover letter should highlight the unique skills that make you a strong candidate for the role. These key skills include:

Attention to Detail : Clinical research coordinators are responsible for ensuring accuracy and precision in all aspects of the research process. This includes meticulous documentation, data collection, and adherence to protocols. Highlight your ability to pay close attention to detail and provide examples of how your attention to detail has contributed to the success of previous research projects.

Organizational Skills : Clinical research coordinators are often responsible for managing multiple research projects simultaneously. Strong organizational skills are essential for keeping track of timelines, coordinating with research teams, and maintaining accurate records. Showcase your ability to effectively manage tasks, prioritize responsibilities, and meet deadlines.

Communication Skills : Effective communication is crucial for clinical research coordinators as they interact with various stakeholders, including investigators, sponsors, study participants, and regulatory authorities. Highlight your ability to communicate clearly and professionally, both verbally and in writing. Provide examples of how you have effectively communicated complex medical information to different audiences.

Clinical Trial Management : Clinical research coordinators play a key role in the management of clinical trials. They are responsible for coordinating study activities, recruiting and screening participants, obtaining informed consent, and ensuring compliance with study protocols. Emphasize your experience in managing clinical trials and your familiarity with the regulatory requirements and ethical considerations involved.

Regulatory Compliance : Clinical research coordinators are responsible for ensuring that all research activities comply with applicable regulations, guidelines, and ethical standards. Demonstrate your knowledge of regulatory requirements, such as Good Clinical Practice (GCP) guidelines and Institutional Review Board (IRB) processes. Mention any certifications or training you have received related to regulatory compliance.

By highlighting these key skills in your cover letter, you can demonstrate to potential employers that you have the necessary qualifications and abilities to excel as a clinical research coordinator.

Common Mistakes To Avoid

When crafting your cover letter for a clinical research coordinator position, it's important to avoid these common mistakes:

Not Addressing the Job Requirements : One of the biggest mistakes you can make is failing to address the specific job requirements mentioned in the job posting. Take the time to carefully read the job description and tailor your cover letter to highlight how your skills and experience align with what the employer is looking for. This shows that you have taken the time to understand the needs of the company and are genuinely interested in the role.

Using Generic Statements : Avoid using generic statements that could apply to any job. Instead, focus on providing specific examples of your experience and skills that are relevant to the clinical research coordinator role. Use concrete language to demonstrate your expertise in areas such as managing clinical trials, maintaining regulatory compliance, and coordinating research activities. Providing specific examples will make your cover letter stand out and show that you have the necessary qualifications for the position.

Failing to Showcase Experience in Clinical Trial Management : As a clinical research coordinator, it's crucial to highlight your experience in managing clinical trials. This includes coordinating study procedures, recruiting and screening participants, collecting and analyzing data, and ensuring compliance with regulatory requirements. Failure to emphasize your experience in these areas may give the impression that you are not a strong candidate for the position. Be sure to clearly articulate your experience and achievements in clinical trial management to demonstrate your ability to successfully carry out the responsibilities of a clinical research coordinator.

Not Highlighting How Your Expertise Can Address the Company's Needs : A cover letter is an opportunity to show how your expertise can help address the specific needs of the company. Research the organization and try to understand their current projects, goals, and challenges. Then, highlight how your skills and experience can contribute to the success of their clinical research efforts. This shows that you have taken the time to research and understand the company and are genuinely interested in making a positive impact.

By avoiding these common mistakes, you can create a strong and compelling cover letter that showcases your qualifications, experience, and enthusiasm for the clinical research coordinator role.

In conclusion, a well-crafted cover letter plays a crucial role in a clinical research coordinator's successful job application. It serves as an opportunity to showcase relevant skills, experience, and passion for the field of clinical research. By following the examples provided in this article, you can enhance your chances of landing a rewarding position in this competitive field.

Remember, the key takeaways from the cover letter examples include:

• Clearly stating your interest in the specific role and organization
• Highlighting relevant skills, experience, and achievements
• Demonstrating your knowledge of clinical research protocols and regulations
• Tailoring your cover letter to the job description and company culture

Avoid common mistakes such as generic or overly formal language, excessive detail, and neglecting to customize your cover letter for each application.

By taking the time to craft a compelling cover letter, you can stand out from other applicants and make a positive impression on hiring managers. Good luck with your clinical research coordinator job applications!

Clinical Research Associate Cover Letter Example for 2024 (Skills & Templates)

Create a standout clinical research associate cover letter with our online platform. browse professional templates for all levels and specialties. land your dream role today.

Are you interested in becoming a clinical research associate (CRA)? This guide provides you with the tips and tricks to writing a successful cover letter for your job application. Learn how to highlight your experience, knowledge, and skills to stand out from the competition and land that CRA position.

We will cover:

• How to write a cover letter, no matter your industry or job title.
• What to put on a cover letter to stand out.
• The top skills employers from every industry want to see.
• How to build a cover letter fast with our professional Cover Letter Builder .
• What a cover letter template is, and why you should use it.

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Clinical Research Associate Cover Letter Sample

Dear [Hiring Manager],

I am writing to apply for the Clinical Research Associate role at [company name]. With my experience in clinical research, I am confident that I have the qualifications and skills necessary to fill this role.

Having worked as a Clinical Research Associate for the past three years, I have developed a comprehensive understanding of the principles and techniques of clinical research. I have a proven track record of successfully carrying out clinical trials, organizing and analyzing data, and preparing reports for senior management. I have a strong knowledge of Good Clinical Practice (GCP) and other applicable regulations, and I am also well versed in the use of Microsoft Office, statistical software, and other data analysis tools.

In addition, I have exceptional written and verbal communication skills, which I have used to develop relationships with key personnel and stakeholders. I am also highly organized and detail-oriented, enabling me to manage multiple projects and tasks simultaneously. Finally, I am a quick learner and am always looking for ways to improve my knowledge and skills.

I am excited to join your team and contribute to the success of your clinical research programs. I believe I have the necessary skills and experience to make a positive impact in this role.

Thank you for your consideration. I look forward to discussing my candidacy further.

Sincerely, [Your name]

Why Do you Need a Clinical Research Associate Cover Letter?

A Clinical Research Associate cover letter is an essential part of your job application package. It is your opportunity to introduce yourself to the hiring manager and explain why you are the best candidate for the job. Here are some reasons why you need a Clinical Research Associate cover letter:

• Highlight your relevant experience: A cover letter allows you to highlight your relevant experience and qualifications for the position in a concise and easy to read format.
• Showcase your personality: A cover letter is a great way to showcase your personality and give the hiring manager an idea of who you are as a person.
• Stand out from the crowd: A well-written cover letter can help you stand out from the other applicants and make you more memorable to the hiring manager.
• Make a good impression: A cover letter can give you an opportunity to make a good impression on the hiring manager and show that you are a professional and serious about the job.

A Few Important Rules To Keep In Mind

• Start with a strong opening statement that clearly outlines your interest in the position and the company.
• Focus on what you have to offer the employer, rather than simply restating the job description.
• Highlight your most relevant experience and qualifications, and explain how they make you an ideal candidate for the position.
• Include specific examples of your skills and successes that demonstrate your ability to succeed in the role.
• Mention any awards, certifications, or impressive academic achievements that demonstrate your commitment to the field.
• Keep your letter concise and maintain a professional yet enthusiastic tone throughout.
• Proofread your letter several times to ensure that there are no grammar or spelling mistakes.
• End with a polite and confident closing statement that expresses your appreciation for the employer's consideration.

What's The Best Structure For Clinical Research Associate Cover Letters?

After creating an impressive Clinical Research Associate resume , the next step is crafting a compelling cover letter to accompany your job applications. It's essential to remember that your cover letter should maintain a formal tone and follow a recommended structure. But what exactly does this structure entail, and what key elements should be included in a Clinical Research Associate cover letter? Let's explore the guidelines and components that will make your cover letter stand out.

Key Components For Clinical Research Associate Cover Letters:

• Your contact information, including the date of writing
• The recipient's details, such as the company's name and the name of the addressee
• A professional greeting or salutation, like "Dear Mr. Levi,"
• An attention-grabbing opening statement to captivate the reader's interest
• A concise paragraph explaining why you are an excellent fit for the role
• Another paragraph highlighting why the position aligns with your career goals and aspirations
• A closing statement that reinforces your enthusiasm and suitability for the role
• A complimentary closing, such as "Regards" or "Sincerely," followed by your name
• An optional postscript (P.S.) to add a brief, impactful note or mention any additional relevant information.

Cover Letter Header

A header in a cover letter should typically include the following information:

• Your Full Name: Begin with your first and last name, written in a clear and legible format.
• Contact Information: Include your phone number, email address, and optionally, your mailing address. Providing multiple methods of contact ensures that the hiring manager can reach you easily.
• Date: Add the date on which you are writing the cover letter. This helps establish the timeline of your application.

It's important to place the header at the top of the cover letter, aligning it to the left or center of the page. This ensures that the reader can quickly identify your contact details and know when the cover letter was written.

Cover Letter Greeting / Salutation

A greeting in a cover letter should contain the following elements:

• Personalized Salutation: Address the hiring manager or the specific recipient of the cover letter by their name. If the name is not mentioned in the job posting or you are unsure about the recipient's name, it's acceptable to use a general salutation such as "Dear Hiring Manager" or "Dear [Company Name] Recruiting Team."
• Professional Tone: Maintain a formal and respectful tone throughout the greeting. Avoid using overly casual language or informal expressions.
• Correct Spelling and Title: Double-check the spelling of the recipient's name and ensure that you use the appropriate title (e.g., Mr., Ms., Dr., or Professor) if applicable. This shows attention to detail and professionalism.

For example, a suitable greeting could be "Dear Ms. Johnson," or "Dear Hiring Manager," depending on the information available. It's important to tailor the greeting to the specific recipient to create a personalized and professional tone for your cover letter.

Cover Letter Introduction

An introduction for a cover letter should capture the reader's attention and provide a brief overview of your background and interest in the position. Here's how an effective introduction should look:

• Opening Statement: Start with a strong opening sentence that immediately grabs the reader's attention. Consider mentioning your enthusiasm for the job opportunity or any specific aspect of the company or organization that sparked your interest.
• Brief Introduction: Provide a concise introduction of yourself and mention the specific position you are applying for. Include any relevant background information, such as your current role, educational background, or notable achievements that are directly related to the position.
• Connection to the Company: Demonstrate your knowledge of the company or organization and establish a connection between your skills and experiences with their mission, values, or industry. Showcasing your understanding and alignment with their goals helps to emphasize your fit for the role.
• Engaging Hook: Consider including a compelling sentence or two that highlights your unique selling points or key qualifications that make you stand out from other candidates. This can be a specific accomplishment, a relevant skill, or an experience that demonstrates your value as a potential employee.
• Transition to the Body: Conclude the introduction by smoothly transitioning to the main body of the cover letter, where you will provide more detailed information about your qualifications, experiences, and how they align with the requirements of the position.

By following these guidelines, your cover letter introduction will make a strong first impression and set the stage for the rest of your application.

Cover Letter Body

Dear Hiring Manager,

I am writing to apply for the role of Clinical Research Associate at your organization. With my experience in clinical research and study design, I am confident that I am an ideal candidate for this position.

I have a degree in Medical Science and have been working in clinical research for the past three years. During this time I have gained a deep understanding of clinical study design, Good Clinical Practices, and regulatory compliance. My experience has enabled me to plan and manage a variety of clinical research projects from start to finish, from initial study design to data collection and analysis. I have also regularly worked collaboratively with clinical teams to ensure that studies are conducted in accordance with applicable regulations.

I am an excellent communicator and have a knack for quickly grasping complex concepts. I have a knack for quickly grasping complex concepts and I am comfortable working with computerized data management systems. I am proficient with Microsoft Office Suite, SAS programs, and I am familiar with medical terminology.

I believe my experience and skills make me an ideal candidate for this position and I would be thrilled to join your team. I am confident that I can help you to achieve your research goals in a timely and efficient manner.

Thank you for your time and consideration. I look forward to hearing from you soon.

Sincerely, [Your Name]

Complimentary Close

The conclusion and signature of a cover letter provide a final opportunity to leave a positive impression and invite further action. Here's how the conclusion and signature of a cover letter should look:

• Summary of Interest: In the conclusion paragraph, summarize your interest in the position and reiterate your enthusiasm for the opportunity to contribute to the organization or school. Emphasize the value you can bring to the role and briefly mention your key qualifications or unique selling points.
• Appreciation and Gratitude: Express appreciation for the reader's time and consideration in reviewing your application. Thank them for the opportunity to be considered for the position and acknowledge any additional materials or documents you have included, such as references or a portfolio.
• Call to Action: Conclude the cover letter with a clear call to action. Indicate your availability for an interview or express your interest in discussing the opportunity further. Encourage the reader to contact you to schedule a meeting or provide any additional information they may require.
• Complimentary Closing: Choose a professional and appropriate complimentary closing to end your cover letter, such as "Sincerely," "Best Regards," or "Thank you." Ensure the closing reflects the overall tone and formality of the letter.
• Signature: Below the complimentary closing, leave space for your handwritten signature. Sign your name in ink using a legible and professional style. If you are submitting a digital or typed cover letter, you can simply type your full name.
• Typed Name: Beneath your signature, type your full name in a clear and readable font. This allows for easy identification and ensures clarity in case the handwritten signature is not clear.

Common Mistakes to Avoid When Writing a Clinical Research Associate Cover Letter

When crafting a cover letter, it's essential to present yourself in the best possible light to potential employers. However, there are common mistakes that can hinder your chances of making a strong impression. By being aware of these pitfalls and avoiding them, you can ensure that your cover letter effectively highlights your qualifications and stands out from the competition. In this article, we will explore some of the most common mistakes to avoid when writing a cover letter, providing you with valuable insights and practical tips to help you create a compelling and impactful introduction that captures the attention of hiring managers. Whether you're a seasoned professional or just starting your career journey, understanding these mistakes will greatly enhance your chances of success in the job application process. So, let's dive in and discover how to steer clear of these common missteps and create a standout cover letter that gets you noticed by potential employers.

• Forgetting to include contact information
• Using a generic and impersonal cover letter
• Not utilizing keywords and industry-specific language
• Not researching the company you are applying to
• Failing to explain how your skills and experiences are related to the job
• Not proofreading for typos and errors
• Adding irrelevant information

Key Takeaways For a Clinical Research Associate Cover Letter

• Highlight your experience in the clinical research field
• Focus on your attention to detail and organization
• Discuss your familiarity with regulatory guidelines
• Emphasize your communication skills
• Mention your ability to multi-task
• Showcase your problem-solving abilities

Resume Worded   |  Proven Resume Examples

• Resume Examples
• Research & Science Resumes

10 Clinical Research Resume Examples - Here's What Works In 2024

Clinical research is an important part of the pharmaceutical industry and helps us understand illnesses and create effective drugs to improve our health. this guide will show clinical researchers how to create winning resumes and progress in their clinical research careers..

Being a clinical researcher requires a very specific set of skills and extended research experience. Educationally, recruiters will be looking to see at least a bachelor’s degree in a life science subject. Beyond that, you need to show that you can use all industry standards research tools and that you understand clinical research procedures and regulations.

If you manage to get a job in this profession, you will be joining just over 7 thousand researchers (in the US), 61.7% of whom are women. You will most likely work in the education sector or the private sector, with those two sectors taking up around 73% of all clinical researchers.

Beyond your education and industry standards tools, your resume should indicate your great communication and teamwork skills as well as dedication to your work and critical thinking skills. This guide includes successful resume samples approved by recruiters, as well as some skills and action verb options that you could use to elevate your resume today.

Clinical Research Resume Templates

Jump to a template:

• Clinical Research Associate
• Clinical Research Coordinator
• Research Coordinator
• Clinical Pharmacist
• Clinical Manager
• Credentialing Specialist
• Clinical Data Manager
• Medical Science Liaison
• Clinical Trial Manager

Jump to a resource:

• Keywords for Clinical Research Resumes

Clinical Research Resume Tips

• Action Verbs to Use
• Related Medical Resumes

Get advice on each section of your resume:

Template 1 of 10: Clinical Research Associate Resume Example

A clinical research associate (CRA) is in charge of planning and coordinating the execution of clinical trials aimed at testing products. You will also serve as the contact person for doctors, patients, pharmacists, etc. This means you will need to have excellent skills and a strong clinical research background. Take a look at this recruiter-approved resume.

We're just getting the template ready for you, just a second left.

Tips to help you write your Clinical Research Associate resume in 2024

   show your career progression in medical research..

Show recruiters that you are a hardworking and successful researcher by showing an upwards trajectory of your medical research career. It will also show recruiters your dedication to your profession. This applicant started as a medical researcher and moved their way up to a clinical research associate.

   Include information about some of the medical trials you have conducted.

Conducting medical trials is a key part of your job. Give recruiters some insight into the kind of trials you have conducted. For example, this applicant has conducted trials on chest pain.

Skills you can include on your Clinical Research Associate resume

Template 2 of 10: clinical research coordinator resume example.

In this position, you will not be conducting the trials themselves but rather coordinating to ensure everything that needs to be done for the trial is done. This may include ensuring the finances and personnel needed are available, and that all related regulations and laws are followed. You will be reporting to a clinical principal investigator.

Tips to help you write your Clinical Research Coordinator resume in 2024

   include your strongest and most relevant abilities in the introduction..

Start your resume strong by including your strongest and most relevant skills and abilities in the introduction section. It sets a strong and impressive tone for the rest of your resume.

   Include relevant awards or recognition.

Awards show that not only do you do excellent work but that your work is good enough to receive recognition over others. This applicant has effectively added 2 relevant awards.

Skills you can include on your Clinical Research Coordinator resume

Template 3 of 10: research coordinator resume example.

In this position, you will be the support system for clinical trials and other lab investigations. You will not work directly on the trials but you will assist in any administrative work that needs to be done and ensure that the trials have everything that is needed and that they follow all guidelines. In essence, you will be coordinating all the moving parts that must work together to make a trial successful. Take a look at this successful resume sample.

Tips to help you write your Research Coordinator resume in 2024

   use coordinator keywords throughout your resume..

Using keywords related to coordinator functions is a great way to ensure that your resume highlights your coordinator experience. Some keywords this applicant uses include ‘spreadsheets’, ‘organizing’, and ‘WCAG’.

   Include student research experience.

If you do not have a lot of professional research and coordinator experience since graduating from school, you can include any student research experience you had. The skills used and experience gained would largely be the same as you would get from professional experience.

Skills you can include on your Research Coordinator resume

Template 4 of 10: clinical pharmacist resume example.

As a clinical pharmacist, your resume needs to convey your unique blend of patient care and technical knowledge. With recent industry trends leaning towards an increased involvement in patient management and care, clinical pharmacists are being called upon to be more hands-on. This makes it critical to showcase your experience and skills in direct patient care and health management on your resume. Keep in mind the increasing use of electronic health records (EHRs) across companies and facilities. A clinical pharmacist who is proficient in the latest EHRs systems is an asset, so don't forget to include your technical skills as well.

Tips to help you write your Clinical Pharmacist resume in 2024

   emphasize your patient care skills.

Clinical pharmacist roles have evolved to become more patient-oriented. This means when you're creating your resume, you should emphasize how you've directly contributed to patient care: adjusting medication plans, educating patients, or collaborating with other healthcare professionals for optimal patient outcomes.

   Showcase your proficiency in EHRs

As digital transformation sweeps through the healthcare sector, being tech-savvy is no longer optional for a clinical pharmacist. In your resume, it's crucial to highlight your proficiency in using electronic health records (EHRs). If you have experience using specific systems, list them.

Skills you can include on your Clinical Pharmacist resume

Template 5 of 10: clinical manager resume example.

Thinking of stepping into a Clinical Manager role? Well, it's a multi-faceted job that requires not just medical expertise, but solid management skills as well. The healthcare industry has seen a push for more efficiency and better patient care, and Clinical Managers play a crucial role in achieving these goals. As such, recruiters are on the lookout for those who can balance administrative tasks while ensuring top-notch medical service. When crafting your resume, it's important to demonstrate this balance clearly. Clinical Managers are now often expected to lead initiatives like electronic health record implementation or new healthcare regulations. This has made experience with project management and change leadership highly desirable. So, besides your clinical experience and skills, it's essential to showcase these aspects on your resume to stand out in today's market.

Tips to help you write your Clinical Manager resume in 2024

   show off your project management experience.

Clinical Managers are expected to lead major initiatives, so it's important to incorporate your project management experience on your resume. You should discuss specific projects you've managed, the teams involved, and the results achieved.

   Prove your proficiency in healthcare regulations

Given the rapidly changing landscape, compliance with healthcare regulations is crucial. Your resume should indicate your understanding of current healthcare laws, policies, and procedures. Mention any audit or compliance activities you've been involved in, and the outcomes.

Skills you can include on your Clinical Manager resume

Template 6 of 10: clinical manager resume example.

Clinical Managers navigate the busy intersection of healthcare administration and patient care, often working behind the scenes to keep hospitals or clinics running smoothly. The demand for these professionals is on the rise, with changes in healthcare policy and an increasingly aging population requiring efficient management. When writing your resume, it’s crucial to convey your capability to handle the administrative side of healthcare, while not losing sight of patient satisfaction and staff morale. As a Clinical Manager, you're expected to wear many hats, so your resume must reflect your multifaceted skill set, from project management to your understanding of healthcare regulations.

   Detail your understanding of healthcare policy

A Clinical Manager role often entails making decisions based on healthcare policy. Therefore, you should include any experience you have in interpreting healthcare policy changes and implementing policies in a clinical setting. This can illustrate your ability to navigate the complexities of the healthcare system effectively.

   Quantify your achievements in patient care quality

As a Clinical Manager, one of your key responsibilities is to manage and improve patient care quality. On your resume, go beyond simply listing this responsibility. Include metrics or quantifiable evidence of how your management improved patient care quality or increased patient satisfaction during your previous roles.

Template 7 of 10: Credentialing Specialist Resume Example

As a Credentialing Specialist, you're the gatekeeper of quality and competency within a healthcare setting. This role is critical and unique, seeing that you are the one verifying the qualifications and backgrounds of medical professionals. These are sensitive tasks, governed by specific rules and regulations. Recently, we've noticed a trend for Credentialing Specialists to have a more prominent role in healthcare compliance, so it's essential to emphasize your understanding of these aspects. When developing your resume, remember that you're marketing your unique skills and knowledge within this niche field. It's not just about listing job duties but showing how you've excelled in this role.

Tips to help you write your Credentialing Specialist resume in 2024

   show knowledge of compliance and regulations.

In your resume, it's essential you demonstrate your understanding of healthcare industry compliance and regulations. Mention specific laws, standards, or regulations you've worked with and how you ensured adherence within your organization.

   Experience with credentialing software

Credentialing Specialists often use specific software to track and manage information. If you're familiar with any of these systems, ensure you mention them. This shows you can hit the ground running without needing much training.

Skills you can include on your Credentialing Specialist resume

Template 8 of 10: clinical data manager resume example.

Clinical Data Managers oversee the complete lifecycle of clinical trials, from design and setup to data collection and analysis. Their role is pivotal in ensuring the accuracy and reliability of data used in healthcare decisions. Recently, there has been a surge in demand for this job, especially with the increase in remote clinical trials and focus on digital health. When crafting your resume for such a role, remember it's not just about showcasing your technical abilities, but also demonstrating your grasp of regulatory guidelines, data management best practices, and problem-solving skills. In the ever-evolving world of healthcare, staying updated with new technologies and methodologies is integral. Potential employers are on the lookout for Clinical Data Managers who keep up with industry trends and standard regulations. When preparing your resume, emphasize your continuously updated industry knowledge, understanding of the latest software, and ability to adapt and learn quickly.

Tips to help you write your Clinical Data Manager resume in 2024

   showcase your technical proficiency.

You should list and elaborate on the platforms and software you've used in data collection and management. Know your way around Oracle Clinical, Medidata RAVE, or SAS? Include these. It's essential to show that you're equipped with the necessary technical skills.

   Highlight Regulatory Knowledge

A Clinical Data Manager needs a solid understanding of regulations like HIPAA and FDA requirements. Make sure your resume reflects your familiarity with these regulations and any successful audits or inspections you've handled.

Skills you can include on your Clinical Data Manager resume

Template 9 of 10: medical science liaison resume example.

As a Medical Science Liaison (MSL), you're a bridge between pharmaceutical companies and healthcare professionals. This role is all about translating complex scientific information into digestible insights that help improve patient care. The MSL industry has evolved recently, with an emphasis on demonstrating value to healthcare providers beyond just providing data. Your resume needs to show hiring managers that you're not only a capable mediator, but also that you’re up-to-date on the latest industry trends. Further, it's pivotal to illustrate your ability to build and maintain relationships, lead educational trainings, and ensure compliance with industry regulations.

Tips to help you write your Medical Science Liaison resume in 2024

   showcase your scientific expertise.

Your resume should detail your deep understanding of the therapeutic area you'll be working in. While your degree(s) will show your academic qualifications, use your experience section to highlight specific projects or initiatives where you've applied this knowledge.

   Evidence of relationship-building skills

MSL roles require the ability to build and maintain relationships with key opinion leaders in the healthcare field. Use your resume to show how you've successfully built these relationships in the past, whether through network development, clinical trial collaboration, or peer-to-peer education.

Skills you can include on your Medical Science Liaison resume

Template 10 of 10: clinical trial manager resume example.

As a Clinical Trial Manager, you're in the exciting and challenging world of managing clinical research activities. This role often involves collaborating with different stakeholders and ensuring clinical trials are executed properly, safely, and ethically. Over the past few years, the industry has seen an increase in the use of technology and data analysis, so understanding these trends can give your resume an edge. When crafting your resume, it's crucial to show not only your knowledge in managing clinical trials but also your ability to adapt to new technologies and relevant regulations. Your resume is your opportunity to showcase your experiences and achievements. It should tell the story of how you've successfully managed trials and navigated regulatory requirements. It's not just about listing your previous roles, but about showing how your unique contributions have made a difference in those positions. In doing so, remember to quantify your achievements where possible.

Tips to help you write your Clinical Trial Manager resume in 2024

   include certifications and relevant qualifications.

Beyond your educational background, it's crucial to include any certifications or qualifications related to clinical trial management. Certifications like Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA) show you're well-qualified and committed to staying current in the field.

   Detail your experience with technology and data analysis

Given the rise of technology in clinical trials, it's wise to detail any experience you have with relevant software, databases, and data analysis. Showing your proficiency in using electronic data capture systems or statistical software can make your resume stand out to a hiring manager.

Skills you can include on your Clinical Trial Manager resume

We spoke with hiring managers at leading clinical research organizations, including Pfizer, Johnson & Johnson, and Novartis, to gather their insights on what makes a strong clinical research resume. Based on their feedback and our analysis of successful resumes in this field, we've compiled a list of essential tips to help you craft a compelling clinical research resume that will catch the attention of employers and increase your chances of landing an interview.

   Highlight your clinical research experience

Employers want to see that you have hands-on experience in clinical research. When describing your work history, focus on your specific roles and responsibilities in clinical trials.

• Managed a Phase III clinical trial for a novel cancer treatment, overseeing a team of 12 research associates and ensuring compliance with FDA regulations
• Conducted patient recruitment and enrollment for a 500-participant cardiovascular study, exceeding target enrollment by 15%

Avoid vague or general descriptions that don't showcase your unique contributions:

• Worked on various clinical trials
• Assisted with patient recruitment and data collection

   Showcase your therapeutic area expertise

Many clinical research positions require specialized knowledge in specific therapeutic areas, such as oncology, neurology, or infectious diseases. If you have experience or training in a particular area, make sure to highlight this on your resume.

• Conducted clinical trials for novel immunotherapies in the treatment of melanoma and lung cancer
• Collaborated with neurology specialists to develop protocols for a Phase II study on Alzheimer's disease

If you lack direct experience in a therapeutic area, consider emphasizing any relevant coursework, certifications, or personal research you've conducted to demonstrate your interest and knowledge.

   Demonstrate your knowledge of regulatory requirements

Clinical research is heavily regulated, and employers value candidates who have a strong understanding of relevant guidelines and regulations, such as Good Clinical Practice (GCP) and FDA requirements.

• Ensured compliance with ICH-GCP guidelines and local regulatory requirements for a global Phase III trial
• Collaborated with Quality Assurance to prepare for FDA audits and maintain inspection-readiness

If you have completed any training or certifications related to regulatory compliance, such as NIH Human Subjects Protection or HIPAA training, make sure to include these on your resume as well.

   Quantify your achievements

Whenever possible, use specific metrics to quantify your accomplishments and demonstrate the impact of your work. This helps employers better understand the scope and significance of your contributions.

• Managed a $5 million budget for a global Phase III clinical trial, ensuring all milestones were met on time and within budget
• Implemented a new electronic data capture system, reducing data entry errors by 30% and saving an estimated 200 hours per month

Avoid using vague or subjective terms to describe your achievements:

Successfully managed large budgets and improved data quality for several clinical trials

   Tailor your resume to the job description

Customize your resume for each job application to highlight the skills and experiences that are most relevant to the position. Carefully review the job description and incorporate keywords and phrases that align with the employer's requirements.

For example, if a job posting emphasizes experience with oncology clinical trials, make sure to prioritize any relevant oncology experience on your resume:

• Managed a Phase II clinical trial for a novel targeted therapy in advanced non-small cell lung cancer
• Collaborated with oncologists to develop study protocols and ensure patient safety in a first-in-human solid tumor trial

   Include relevant certifications and professional development

In addition to your formal education, include any relevant certifications or professional development courses you have completed. These can demonstrate your commitment to staying current in the field and expanding your skill set.

• Certified Clinical Research Professional (CCRP) - Association of Clinical Research Professionals
• Completed NIH Good Clinical Practice (GCP) and HIPAA Privacy Rule Training

If you have attended any conferences, workshops, or seminars related to clinical research, consider including these as well, especially if you presented or contributed to the event in some way.

Writing Your Clinical Research Resume: Section By Section

  header, 1. include your full name and key contact details.

Your header should include your full name, phone number, and email address. If you have a professional website or LinkedIn profile, you can include those links as well. Make sure your email address is professional and avoid using nicknames or aliases.

• John Doe, Ph.D. | 123-456-7890 | [email protected] | linkedin.com/in/johndoe
• Jane Smith, M.S. | 987-654-3210 | [email protected] | janesmith.com

Avoid cluttering your header with unnecessary details or unprofessional email addresses like the following:

• John "Johnny" Doe | 123-456-7890 | [email protected] | 123 Main St, Anytown USA

2. Highlight relevant credentials and certifications

If you have relevant credentials or certifications for clinical research, such as a CCRP (Certified Clinical Research Professional) or a SOCRA certification, include them after your name. This helps establish your credibility and expertise right from the start.

• John Doe, Ph.D., CCRP | 123-456-7890 | [email protected]
• Jane Smith, M.S., SOCRA-certified | 987-654-3210 | [email protected]

However, avoid listing irrelevant or outdated certifications that don't directly apply to clinical research roles, such as:

• John Doe, CPR-certified, OSHA 30 | 123-456-7890 | [email protected]

3. Keep it simple and easy to read

Your header should be clean, concise, and easy to read at a glance. Use a clear font and simple formatting. Avoid using multiple colors, graphics, or complex layouts that can distract from the key information.

John Doe, Ph.D. Clinical Research Associate 123-456-7890 | [email protected] | linkedin.com/in/johndoe

Compare that to an overly complex header like this:

Dr. John Doe, Ph.D., CCRP, ACRP Senior Clinical Research Associate | Data Manager | Project Leader 123-456-7890 | [email protected] 123 Main St, Anytown, USA 12345 linkedin.com/in/johndoe | facebook.com/johndoe | twitter.com/johndoe

Keep it simple and focused on the most important details.

  Summary

A resume summary, also known as a professional summary or summary statement, is an optional section that sits at the top of your resume, just below your contact information. It provides a brief overview of your professional background, skills, and accomplishments, giving hiring managers a quick snapshot of what you bring to the table.

While a summary is not strictly necessary, it can be particularly useful if you are a career changer or have a diverse background that may not be immediately apparent from your work history. It allows you to provide context and connect the dots for the reader. However, avoid using an objective statement, which focuses on your goals rather than what you can offer the employer.

To learn how to write an effective resume summary for your Clinical Research resume, or figure out if you need one, please read Clinical Research Resume Summary Examples , or Clinical Research Resume Objective Examples .

1. Tailor your summary to the clinical research role

When crafting your summary for a clinical research position, it's essential to align your skills and experience with the requirements of the role. Research the position and the company to identify the key qualifications they are seeking.

For example, if the job emphasizes experience with clinical trial protocols, you might write:

• Clinical Research Associate with 5+ years of experience in managing and executing clinical trial protocols for Phase I-III studies.

In contrast, a generic summary like the following doesn't provide any specific information relevant to clinical research:

• Experienced professional seeking a challenging position in a reputable organization where I can utilize my skills and knowledge.

2. Highlight your clinical research skills and achievements

Your summary is the perfect place to showcase your most impressive clinical research skills and accomplishments. Focus on the specific expertise and experiences that make you a strong candidate for the role.

Instead of simply listing your skills, quantify your achievements to make them more impactful. For instance:

• Managed a portfolio of 10+ clinical trials, ensuring compliance with FDA regulations and GCP guidelines.
• Collaborated with cross-functional teams to develop and implement study protocols, leading to a 20% reduction in study start-up time.

Avoid using vague or generic phrases that don't provide any concrete information, such as:

• Skilled in clinical research.
• Proven track record of success.

3. Keep your summary concise and objective

Your resume summary should be a brief, high-level overview of your professional profile. Aim for a few concise sentences or bullet points that encapsulate your most relevant qualifications and experiences. A good rule of thumb is to keep your summary to around 50-100 words.

Clinical Research Coordinator with 3+ years of experience in oncology clinical trials. Skilled in patient recruitment, informed consent, and data management. Collaborated with investigators to ensure protocol compliance and patient safety. Seeking to leverage expertise to contribute to groundbreaking research at XYZ Pharmaceuticals.

Avoid writing a lengthy or overly detailed summary that reads like a dense paragraph. Also, steer clear of subjective statements or self-assessments, such as:

Highly motivated and hardworking individual with a passion for clinical research. I am a team player with excellent communication skills and a strong work ethic. My goal is to secure a challenging position where I can grow and make a difference.

  Experience

The work experience section is the heart of your resume. It's where you show potential employers what you've accomplished in previous roles and how you can add value in the position you're applying for. When writing your work experience section for a clinical research role, focus on highlighting your relevant skills, achievements, and impact.

1. Tailor your bullet points to the job description

When applying for a clinical research role, it's crucial to align your work experience with the requirements and responsibilities listed in the job description. This demonstrates to the hiring manager that you have the relevant skills and experience they're looking for.

For example, if the job description mentions experience with clinical trial protocols, you could include a bullet point like:

• Developed and implemented clinical trial protocols for a Phase III study, ensuring adherence to FDA regulations and GCP guidelines

In contrast, a generic bullet point that doesn't relate to the job description might look like:

• Assisted with various tasks in the clinical research department

2. Quantify your achievements with metrics

Numbers and metrics help to contextualize your achievements and make them more impactful. They give the hiring manager a clear picture of the scale and scope of your work. When possible, include specific numbers and percentages to quantify your accomplishments.

Here are some examples of how to incorporate metrics:

• Managed a clinical trial with 150+ participants across 5 sites, resulting in a 95% retention rate
• Reduced data query resolution time by 30% through implementing a new workflow process
• Co-authored 3 peer-reviewed publications in top-tier medical journals

3. Highlight relevant tools and technologies

Clinical research often involves using various tools and technologies, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), and statistical analysis software. Showcasing your proficiency with these tools demonstrates your technical skills and ability to work efficiently in a clinical research setting.

For example:

• Proficient in using EDC systems such as Medidata Rave and Oracle Clinical
• Experienced in managing clinical trial data using CTMS platforms like Veeva Vault and Oracle Siebel
• Skilled in conducting statistical analyses using SAS and R

4. Showcase your career progression

Highlighting your career growth within the clinical research field shows your dedication, adaptability, and potential for future growth. If you've been promoted or taken on increasing responsibilities in your previous roles, make sure to emphasize this in your work experience section.

Clinical Research Associate, XYZ Pharmaceuticals Jan 2018 - Present - Promoted from Clinical Research Coordinator to Clinical Research Associate within 2 years due to outstanding performance and leadership skills - Manage a portfolio of 8 clinical trials, overseeing all aspects of study conduct from start-up to close-out - Serve as a mentor to junior CRCs, providing training and guidance on study protocols and GCP compliance

  Education

Your education section is a key part of your clinical research resume. It shows hiring managers that you have the necessary qualifications and background to excel in the role. Follow these tips to make sure your education section is effective and compelling.

1. Put education at the top if you're a recent grad

If you graduated within the last few years, place your education section above your work experience. This highlights your most relevant qualification first. For example:

Bachelor of Science in Biology University of California, Los Angeles Graduated: May 2022 Relevant Coursework: Clinical Research Methods Biostatistics Pharmacology

Avoid this mistake:

• Listing your high school diploma when you have a college degree
• Placing education at the bottom if it's your strongest qualification

2. Keep it concise if you're experienced

If you have several years of clinical research experience, keep your education section brief. Place it below your work history and simply list your degree, school, and graduation year. For example:

M.S. Biomedical Sciences, University of Pennsylvania B.S. Biology, Boston University

Seasoned professionals should avoid:

• Listing graduation dates, which may lead to ageism
• Including coursework or irrelevant details that distract from work accomplishments

3. Highlight clinical research certifications

Clinical research certifications demonstrate your expertise and qualifications. You can list them in your education section or a separate certifications section. For example:

• Certified Clinical Research Professional (CCRP), SOCRA
• Certified Clinical Research Coordinator (CCRC), ACRP

Certifications to avoid listing:

• Online course completion certificates
• Expired or irrelevant certifications
• Memberships or affiliations not directly related to clinical research

Action Verbs For Clinical Research Resumes

Action verbs are a powerful way to frame your achievements and experience effectively. They can be used to make your abilities look diverse and your achievements look impressive. For a clinical researcher, you need your action verbs to show that you are skilled in multiple stages of the research process. They also need to highlight your successes and show recruiters that you work well in teams and that your work has borne fruit.

This is a sample of action verbs that can be used to elevate your resume. Use those that apply most to your experience.

• Coordinated
• Collaborated

For more related action verbs, visit Medical Action Verbs .

For a full list of effective resume action verbs, visit Resume Action Verbs .

Action Verbs for Clinical Research Resumes

Skills for clinical research resumes.

This profession is very technical and as such your skills section should reflect that technical nature. For one, you should show that you are well-versed in the regulations and industry expectations of your research so include things like ‘Good Clinical Practice (GCP)’. 

You also need to show that you are experienced in using the industry standard tools for clinical research. If you can find out the tools used by the company you are applying to, add all those tools to your list. Ensure you do a crash course in the tools you are not familiar with, before adding them to your tools section.

It would also be beneficial to include the areas of healthcare that you have done clinical research in. For example, specify ‘Oncology clinical research’ instead of only listing ‘clinical research’. It helps give recruiters a more clear understanding of your research background.

Here is a list of skills that would be beneficial to add to your skills section.

• Good Clinical Practice (GCP)
• Clinical Monitoring
• Clinical Trial Management System (CTMS)
• Electronic Data Capture (EDC)
• Clinical Trials
• Clinical Research
• Clinical Development
• CRO Management
• Clinical Research Associates
• Clinical Data Management
• Standard Operating Procedure (SOP)
• Therapeutic Areas
• Clinical Operations
• Oncology Clinical Research
• Regulatory Submissions
• U.S. Food and Drug Administration (FDA)
• Clinical Site Monitoring
• Biotechnology

How To Write Your Skills Section On a Clinical Research Resumes

You can include the above skills in a dedicated Skills section on your resume, or weave them in your experience. Here's how you might create your dedicated skills section:

Skills Word Cloud For Clinical Research Resumes

This word cloud highlights the important keywords that appear on Clinical Research job descriptions and resumes. The bigger the word, the more frequently it appears on job postings, and the more 'important' it is.

How to use these skills?

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Clinical Research Associate

Clinical Research Associate Cover Letter

You have the skills and we have tricks on how to find amazing jobs. Get cover letters for over 900 professions.

• Anna Hmara - Career Expert

How to create a good cover letter for a clinical research associate: free tips and tricks

Nowadays writing an engaging job application document for resume is inevitable if you’re aiming to land a good job. Cover letters act as a preliminary screening procedure that hiring specialists use to make their job easier. Cheer up! With clear-cut yet simple recommendations you’ll draft your letter in a jiffy. The clinical research associate cover letter example below will guide you in this endeavor.

Do extensive research. Before you even get down to writing, you need to find as much information on the company as possible. Getting familiar with their projects and actual numbers will give you an advantage over others who fail to do so. Besides, you’ll need to know such trifles as the recruiter’s name.

Do ‘I’ all the time. Be careful with grammatical constructions. Remember not to start all your sentences with ‘I.’ First, it looks like a lack of proper English. Second, it implies your excessive focus on self, whereas you should be focused on the employer’s benefit.

Make the second paragraph meaty. The middle section of your CL tells your professional story. You can mention your educational background and undergraduate research, if relevant. Be specific about the skills you gained and projects you took on.

Stay away from generic descriptions. It is difficult to get away from watery content if you write about something in general. However, if you focus on examples from your life, you’ll find it much easier to come up with unique ways of telling about it.

Use keywords. You can look them up in the job listing. Thus, the recruiter sees immediately that you know what you’re talking about.

Don’t use too complicated phrases. Speak simple English. It doesn’t mean primitive. However, if you should not exhaust the reader by tangled sentences.

Sample cover letter for a clinical research associate position

The most effective way to digest the tips is to see their practical application. We have used all the important tips of the above units into a single a clinical research associate cover letter sample to demonstrate a winning document that can be created in GetCoverLetter editor.

Nicole Copperwaren Clinical Research Associate 175 Marshall Avenue 8765-876-987 / [email protected] Rowan Selznick Recruiter of Unique Human Company

Dear Rowan, In reference to your job posting on LinkedIn, I would like to suggest my candidacy for the Clinical Research Associate position at Unique Human Company. Two years of hands-on experience in clinical research trials complete with my Master’s in Biochemistry enable me to bring a significant contribution to the success of your company.

When in BioTech Corporation, I was working under the guidance of Professor Jackson Mortimer and learned to collect and analyze data from clinical research trials. I carried out daily monitoring of tests and participants, prepared reports and presentations and drafted articles for publication. A couple of the articles I worked on were published in PubMed after Professor Mortimer’s corrections and additions.

I am excited to start working in your organization as I have great respect to high standards and working policies of Unique Human Company. My soft skills and professional qualifications make me a perfect fit for this position, so I kindly ask you to review my resume in the attachment. Acting in the role of Clinical Research Associate, you will contribute to the success of your mission.

Hoping for an interview, I give you my best wishes, and I am looking forward to meeting you in person. Here are my contacts [email protected] and phone 7569847694.

Sincerely, Nicole.

This example is not commercial and has a demonstrative function only. If you need unique Cover Letter please proceed to our editor.

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How to save time on creating your cover letter for a clinical research associate

Our Get Cover Letter editor will help you make the process easy and fast. How it works:

Fill in a simple questionnaire to provide the needed information about yourself.

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The GetCoverLetter editor is open to any goals of applicants. Whether it be a presentation of a craft professional with a great list of achievements or even a clinical research associate without experience. Rest assured, the opportunities are equal for all the candidates.

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Templates of the best a clinical research associate cover letter designs

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Frequently Asked Questions

The more unique the knowledge you get, the more space for new questions. Do not be affraid to miss some aspects of creating your excellent cover letter. Here we took into account the most popular doubts to save your time and arm you with basic information.

• What should my a clinical research associate cover letter contain? The main purpose of a cover letter is to introduce yourself, mention the job you’re applying for, show that your skills and experience match the needed skills and experience for the job.
• How to properly introduce yourself in a cover letter? Greet the correct person to which your cover is intended for. Introduce yourself with enthusiasm.
• How many pages should my cover letter be? Your cover letter should only be a half a page to one full page. Your cover letter should be divided into three or four short paragraphs.
• Don't focus on yourself too much
• Don't share all the details of every job you've had
• Don't write a novel

You have finished your acquaintance with valuable tips and tricks. Now is the time to create your own perfect cover letter.

Other cover letters from this industry

More docs for any taste – short, long, for newbies, for seasoned veterans, you name it. Visit any of the links below and see for yourself.

• Clinical Research Coordinator

Professional Clinical Research Coordinator Cover Letter Examples for 2024

Your clinical research coordinator cover letter must immediately highlight your proficiency in managing clinical trials. It is essential to demonstrate your skill in coordinating with researchers and participants effectively. In your cover letter, illustrate your ability to handle data with precision and care. Showcase your exceptional organizational skills required to maintain comprehensive study documentation and comply with regulatory standards.

Cover Letter Guide

Clinical Research Coordinator Cover Letter Sample

Cover Letter Format

Cover Letter Salutation

Cover Letter Introduction

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No Experience Clinical Research Coordinator Cover Letter

Key Takeaways

Crafting a clinical research coordinator cover letter can be daunting, especially when you realize it's a crucial piece of your job application puzzle. You want to stand out, not just rehash your resume. Think of showcasing that one professional triumph you're beaming with pride over; tell its story, engage the reader without falling into the trap of clichés. Remember, your goal is to impress without overwhelming — keep it sharp, focused, and no more than one page. Let's dive in and make your cover letter a true reflection of your potential.

• Including all the must-have paragraphs in your structure for an excellent first impression;
• Learning how to write individual sections from industry-leading cover letter examples;
• Selecting the best accomplishment to tell an interesting and authority-building professional story;
• Introducing your profile with personality, while meeting industry standards.

And, if you want to save some time, drag and drop your clinical research coordinator resume into Enhancv's AI, which will assess your profile and write your job-winning cover letter for you.

If the clinical research coordinator isn't exactly the one you're looking for we have a plethora of cover letter examples for jobs like this one:

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Clinical Research Coordinator cover letter example

Carter Andrade

San Antonio, Texas

+1-(234)-555-1234

[email protected]

• Tailored Experience: The cover letter highlights specific accomplishments relevant to the role, such as leading a pivotal study and increasing patient recruitment by 40%, demonstrating the applicant's direct impact in a similar position.
• Relevant Skills: It outlines key skills necessary for the role, including the ability to manage intricate projects and team leadership, which parallels the needs of the hiring organization.
• Competency Demonstration: The applicant aligns past achievements with the goals of the potential employer, suggesting that their expertise can contribute to the organization’s success in medical research and specifically in dermatology.
• Call to Action: The cover letter closes with an invitation to discuss further how the applicant’s experience and skills could benefit the organization, prompting the hiring manager to consider the applicant for an interview.

What should your clinical research coordinator cover letter look like - formatting and organizing your information

Have you ever wondered what are the must-have sections you need to include in your clinical research coordinator cover letter? Our builder sets those up for you with:

• Header - dedicated to your contact information, the role you're applying for, and the date (don't forget to include your name);
• Greeting and opening paragraph - to create a personalized and memorable experience for recruiters;
• Body paragraph - emphasizing your skill set and knowledge that aligns with the role and helps you to stand out;
• Closing paragraph - leaving a great impression and ending with an optional signature.

Use a cover letter template to discover the best formatting for your clinical research coordinator cover letter: that is single-spaced paragraphs and wrapping your content in a one-inch margin.

Ensure that both your resume and clinical research coordinator cover letter are in the same font . Stand apart from the crowd by using modern, yet simple fonts, like Chivo and Rubik, instead of the overused Arial and Times New Roman.

Did you know that the Applicant Tracker System (or ATS) won't be assessing your clinical research coordinator cover letter? Instead, submit your profile in PDF to recruiters to keep the same formatting and the design intact.

The top sections on a clinical research coordinator cover letter

• Header: This includes your contact information, date, and the employer's details, which is essential for a professional layout and ensures that the recruiter knows whom the cover letter is from and how to get in contact with you.
• Greeting: A personalized salutation addresses the hiring manager or the research team leader directly, showing that you've done your homework and are serious about wanting the position.
• Introduction: Briefly introduce yourself, mentioning your role as a Clinical Research Coordinator and your excitement about the opportunity, which helps to make a strong first impression that ties your experience to the job role.
• Body: Highlight your experience in clinical trial management, compliance with regulatory guidelines, and your ability to coordinate research activities effectively, as these are key responsibilities in the role that recruiters will be looking for.
• Closing: Include a call-to-action that expresses your eagerness to discuss how your skills can contribute specifically to their ongoing research projects, followed by a professional sign-off.

Key qualities recruiters search for in a candidate’s cover letter

• Familiarity with Good Clinical Practice (GCP) and regulatory compliance: This ensures adherence to ethical standards and regulatory mandates during clinical trials.
• Experience with patient recruitment and enrollment: Vital for efficiently managing the logistics of clinical studies and maintaining steady participant flow.
• Detail-oriented project management skills: Critical for successfully coordinating complex research activities and timelines, while ensuring data quality.
• Strong interpersonal and communication skills: Necessary to liaise with diverse stakeholders, including investigators, participants, and regulatory bodies.
• Proficiency in data management and electronic data capture systems: Important for accurate data collection, analysis, and maintenance of participant confidentiality.
• Ethical integrity and patient-centric focus: Recruiters look for individuals who prioritize participant safety and ethical considerations in clinical research.

What greeting should you use in your clinical research coordinator cover letter salutation

A simple "Hello" or "Hey" just won't work.

With your clinical research coordinator cover letter salutation , you set the tone of the whole communication.

You should thus address the hiring managers by using their first (or last name) in your greeting.

But how do you find out who's recruiting for the role?

The easiest way is to look up the role on LinkedIn or the corporate website.

Alternatively, you could also contact the organization via social media or email, for more information.

Unable to still obtain the recruiter's name?

Don't go down the "To whom it may concern path". Instead, start your cover letter with a "Dear HR team".

List of salutations you can use

• Dear Hiring Manager,
• Dear [Name of the Principal Investigator],
• Dear [Name of the HR Director],
• Dear Dr. [Last Name],
• Dear Professor [Last Name],
• Dear [Name of the Research Team Leader],

First introductions in your clinical research coordinator cover letter

Within your clinical research coordinator cover letter introduction , genuinely state what you like about the organization.

Research the latest company projects, honorary awards, company updates, etc.

Write up to two sentences to let recruiters know what impresses you about the company,

This would help you to set a good tone for the rest of the communication.

Structuring your clinical research coordinator cover letter body to add more value

You've hinted at your value as a professional (this may be your passion for the job or interest in the company) in your introduction.

Next, it's time to pan out the body or middle of your clinical research coordinator cover letter .

When creating your resume, you've probably gone over the advert a million times to select the most relevant skills.

Well, it's time to repeat this activity. Or just copy and paste your previous list of job-crucial requirements.

Then, select one of your past accomplishments, which is relevant and would impress hiring managers.

Write between three and six paragraphs to focus on the value your professional achievement would bring to your potential, new organization.

Tell a story around your success that ultimately shows off your real value as a professional.

A sincere and original way to end your clinical research coordinator cover letter

When writing their clinical research coordinator cover letter, candidates tend to use one of these phrases, "Sincerely yours" or "I look forward to hearing from you".

Both statements show good manners, but your cover letter should end in a more actionable manner .

Write about:

• how you see yourself growing in the role/organization;
• the benefits you would bring about (you'd impress even more with tangible metrics);
• the next steps in the process (provide your availability for interviews).

Which story should you tell in your clinical research coordinator cover letter when you have zero experience

Candidates, lacking professional experience in the field - this one is for you.

Your clinical research coordinator cover letter is an exercise of integrity, honesty, and, above all, spinning a positive narrative around your strengths.

And what better way to capture recruiters' attention than with your most job-relevant achievement (this could be from your internship or volunteering experience)?

Make sure to back up your success with transferrable skills that are relevant to the job (e.g. how your year, studying abroad, has taught you to be more motivated and handle multicultural environments).

Another safe card you can bet on is your career dream: in the body of your clinical research coordinator cover letter, go into the details of how your ambitions would help make the company you're applying for better.

Key takeaways

Writing your clinical research coordinator cover letter has never been easier, so remember to:

• Select a clinical research coordinator cover letter template that automatically meets industry formatting (e.g. has one-inch margins, is single-spaced, is in PDF, etc.);
• Make your clinical research coordinator cover letter personal by mentioning the recruiters' first or last name;
• Within the introduction, describe what you like best about the company in no more than two sentences;
• Use your clinical research coordinator cover letter body to tell a story of your greatest achievement, backed up by job-relevant skills and technologies;
• If you have no professional experience, be honest about it in your clinical research coordinator cover letter, but also write about your unique talents.

Cover letter examples by industry

AI cover letter writer, powered by ChatGPT

Enhancv harnesses the capabilities of ChatGPT to provide a streamlined interface designed specifically focused on composing a compelling cover letter without the hassle of thinking about formatting and wording.

• Content tailored to the job posting you're applying for
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Ideal Cover Letter Length: How Long Should A Cover Letter Be?

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Clinical Research Associate Cover Letter Example

A Clinical Research Associate is an individual who monitors and evaluates the stages involved in the clinical trials of medicines. He sets up the trial study locations and assists the trial investigators. He develops the trial protocols which consist of the methodology on how to conduct trials. He prepares reports on the study and analyses the progress and the results.

Write your perfect Clinical Research Associate Cover Letter using our sample and professional writing tips. To make things easier, we have come up with a simple and convenient cover letter builder to help you get your dream job.

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• Healthcare & Wellbeing

What to Include in a Clinical Research Associate Cover Letter?

Roles and responsibilities.

A Clinical Research Associate coordinates with the committee that keeps track of the safety, well-being, and rights of the subject taking the trial. He liaises with different consultants and researchers while conducting the trials. He trains the staff and junior research associates to conduct the trials using trial-specific industry regulations. He archives the relevant study documents and related correspondences after the trial is completed.

• Coordinate patient visits and procedures related to research.
• Act as a resource for study participants by answering questions and explaining related procedures.
• Ensure the study site is in compliance with all local and federal laws and regulations.
• Monitor study sites and activities to ensure the appropriate industry protocols and terms of the study are being followed.
• Oversee the hiring and training of staff members who are working on the study.
• Create thorough documentation of study protocol and update it as needed.

Education & Skills

Additionally, the cover letter for Clinical Research Associate should mention the following skillset :

• Knowledge of relevant health and safety laws.
• Knowledge of medical sciences.
• Communication skills.
• Organizational skills.
• Time management skills.

Successful cover letters for a Clinical Research Associate often mention the following qualification(s):

• Bachelor’s or Master’s degree in Nursing, Life Sciences, or Medical Sciences; proven work experience.

Clinical Research Associate Cover Letter Example (Text Version)

Dear Mr./Ms.,

This letter is regarding my interest in applying for the post of Clinical Research Associate at your company. With my advanced qualification and experience in the field of Research and Medical Sciences, combined with my organizational and team collaboration skills, I am certain that I would significantly benefit your Research Centre.

[XXX Hospital and Research Centre] is one of the most famous and trusted hospitals in the district. The hospital’s diversified work which incorporates traditional medicinal ideas and modern technology has never failed to amaze me. I would be honored to be a part of an ambitious Centre.

I have a Master’s degree in Medical Sciences with a specialization in Pharmaceutical medicines. I currently work at [YYY Medical Centre] where I perform the following duties and tasks:

• Assisted in the testing of 64 medicinal trials.
• Reviewed and analyzed documents and cross-evaluated the submissions of the IRB trials.
• Assisted in the drafting of trial protocols, standard reports, subject-consent forms, and rights.
• Monitored the final result data to decrease discrepancies in the provided.
• Increased the recruitment rate of assisting staff by 15%.

I bring strong expertise in medical science and research evaluation. My interpersonal skills allow me to work with professionals as well as trial participants. My experience has offered me an effective and well-rounded and skill-set that is relevant to the field. I believe that I could be an asset to your Medical Centre.

I look forward to meeting you in person so that we can discuss the opportunity in detail. Thank you for your time and consideration.

Sincerely, [Your Name]

A noteworthy Clinical Research Associate Cover Letter should highlight and focus on key career achievements and expertise that make you particularly suited to perform well in the position. Include statements about your enthusiasm regarding the role. Use our Clinical Research Associate Resume Sample to create a good resume and increase your chances of getting your dream job.

Customize Clinical Research Associate Cover Letter

Get hired faster with our free cover letter template designed to land you the perfect position.

Related Healthcare & Wellbeing Cover Letters

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Clinical Research Associate Resume Samples

The guide to resume tailoring.

Guide the recruiter to the conclusion that you are the best candidate for the clinical research associate job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies, tailor your resume & cover letter with wording that best fits for each job you apply.

Create a Resume in Minutes with Professional Resume Templates

• Make recommendations for improvements to your Manager
• Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA
• Independently performs CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems
• Reviews clinical data/information and oversees data correction. Assists study managers in providing interim and final reports and presentations
• Works under supervision to manage work flow to accomplish assigned objectives
• May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes
• Working with management to develop project-specific CRA training
• Assists the Project Manager/Clinical Trial Manager with UAT testing and eCRF guideline review
• Monitors site performance and compliance and provide management with necessary reports, updates and recommendations
• Develops Clinical Monitoring Plans with review from the CRA Manager
• Assists in evaluation of vendor performance during conduct of the study
• Assists in the preparation and review of protocols, eCRFs, study manuals, and other study documents as requested by Clinical Trial Manager
• Tracks utilization of visits against the budget in conjunction with the study Project Manager/Clinical Trial Manager
• Develops Monitoring tools, Source Document Templates, and trip report annotations with review from the CRA Manager
• Arranging on-site visits and logistics
• Providing microbiology lab support to clinical programs
• Supporting Product Development Lab with In House Clinical Study (ICS) screening and verification testing during development
• Conducting study site feasibility assessments and qualification visits
• Managing and coordinating cross-functional project teams
• Serving as the primary project contact with the Sponsor (Customer)
• Monitoring team performance against contract, customer expectations, and project baselines
• Excellent knowledge of Good Clinical Practice (GCP) and also good working knowledge of conducting clinical trials in general
• Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
• Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
• Project management experience including the ability to prioritize, plan & evaluate deliverables; is well organized and structured, strong attention to detail
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Demonstrated ability to attain and maintain a working knowledge of GCPs and applicable SOPs
• Comfortable with technology and ability to learn new systems quickly
• Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures
• Attention to detail and the ability to prioritize. Strong organizational, planning and follow-through skills
• Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology

15 Clinical Research Associate resume templates

Read our complete resume writing guides

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• Prior Oncology experience
• Strong experience with EDC systems experience
• Able to demonstrate the critical elements of GCPs and federal regulations as it relates to clinical monitoring, IRB and Investigator responsibilities
• CCRA certification

Senior Clinical Research Associate Resume Examples & Samples

• At least 6 years of experience in clinical research
• Bachelor's Degree or higher, scientific discipline is preferred
• Thorough understanding of drug development
• 4-6 years industry experience, including a minimum 4 years clinical research experience
• Competent in the skills for the CRA II
• Experience in line management and/or mentoring of CR Assistants and CRAs
• Contributes in process improvement teams
• Understanding of the clinical development plan and how the individual
• Bachelor’s degree in biological science preferred
• Combination of educational and work experience providing competencies to perform the required accountabilities specific to position
• 3-5 years of CRA experience
• IVD experience is preferred
• Operational expertise
• Experienced in presenting study-related material
• Experienced in writing professional emails to both internal and external customers
• Oncology clinical trial experience highly preferred
• Laboratory/Med Tech background highly desirable
• Bachelor's or Masters in Biology, Chemistry, Molecular Biology or related discipline
• Global study experience/experience managing sites located in Europe/Asia
• Ability to work in a team situation
• Budget and contract development
• Ability to solve problems in a detailed, comprehensive manner with demonstrated urgency and energy to handle problems
• Must meet timelines and manage sites
• MSWord, Excel and PowerPoint skills are required
• Experience developing professional presentations and presenting to investigational sites and management

Clinical Research Associate Resume Examples & Samples

• Bachelor’s degree in Biology or related discipline
• 1+ years of experience within the biotechnology or pharmaceutical industry; drug development experience preferred
• Working knowledge of good clinical practices (GCP)
• Proficiency in Microsoft Office Suite
• Bachelor’s degree in a science-related discipline and/or Registered Nurse licensure required
• 2+ years as a clinical research monitor; dermatology experience preferred
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated understanding of Good Clinical Practices and Standard Operating Procedures
• Flexibility to travel domestically up to 60-80% as required
• Bachelor’s degree in a scientific discipline and/or certification in a related allied health profession (e.g., nursing certification, medical or laboratory technology)
• 4+ years of clinical research monitoring experience; 3+ years of oncology experience preferred
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
• Understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• 3+ years of experience as Clinical Research Associate; experience in early development trials preferred
• Bachelor’s degree in Biology, Pharmacy, or similar health-related discipline
• Strong regulatory knowledge (including GCP)
• Flexibility to travel up to 65% domestically
• 4+ years of relevant industry experience in a CRO, pharmaceutical company or biotechnology company
• Comprehensive understanding of all aspects of clinical trial documentation, including Clinical Study Report compilation
• Strong familiarity with industry standards as applied to ICH guidelines, GCP, and the CFR
• Working knowledge of clinical monitoring responsibilities and procedures
• 3+ years of Clinical Research (CRA) and/or Clinical Research Management experience with demonstrated experience in multi-national and/or multi-site clinical studies; 3+ years of experience working as a Clinical Trial Coordinator as part of a research team in a Hospital
• Experience with ultrasound contrast agents
• Working knowledge of GCPs, CFR, and ICH guidelines
• Experience in diagnostic imaging field
• 5+ years of experience in Pharmaceutical Clinical Research
• Associate's Degree in a Scientific / Healthcare field
• Extensive knowledge of ICH/GCP guidelines and regulatory requirements
• Respiratory experience
• Partners with CAPMs and project team members to perform initial contact with potential investigators and participates in the assessment and selection of qualified investigators for inclusion in research
• Performs Qualification, Initiation, Monitoring,
• Works with research site personnel to ensure all research activities are run compliantly and according to protocol
• Perform comprehensive site management activities. Provide high-level consultative services to site personnel by coordinating and disseminating all pertinent data regarding study protocols, Case Report Forms, and GCP/applicable regulatory guidelines. Help to define quality standards within the project team
• Reviews study documentation such as protocols, informed consents, amendments, case report forms and study reports
• Reviews ethics committee reports
• Ensures compliant recording and reporting of
• Bachelor’s degree (or internationally recognized equivalent) in a life sciences related field or R.N. with a minimum of 2 years experience with clinical research, OR minimum of 6 years progressive experience with clinical research
• Clinical Research experience such as: study site research coordination or management; sponsor-level clinical research project team experience. Other experience may include investigator qualifications; study monitoring; Clinical QA Auditing and/or Clinical Data Management within the pharmaceutical or medical device industry. (Medical Device research preferred.)
• Good collaborative oral and written communication skills, with ability to relay pertinent information to site personnel and study teams
• Strong team skills with ability to work effectively with GEHC and research site personnel
• Ability to travel up to 70% of time for job related responsibilities
• Computer literate; Proficient Microsoft Office skills including Word, Excel, and Outlook. Ability to adapt to multiple technology platforms/systems
• Experience leading/supervising clinical research projects, including managing teams and the ability to prioritize, plan, delegate & evaluate deliverables; is well organized and structured, strong attention to detail
• Clinical trial professional certification, e.g. CCRP, CCRA or CCRN
• Experience interfacing with Regulatory Agencies such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc
• Knowledge of Quality Management Systems
• Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment
• Demonstrated ability to work well
• Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
• Manage and have accountability for clinical operations activities for all clinical trials for Client and potentially full project management responsibility for 1 or more smaller clinical trials including but not limited to
• Protocol authoring and CRF design/development
• Site selection and start up activities
• Management of clinical monitoring activities
• Clinical document authoring including informed consent forms, monitoring tools, CRF completion instructions, investigator brochures, etc
• Additional responsibilities include
• Act as the primary contact person for the clinical sites and vendors
• Manage study CRAs and monitoring activities (including co-monitoring)
• Lead feasibility activities as needed
• Assist with outsourcing services to vendors including preparation of request for proposals, analytical review and feedback on vendor proposals and statements of work and direct input into the recruitment and selection of vendors
• Manage clinical site contracts and payments
• Manage central IRB or Ethics Committee approvals at sites for trials
• Liaise with clinical data management lead and/or the data management vendor, if applicable, to ensure quality data is produced for each clinical trial in accordance with the protocol, statistical analysis plan and ICH/GCP and other regulatory requirements
• Responsible for monitoring and tracking clinical drug supplies at the study sites
• Responsible for evaluating clinical site and vendor performance
• Assist with regulatory IND/NDA submissions as needed Participate in clinical audits, lead the effort to track and collect missing or outdated documents or follow up on outcome of clinical audits
• Ensure understanding of appropriate Client SOPs, ICH-GCP guidelines
• Ensure studies and clinical project deliverables are performed with quality standards and in accordance with ICH/GCP and other regulatory requirements
• Additional duties as assigned by Director, Clinical Projects or VP R&
• Strong understanding of the clinical trials process and regulatory requirements
• Proven track record of successfully managing clinical trial activities in a quality manner and within the projected timeline and budget
• Able to lead and work within teams and networks with internal and external team members promoting collaboration, effective work procedures and effective communication among the team
• Demonstrate conceptual, analytical and strategic thinking
• Demonstrate effective problem solving
• Able to understand the impact of technology on studies and to use and develop computer skills
• Current GCP training
• Previous site monitoring experience
• CRA or project management assistance in a pharm/biotech company
• Expert in MS Word, Excel, and PowerPoint required, MS Project experience a plus
• Possess excellent English language written and verbal communication skills
• Strong organizing and planning skills to work independently with efficiency and accuracy
• Ability to travel up to 15%
• Clinical Research responsibility for marketed products, product modifications and/or assigned New Product Introduction (NPI)
• Coordination of safety plans with Corporate Toxicology and scheduling of biocompatibility testing
• Conduct study site feasibility assessments and qualification visits
• Bachelor's degree or higher in a Science or Engineering discipline from an accredited institution
• Minimum of two (2) years clinical research experience
• Bachelor’s degree or higher in Science, Nursing, Clinical Research or related discipline from an accredited institution
• Certifications that include
• Association of Clinical Research Professionals (ACRP, Certified Clinical Research Associate (CCRA) and/or
• Society of Clinical Research Professionals (SOCRA), Clinical Research Professional (CRP)
• Experience in one or more of the following areas: vascular access research, wound care research and/or skin research
• Experience and knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and Food and Drug Administration (FDA) guidelines
• Knowledge and experience with regulatory function
• Experience in new product development programs
• Completion of an allied health degree in clinical research. Associates degree in Clinical Trials Research related curriculum plus a minimum of eight years’ research experience (oncology preferred) or
• Completion of a bachelor's degree plus a minimum of three years closely related research experience (oncology preferred) or
• Completion of a master's degree in a health related field with four years directly related clinical trials research experience
• Certification/license to practice as a Registered Nurse in North Carolina preferred. If not licensed, must be eligible for licensure/certification, other certifications as appropriate
• Monitoring experience
• Knowledge of the ICH guidelines, Good Clinical Practice (GCP ) DHHS, and FDA regulations
• Experience in clinical research and regulatory processes and functions required
• Experience in oncology preferred
• Highly organized with attention to detail and knowledge of scientific, medical, and regulatory terms
• Computer literacy, particularly in report design
• A person with research experience at Duke Medicine or another academic-based health care delivery system with knowledge of clinical practice and research standards in a network setting
• Clinical experience including but not limited to Nursing/patient care experience
• Clinical Research Background*
• Clinical Trials Monitoring Background*
• Patient care experience*
• = strongly preferred
• Oversee and review routine and moderately complex site activities, withminimal tono guidance,through monitoring activities, including on-site visits and/or in-houseassessments, includingtelephone contact, and other technologies according to thetrial-specific monitoring plan to assessprotocol, regulatory, and SOP compliance with some guidance from anexperiencedCRA or aclinicaltrial lead
• Completion of an allied health degree (e.g., Respiratory Therapy,Radiologic Technology, Licensed Practical Nurse) or Associates degree inClinical Trials Research related curriculum plus a minimum offour yearshealthcare experience; or
• Completion of a master's degree in Public Health,., HealthAdministration or a related area with. one year directly relatedclinical trials research experience; or
• Completion of a bachelor's degree plus a Minimum of two yearsdirectly related experience in clinical trials research; or4. Completion of a bachelor's degree plus a minimum of three yearsclosely related research experience.**State of North Carolina license may be required.**
• Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of four years healthcare experience; or
• Completion of a master's degree in Public Health,., Health Administration or a related area with. one year directly related clinical trials research experience; or
• Completion of a bachelor's degree plus a Minimum of two years directly related experience in clinical trials research; or
• Completion of a bachelor's degree plus a minimum of three years closely related research experience
• Ensure compliance/closure of Regulatory and Quality requirements before approving Design Outputs/Program Deliverables
• Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
• Masters degree in a science related field with a minimum of 3 years experience with clinical trials management within the healthcare industry or Bachelors degree with 4 years experience in monitoring clinical trials
• Excellent prior knowledge of all aspects of the clinical trial process including planning, execution and reporting/publication of results
• Proven communication skills, both written and verbal, at all levels of an organization
• Must be willing to travel as required
• Must be legally authorized to work in the United States full-time
• Must be willing to work in our [city, state] facility full-time
• Must submit application for employment through gecareers.com (or COS if internal) to be considered
• Must be willing to take a drug test as part of the selection process
• Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background
• Well organized and structured, attention to detail
• Ability to work independently and systematically
• Diplomatic, cooperative teamworker
• Designs, plans, conducts, and monitors clinical studies
• Prepares clinical reports for inclusion in regulatory submissions (e.g., CE Mark, 510K) and to support clinical claims
• Monitors clinical study compliance
• Interfaces with investigators, ethics committees and company personnel
• Plans and conducts clinical investigator meetings
• Works to ensure rapid and timely approval of products and support of marketing claims
• Manages CROs
• Manages Clinical study budgets
• Negotiates Clinical Contracts
• Expected to train and mentor others
• Serve in a project leadership role
• Knowledge of relevant medical device regulatory requirements (e.g. 510k, PMA, CE)
• Technical knowledge and skills in clinical trial management for relevant products
• Works independently on routine tasks
• Great level of experience in the Clinical Research field
• Relevant Degree
• Understanding of GCP
• Understanding of Clinical Trial Management
• Understanding of Diabetes (desirable)
• Understanding of Medical Device Regulations (Desirable)
• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Unique in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right
• Ensures monitoring, monitoring report review/finalization, event reporting and all other monitoring commitments are performed in accordance with the study monitoring plan
• Manages assigned clinical sites, partnering with field monitors and site staff to identify and escalate or resolve compliance issues, and escalation of site questions or needs
• Participates in site start up activities as assigned
• Supervises screening & enrollment at assigned clinical sites
• Routinely reviews site compliance data and works to identify compliance risks and issues
• Partners with field staff to develop a CAP to address non-compliance issues as appropriate
• Manages the completion of assigned project specific deliverables
• Participate in site close-out activities for assigned clinical sites
• Partners with colleagues to ensure assigned sites are audit ready at all times
• Conducts a thorough comparison (monitor) of case report forms against medical records on complex trials at multiple sites
• Addresses non-compliance issues and trends at investigative site; develops, documents and implements a CAP as necessary
• Conducts qualifications, initiation, interim and close out visits. Ensures all appropriate site staff are trained, have access to required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements
• Participates as an extended team member of the clinical study team including: participating in study-specific meetings, teleconferences and investigator meetings
• Conducts device accountability at clinical sites
• Conducts study specific training for new study coordinators
• Ensures that all adverse events are identified and clearly documented during visits
• Serves as a mentor and trainer of junior Field CRA staff
• Identifies and Reports complaints
• Identifies and ensures communication of the need for corrective action at clinical sites. Collaborates with colleagues and clinical sites to develop and execute corrective action plans
• Ensures training is completed per the required timelines and project needs
• Identifies process improvement opportunities. Independently proposes solutions/plans
• Tracks internal process metrics data to measure performance
• Bachelor’s Degree in Science or Healthcare Related Field, or an equivalent combination of experience and education
• 3+ years experience in clinical/scientific research, medical device experience
• CRM Electrophysiology device study experience preferred
• Candidate needs to reside in location within reasonable travel distance to the St Louis, MO region
• Must be able to travel 50-75%
• The Clinical Research Associate (CRA) monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols. Reviews regulatory documents as required and prepares site visit reports
• May be responsible for multiple projects and must work both independently and in a team environment
• Participate in the study development and start-up process including reviewing protocols, designing and/or reviewing Case Report Forms (CRF), preparing Informed Consent Forms (ICF’s), developing study documents, organizing and presenting at investigator meetings, working with management on a monitoring strategy, and/or developing project-specific CRA training. S/he may participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed
• S/he may provide a benchmark of monitoring competence to inexperienced/less experienced colleagues
• Prepares clinical documents, business correspondence, and procedural manuals
• Maintain systems and process necessary to report trial status and activities; and to help ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget
• Depending upon the level of experience, may become involved, when required, in other areas of study management and staff training and contributes to the review of sponsor/client’s and/or FHI 360’s systems and procedures as appropriate
• Bachelor's Degree or its International Equivalent - Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field; Master's degree preferred
• Must currently be located in Francophone West Africa
• French fluency required
• Must have at least 1 year of clinical research experience
• Advanced degree or its international equivalent preferred
• Supervisory or management experience required
• Global clinical research work required
• Spanish and/or French language proficiency strongly preferred
• The Clinical Research Associate (CRA)/Zonal Team Leader, monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols
• Reviews regulatory documents as required and prepares site visit reports
• Participate in the study development and start-up process including reviewing protocols, designing and/or reviewing Case Report Forms (CRF), preparing Informed Consent Forms (ICF’s), developing study documents, organizing and presenting at investigator meetings, working with management on a monitoring strategy, and/or developing project-specific CRA training
• S/he may participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed
• S/he may provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Prepares clinical documents, business correspondence, and procedural manuals. Maintain systems and process necessary to report trial status and activities; and to help ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget. Depending upon the level of experience, may become involved, when required, in other areas of study management and staff training and contributes to the review of sponsor/client’s and/or FHI 360’s systems and procedures as appropriate
• Educate patients about clinical research protocols, study requirements and expectations
• Adhere to legal, professional and ethical codes with respect to confidentiality and privacy
• Collaborate with other members of the research team to ensure consistent practice in patient care management
• Monitor on-site study sites to meet with, assist and consult with study investigators
• Recruit and schedule all study site personnel as required
• Track the expenditures for all study-related activities, including supplies and equipment
• Create study documents, including protocols and amendments thereof, consent forms, data collections forms
• Provide inputs to final reports that document the research findings for human use protocols including, but not limited to those listed above
• 2-4 years of related experience in scientific research and analysis
• Familiarity with clinical research methodology is required
• 1 or more years of experience in direct provision of vestibular testing; experience with equipment such as NeuroCom and Rotary Chair, as well as vestibular rehabilitation techniques
• Prior experience with participant and/or patient interaction in a clinical setting
• Ability to follow detailed instructions and standard operating procedures
• Excellent communication skills (verbal and written) and analytical skills required
• S/he must adhere to legal, professional and ethical codes with respect to confidentiality and privacy
• Possession of a Bachelor’s degree from an accredited college/university in a field related to biomedical research, clinical trials and/or health or four (4) years related experience in lieu of degree
• In addition to education requirements, a minimum of two (2) years of progressively responsible experience in biomedical research including a minimum of one (1) year directly related to overseeing multiple concurrent trials and monitoring studies at clinical sites
• Minimum one (1) year of on-site clinical research monitoring of studies for a sponsor or CRO
• Ability to work in a clinical research setting, both independently and within a team
• Ability to prioritize multiple tasks/projects and accomplish goals in expected timelines
• Ability to communicate effectively, verbally and in writing, with non-technical and technical staff
• Knowledge of clinical trial fieldwork, monitoring concepts and practices, FDA regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCPs)
• Must be detail-oriented with strong organizational skills
• Knowledge of TrackWise or similar Clinical Trials Management Tracking Systems
• Ability to travel up to 60% locally, domestically and possibly internationally
• ACRP Certified CRA or SOCRA Certified Clinical Research Professional
• Infectious diseases/influenza experience
• Knowledge of Department of Health and Human Service (DHHS) regulations
• Experience with the development of CRFs, eCRFs, manual of operations and study monitoring plans
• Experience with database applications
• Knowledge of conducting federally funded studies
• Ability to read and/or speak French or Spanish
• A minimum of a Bachelor’s Degree and/or RN Degree is required
• A minimum of 3 years clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, or contract research organization is required
• Must have in depth knowledge of the Code of Federal Regulations related to clinical research, ICH GCP guideline and other applicable regulations and practices is required
• Working knowledge, understanding and application of principles, concepts and practices of clinical research, experimental design and statistical analysis is required
• Communication - Maintains timely and effective communication among team members and site staff. Routinely anticipates/identifies potential issues and implements corrective actions independently. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution
• Monitoring - Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly reviews the status of the contents of the site regulatory binder; exhibits effective time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits
• Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Proficient with multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed
• Reporting and Tracking - Completes and submits reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit
• Administrative - Prepares for and attends Investigator meetings. May attend Customer and Business Development meetings. May present materials, as requested. Assists with the preparation of study start-up materials and tools, as requested. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring, and/or training plans
• Independent clinical monitoring experience
• Extensive understanding of SOPs, WI, FDA, and local regulations as well as ICH GCP guidelines
• Effective command of written and spoken English language
• Communication - Maintains timely and effective communication among team members and site staff. Anticipates/indentifies potential issues
• Regulatory Documentation - Assures compliance with local regulations, Code of Federal Regulations. (CFR)/International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor. SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines. and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested; may require guidance to. respond to findings. May be responsible for assisting with the submission of regulatory packages to ethics committees and/or competent authorities
• Monitoring - Assumes responsibility for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements;assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; and regularly reviews the status of the contents within the site regulatory binder
• Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Utilizes multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed
• Reporting and Tracking - Completes and submits visit reports according to SOP/Works Instructions (WI) requirements. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit
• BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience. Previous clinical or related research experience preferred. Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines; basic knowledge of applicable therapeutic standards. Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment. Native fluency in Japanese language (speaking, reading and writing) and able to handle business level English
• Ability to travel approximately 50% is required
• 3-4 years experience as a CRA in biotechnology, pharmaceutical industry or CRO
• Experience in effectively managing multiple tasks and projects
• Ability to self motivate and work independently to meet timelines
• Delegates work appropriately
• Independently develops study documents and processes
• Demonstrated ability to monitor all visit types independently
• Understands the needs of stakeholders and able to develop action plans
• Discerns urgency of issues and takes appropriate action
• Good working knowledge of ICH & GCP
• Responsible for the conduct and management of post marketing commitment studies, focusing in the areas of protocol development, study planning and implementation, site monitoring and management, enrollment and data quality
• Responsible for feasibility assessments for new studies
• Manages TMF contents and responsible for TMF reconciliation
• Responsible for the preparation of study documents (i.e., consent forms, site instructions, etc.)
• Responsible for the preparation of study training and investigator meeting materials and presents at study training workshops and investigator meetings
• Responsible for the development and preparation of study startup, maintenance, and closeout activities, including monitoring plan
• Responsible for the adherence to timelines, study quality and SOPs for assigned studies
• Coordinate and complete all operational activities required for the registry startup, ongoing maintenance, and closeout of Medical Affairs (MAF) registry programs
• Monitoring of registry programs at sites according to the monitoring plan
• Participate in the selection of CROs and other vendors as needed
• Responsible for the preparing reports that outline registry progress for both internal and external customers
• Partner with the MAF team members to anticipate/identify potential problems with registry activities and develop and implement corrective actions to ensure success with these activities
• Guidance of registry specialist activities supporting MAF programs
• Assist in the planning and execution of clinical studies ensuring that deliverables are completed on time and within budget
• Create and manage reports that detail the clinical study progress such as subject screening and enrollment, data collection, documentation of adverse events, and payments
• Assist with the development and management of study-related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools
• Participate in site qualification and site initiation process, including review of required site documentation
• Maintain current working knowledge of the disease state & product
• Assist in training of investigators and coordinators
• Assist with the development and implementation of site corrective actions as needed to address any noncompliance issues
• Help with development and oversight of clinical database for the trial
• May assist clinical manager by providing input to sections of clinical reports for FDA (510(K), IDE/PMA) and abstracts/manuscripts
• Management of investigative sites to ensure sponsor support of trial activities and oversight of site compliance
• Coordinate and conduct monitoring visits at participating centers to ensure compliance to the investigational plans, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports
• Participate in regular project team meetings
• Minimum of 5+ years experience directly supporting Clinical Research
• Strong computer skills with a proficiency with MS Windows based applications
• Strong organizational skills and able to manage multiple tasks
• BS / BA in a related scientific or clinical field required
• Minimum of 3 years related medical device / pharmaceutical field monitoring required
• Field-based position and ability and willingness to travel up to 75%
• Excellent interpersonal, problem solving and communication skills
• Excellent follow-through capability
• Self-motivated, attention to detail and organizational skills
• Experience with various computer systems / applications and clinical trial management systems an willingness to learn new systems / databases
• Ability to autonomously prioritize workload to meet study timelines while monitoring multiple protocols
• Perform monitoring visits: Qualify potential investigative site, Train and initiate investigative sites, Conduct routine monitoring visits and close out visits
• Complete on-time and thorough monitoring trip reports Review case report forms to ensure data compliance
• Account for investigational devices ensuring the devices are available, stored appropriately, and accurately inventoried and documented
• Verify appropriate reporting and documentation of adverse events and protocol deviations per protocol requirements
• Ensure site regulatory binder is current
• Manage investigative sites from study start up through close out
• Provide support to the investigator evaluation and recruitment process
• Create telephone scripts, feasibility questionnaires, and / or other related assessment tools for use in site evaluation
• Assist in the collection of initial regulatory documentation
• Assist in the preparation of study binders, manuals, or other site specific tools
• Assist in the review of draft protocols, CRFs, and CRF Completion Instructions
• Assists in the creation and / or revision of Clinical Affairs Standards and Work Instructions
• Develop study specific monitoring tools
• Perform study tracking activities as requested
• Assist in Development of Clinical Monitoring Plan and / or other study related documents
• Contribute to internal CRA meetings
• Proactively identify issues which may interfere with study progress and implement strategies to resolve issues
• BS / BA in a related scientific area Basic knowledge of clinical trial methodology relating to the monitoring of clinical trials, GCP, FDA, and / or country specific regulatory environment Minimum of 3-6 years of field monitoring experience Medical device experience preferred, but not required Proficient in MS Office Suite of products Experience with Clinical Trial Management System preferred Experience with EDC system preferred Excellent interpersonal and communication skills
• Conduct training of investigators and coordinators
• Coordinate and conduct monitoring visits at investigative sites to ensure compliance to the investigational plans, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports
• Verify appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements
• Assist in planning, preparing, and presenting materials for investigator and coordinator meetings
• Assist with vendor management to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
• Develop and maintain current working knowledge of the disease state & product
• BA/BS or equivalent medical / industry experience
• Minimum of 2+ years experience directly supporting Clinical Research
• Strong working knowledge of Good Clinical Practices (GCP), FDA regulations, ISO 14155, and current industry practices related to the conduct of clinical trials
• Previous experience with peripheral vascular devices preferred
• Previous experience with EDC systems preferred
• Ability to work effectively on cross-functional teams preferred
• Valid driver’s license required
• Able to travel 20% on average and up to 50% during peak periods
• Assist clinical team with study start-up activities
• Thorough understanding of operational aspects of clinical research and regulatory requirements
• Good interpersonal, problem solving and communication skills
• Self-motivated, attention to detail and organizational skill
• Experience with various computer systems / applications and clinical trial management systems; willingness to learn new systems / databases
• BS/ BA or higher in a related scientific area preferred; a minimum of an RN is required
• Minimum of 3 years related device / pharmaceutical field monitoring
• Serve as a leader and mentor to other CRAs in all aspects of the CRA role. May represent Regional Associate Directors and region at management meetings or other meetings as assigned and participate in decisions made at assigned meetings (e.g. site selection, site issue resolution). May interview prospective CRA candidates and assist with performance evaluation and management of CRAs
• Ensure the site Investigator Folder is up to date and mirrors the Novartis TMF. Responsible for collecting regulatory documents from site and filing in the Novartis Trial Master File. Prepare and collect study site documents
• Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF (or eCRF) completion, SAE reporting, GCP, and possibly the drug mechanism
• Responsible for utilizing and updating electronic systems to perform job functions (e.g. Outlook, WinFx, ClinTransfer, IMPACT, IWS, eTrial Master File webEDI, I.MAN, STARS, Vantage, SSU Database, Investigator Portal, LMS, ESOPs, iLearn, Expense reimbursement, CWT Horizon, Metrixx, Timecard, PMP, multiple eCRF applications). Serve as a reference to other CRAs on electronic systems. May be responsible for assisting with the evaluation, design and implementation of new systems
• Ensure that study milestones are met as planned (i.e. database analyses, study startup, recruitment, closeout, etc.)
• Prepare study monitoring reports, per Standard Operation Procedures (SOPs) and applicable regulations. May review and approve monitoring reports of junior CRAs as assigned
• Manage data query resolution process with sites and track status updates (i.e. IWS)
• Perform Site Closeout activities per SOPs and applicable regulations
• Travel domestically (and possibly internationally) as needed to study sites and for training and meetings. A minimum of 50% overnight travel may be required
• Attend and participate in disease indication and project specific training and general CRA training as required
• Assist in and participate, plan, and lead study training meetings (e.g., investigator/coordinator meetings)
• Assist study site staff, investigators, sales representatives, and other staff members regarding investigational products and protocol
• Cardiovascular device trials
• Cath lab, operating room and/or intensive care unit familiarity
• Effective strategic, critical thinking, problem solving skills
• Knowledge of computerized databases for the maintenance of scientific data
• Ensure that all data and data collection from clinical research are handled according to applicable regulations and guidelines
• Maintain dedicated investigation files to audit and inspection standards
• Write protocols, amendments, case record forms, clinical reports and other documents relevant for dedicated clinical investigations. This includes ensuring the submission processes (CA + EC/IRB)
• Ensure that monitoring is performed as planned including start-up and close-out meetings securing a quick start, good quality and adherence to timelines
• Accountable for the handling of contracts and agreements with investigators, CROs, hospitals and universities
• Accountable for the preparation, updates and adherence to budget including invoices/payment in dedicated investigations
• Participate actively in preparing posters, abstracts and manuscripts
• Coordinate with internal and external stakeholders to bring the investigation from "A to Z" according to plan and budget
• Prepare and conduct or ensure relevant training for involved people including investigators, nurses, CRAs and other persons within Dentsply Sirona
• Take part and initiate processes, procedures etc. in order to further develop the skills and capacity of the clinical research team
• 3+ years clinical study experience in medical device of pharmaceutical field
• Working knowledge of Good Clinical Practice (GCP) guidelines
• Proficient in MS Word, Excel, PowerPoint
• 6 months + experience with Clinical monitoring procedures
• Ability to follow U.S. FDA and international regulations pertaining to medical devices and industry guidelines related to regulatory submissions, institutional review boards, clinical investigations, monitoring procedures and medical device reporting
• Ability to travel as needed (25%)
• Prepare and execute large scale (100 subject plus) external R&D verification trials –documentation, site training, IRB submission
• Serve as primary contact for external sites and CRO for all study related questions
• Monitor EDC production site for open queries and assist external sites in closing them with guidance from EDC programmer
• Prepare and organize study materials, such as CRF’s and Informed Consent documents
• Prepare and present training material for external sites
• Create and submit IRB submissions and close out reports
• Review and understand study protocol and ensure accurate execution of study procedure
• Recruit, screen and schedule study patients via e-mail and phone
• Directly interact with patients in the exam room: obtain informed consent, educate patient on study procedure
• Assist as necessary in study methodology
• Collect and enter study data on electronic data capture system and on paper
• Compile and validate all study data
• Reconcile study materials
• Ensure accurate documentation following GCP and GDP
• Maintain calibration, organization and cleanliness of the research clinic and exam rooms
• Conduct monthly payroll run with EDC programmer and create purchase orders when needed
• Perform monthly reclass report and quarterly Sunshine Act report
• Study tracking and monthly reporting
• Update and maintain patient database
• Create and update SOP’s
• Update and maintain research clinic website
• Organize efforts and initiatives to attract new patients
• Associate’s Degree /or Equivalent Education/Training
• PC Skills (Microsoft Office Proficiency in the following: Outlook, Word, Excel and Internet Explorer)
• Customer service orientedPreferred Qualifications
• Microsoft Office Proficiency Access and PowerPoint
• Experience in a Clinical research-focused environment
• Health-related training and/or experience
• Administrative support background
• Acquires a basic understanding of the principles of the assay and/or instrument and “hands-on” knowledge and skills in performing assigned assays or operating instruments
• Serves as a consultant in a select area of expertise
• Obtains and reviews all required essential documents necessary for study initiation
• Conducts pre-study; initiation; interim; and close-out monitoring site visits and completes site visit reports
• Maintains accurate and timely sponsor/site correspondence and communication
• Prepares and presents project progress reports to keep management and team informed
• Prepares standard the clinical sections of regulatory submissions and international registration packages
• Coordinates preparation of responses to regulatory agencies’ questions regarding the clinical study
• Prepares publications; abstracts; or presentations for professional meetings with minimal assistance
• May advises and trains newly hired CRAs and direct others in the completion of tasks and projects
• Maintains professional; product; and market expertise via independent reading; networking; and training
• Volunteers for task forces; manages projects; or serves as a group leader. Encourages collaborative behavior; delegates effectively; and empowers others to take action. Gives effective feedback. Acts with fairness. Actions and words are congruent
• Be primary point of contact for sites
• Build and maintain relationship with sites
• Monitor sites (Initiation Visits, Routine Visits, Close Out Visits, etc)
• Produce monitoring reports within SOP and monitoring plan timelines
• Coach investigators to be compliant with GCPs and the protocol
• Talk to site staff about site recruitment
• Ensure sufficient drug supply on site and reconcile drug on site
• Ensure high quality data and conduct at sites
• Identify and escalate issues or concerns to the internal Amicus team
• Identify, analyze problems and trends; provide and recommend solutions across studies
• Acts as liaison between CRO CRAs, Field Based CRAs and the PM
• Accountable for reviewing and approving all trip reports for assigned studies
• Develop training tools and training materials in support of the project
• Develop study tools for sites and CRA use
• Ensure that monitoring visits are performed in accordance with protocol/SOP monitoring plan requirements and that these are tracked, including report status and sign off
• Accountable for the quality of the trip report content
• Facilitate the review and provide input to the Monitoring Guidelines
• Co-monitor with 3rd party CRAs as needed
• Lead the day to day support of study operations including tracking and creating overviews of subject, site, study status, milestones and performing quality check activities across components of the clinical study
• Conduct and/or oversee clinical monitoring (site qualification, site initiation, interim monitoring, study closeout visits) activities to assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. May included monitoring visit report review and/or participating in co-monitoring visits
• Assist in study set-up including but not limited to eCRF design, protocol preparation, informed consents, investigator selection, systems (e.g., CTMS), study related operational manuals, training materials, and various study plans (e.g., visit logs, monitoring plan, etc.)
• Process and track clinical trial materials requests, study related supply requests, safety letters, vendor and investigator payments and other study related activities as needed
• Collaborate with cross-function study team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and AIRM SOPs
• Ensure complete and timely collection and archiving of TMF documents of assigned studies or program, including oversight and. or submission of regulatory documents to the TMF and ongoing document reconciliation
• Assist in maintaining accurate and up to date study information within CTMS and other relevant tracking systems
• Effectively communicate with study team members and work closely with Lead Study Manager to address challenges
• May participate in process improvement and quality-related initiatives associated with study execution and deliverables
• Responsible for complying with regulations and guidelines and ensuring adherence to these during study conduct
• Travel Required: up to 25%
• BA/BS with 4-8 years clinical research experience, or MA/MS with 2-6 years clinical research experience
• Ability to work independently under general direction in a fast-paced environment
• Minimum of 2 years prior clinical monitoring experience
• Must have excellent interpersonal, written, verbal, presentation, administrative and computer skills
• Moderate (25%) travel required
• Serve as clinical contact for a study including CROs/vendors, Investigators and study coordinators
• Support the Clinical Study Manager and/or Director of Clinical Research with vendor selection and vendor management, including the Contract Research Organization (“CRO”) and other clinical study vendors (Central Lab, IVRS, Scale Management, etc.)
• In conjunction with the Clinical Study Manager and/or Director of Clinical Research, manage site selection process for clinical studies
• Assist and support development and review of clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Case Report Forms, Source Documents, Monitoring Plan, Data Management Plan, Project Management Plan, etc.)
• May accompany CRO/CRA’s to monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCP’s), SOP’s and study protocols
• Assist in management and oversight of CRO in terms of the approved study budget and compliance to SOPs, and CRO personnel in terms of performance including selection and termination
• Order and coordinate study supplies for clinical studies
• Assist in review of vendor contracts and budgets
• Assist and support data validation and data clean procedures
• Assure regulatory compliance of investigational sites with SOP's and FDA and ICH
• Minimum of 8+ years of experience in the pharmaceutical / biotechnology industry performing as a Clinical Research Associate with a combination of experience in in-house study management from study start-up to database lock, as well as, clinical site monitoring experience
• Strong, relevant therapeutic experience in pharmaceutical/biotechnology clinical trials
• Experience in selection and management of vendors/CROs (Central Lab, IVRS, EDC); previous experience as a Lead CRA or Clinical Team Lead is highly preferred
• Experience in leading and working within functional teams
• Ability to handle and prioritize multiple studies and projects
• Ability to work effectively in a team/matrix environment
• Ability to understand technical, scientific and medical information
• Demonstrated strengths in planning, organizational, project management, analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills
• Ability to travel up to 25% travel including ground and air
• 7+ years of pharmaceutical development experience with at least 5 years of advanced site monitoring/management in complex small molecule and biologic trials in a wide array of diseases (oncology, transplant, HIV, etc.) across the development spectrum (phases I-IV, DMD, CRO partnership)
• Mastery of all site monitoring visits (pre-post) while also understanding that site personnel may require support until lock
• Extensive knowledge of ICH/FDA guidelines and thorough knowledge of global Health Authority (e.g., EMA, MHRA) regulations impacting activities in the US
• Thorough knowledge, experience preferred, of industry trends (Risk Based Monitoring, Remote Monitoring, Remote Source Data Verification/Review, etc.)
• Exhibits a high level of flexibility and sets an example for adaptability for changing priorities and processes
• Employs strong fiscal management of departmental budget by independently managing travel and functional expenses
• Demonstrates strong project management skills when engaging with stakeholders to ensure efficient management of timelines, resources, encountered challenges and stakeholders
• Serves a role model for department through active planning, participation and representation on various projects, initiatives involving a wide breadth of internal and external stakeholders
• Ability to manage successfully with designated book of work, adjust accordingly for risk based monitoring practices using critical thinking skills, and prioritize actionable items as necessary
• Investigative Site Monitoring - Demonstrate a commitment to quality in all aspects of monitoring; adhere to study monitoring plans; support site identification by conducting feasibility studies as needed; conduct Pre-study Visits for Investigative Sites; effectively facilitate/negotiate contracts for assigned sites within clinical subject budget as needed; conduct Study Initiation Visits at Investigative Sites; conduct Interim Monitoring Visits at Investigative Sites; review the investigator study file and reconcile versus the Trial Master File in compliance with GCP/ICH ; perform investigational product accountability and verify storage conditions; coordinate/organize the delivery of supplies as required; validate and track payments to assigned sites and patients travel reimbursement as needed; and conduct Close-out Visits at Investigative Sites
• Data Integrity - Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of the subjects during their participation in a study; evaluate data query trends and interact with study team in order to improve data quality; assist investigative sites to achieve timely and accurate data entry and resolution of queries; ensure timely submission and review of CRF data and query resolution according to timelines set forth in the SMP; ensure issues of data quality are escalated and resolved/followed-up with the study team and CQA, as needed
• Subject Safety - Monitor the informed consent process; perform safety reviews/SAE reconciliations; verify correct dispensing of IP to subjects; manage Investigative Sites’ adherence to GCP, ICH guidelines and local regulations
• Train and Assist Investigative Sites - Attend Investigator Meetings, contribute and present when required; train investigative site personnel in GCP/ICH and study-specific requirements and monitor that sites are conducting Celgene clinical research according to the protocol, local regulatory requirements, and other appropriate regulations; serve as liaison between Celgene and assigned sites; build effective and positive relationships with site staff at assigned sites
• Communication - Identify site issues, ensure proper escalation, if necessary, and ensure resolution/follow-up; create monitoring reports, confirmation/follow-up correspondence and telephone contacts for assigned sites; respond to audit findings if applicable; adhere to proper lines of communication within Celgene; attend and participate in study team meetings as assigned; keep information in the CTMS current; maintain calendar
• Regulatory Documentation - Compile ethics submissions dossier in consultation with the investigator; support and ensure that country specific requirements are obtained when applicable; adapt patient information and consent form to local regulatory requirements to ensure approval; review translations for ICD and study documents as needed; ensure translation and back-translation of study specific documents as required; ensure local requirements are adhered to for EC updates (annual reports, protocol amendments and study completion/termination and safety reports where applicable); maintain local document files at a country level, as needed; liaise with Regulatory Affairs department for submission and any relevant change to be reported to a Competent Authority; maintain study information in the National Trial Database where appropriate
• Development – Ensure that the medical and clinical knowledge for assigned therapeutic areas is up-to date with the support of line manager; develop and maintain a good working knowledge of relevant protocols; maintain a good working knowledge of FDA, GCP/ICH requirements and relevant regulatory requirements; mentor/coach new CRAs as needed; maintain annual qualification records
• Examples of Monitoring Lead activities as required locally- serve on study team as monitoring Lead; review RFPs regarding monitoring specifications when required; develop study monitoring plan and subsequent revisions; review, track and acknowledge monitoring visit reports; manage and track monitoring site visits to ensure quality monitoring; highlight inadequate monitoring resources; track and report critical issues to study team; participate in CRF and protocol review process; conduct CRA/FM meetings
• Others - Identify/evaluate potential investigators for future Celgene studies; participate and contribute to Clinical Research meetings, cross-functional activities and sharing best practices amongst the team as appropriate; contribute to adequate training of monitors in the study requirements; perform field assessments of Celgene and CRO CRAs, as required; develop study-specific tools for Investigative Sites and CRAs/Field Monitors; CRO monitoring oversight as required; create and review WPs and SOPs if applicable; identify study process improvements
• The contractor shall provide oversight and administrative efforts in order to efficiently and effectively monitor the clinical trial process
• The contractor shall verify and ensure that the rights and well-being of the human subjects enrolled in the clinical trials are protected and that the reported trial data are accurate, complete, and verifiable from source documents
• The contractor shall ensure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with ICH current GCP, FDA CFR, USAMRMC, OTSG-DA, and DoD, along with other applicable Sponsor and regulatory requirements, requirements of host countries and other government regulations
• The contractor shall lead the development, coordination, and implementation of monitoring and administrative strategies essential to the successful management of clinical trials research
• The contractor shall conduct site pre-qualification and initiation visits; verifying that assigned research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout trials
• The contractor shall conduct on-site clinical monitoring that includes; protocol training prior to study start, document reviewing, ensuring accurate data recording, monitoring adverse events, concomitant medications, and inter-current illnesses and verifies they are reported in accordance with the protocol on the Case Report Form (CRF), verify patient data, ensuring adherence to the clinical protocol, site and Sponsor SOPs, investigational product accountability, verification of product shipping/storage conditions, etc
• The contractor shall conduct closeout site visits, including reviewing record retention requirements, investigational product reconciliation and securing and reviewing investigator’s final report
• SCRAs must work effectively as part of an Integrated Product Team (IPT) and act as the Sponsor’s liaison to resolve site related issues quickly and effectively
• The contractor shall prepare trip reports and recommend corrective actions, where appropriate, in accordance with USAMMDA SOPs
• The contractor will maintain written or email communication as well as telephone communication with the clinical sites. Telephone communications will be documented in minutes
• The contractor shall participate in reviewing protocols, amendments, investigator brochures, Informed Consent Forms (ICFs) and CRFs and facilitate Institutional Review Board (IRB) submission, queries, and approval
• The contractor shall possess documented advanced training in GCPs as well as significant experience in clinical trial monitoring, including paper and Electronic Data Capture (EDC) studies
• SCRA positions require travel 50-65% of the year
• Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer
• Must possess documented advanced training in GCPs as well as significant experience in clinical trial monitoring, including paper and Electronic Data Capture (EDC) studies
• Possess a Bachelor's degree in Science/Health related field or equivalent experience
• A Master's degree is preferred and will equate to 1-3 years experience
• Shall possess 7-10 years in clinical trial monitoring
• Certification as a Certified Clinical Research Profession (CCRP) or Certified Clinical Research Associate (CCRA) is preferred
• SCRA positions may require travel up to 65% of the year
• Must provide capability to learn, speak, write, and interpret foreign languages as appropriate
• Must have the ability to obtain Secret Clearance
• Support Clinical Trial Managers by coordinating necessary activities required for setting up investigational sites and monitoring a clinical study, completing accurate study status reports and maintaining study documentation
• Update clinical trial management systems
• Initiates, maintains and reconciles the sponsor study files in accordance with Standard Operating Procedures (SOPs)
• Process site payments
• Collects and reviews regulatory documents from clinical sites
• Maintain tracking logs for departmental activities (i.e., training compliance, study related tasks)
• Provide quality overview and consistency check on all developed ICFs and completes the informed consent checklist
• 3 year minimum administrative experience
• 3 or more years of administrative experience in a pharmaceutical or other health related industry, previous on-site monitoring experience preferred
• Strong organization, time and self management skills
• Knowledge of ICH/GCP guidelines
• Ability to working in a team or independetly as required
• Familiarity with Clinical Trial Management Systems
• Regional location (US East Coast, Mid-West [Chicago, Atlanta, Philadelphia, New York City, Boston, Washington, DC, Charlotte)
• At least four years of experience as a Clinical Research Associate. Experience in the management of multiple sites as a Clinical Research Associate is preferred
• Excellent verbal and written communication skills, in addition to excellent organizational skills
• Ability to travel 50% within North America is required
• Monitoring: Ensures compliance of assigned sites with protocol, regulatory and overall study objectives. Confirms the qualifications of investigators, medical centers, and investigational sites throughout the conduct of a program and assesses adherence to Good Clinical Practice (GCP). Independently monitors clinical study sites: documents all findings, outcomes and agreements reached during site visits. Resolves discrepancies and ensures proper maintenance of site's documentation
• Participates in co-monitoring visits
• Participates in study meetings
• Periodically reviews adverse events reported in the study and works with Pharmacovigiliance colleagues on reconciliation of safety databases. Oversees the required communication to the investigators as per the regulatory guidelines
• Manages data discrepancies for assigned sties and coordinates the clinical monitoring activities to ensure that these discrepancies are resolved in the established timeframe for resolution
• Manages laboratory specimen collection process where applicable including interfacing with laboratory and vendors. Ensures supplies for specimen collection are adequate at the site and site staff is trained on collection and shipment process
• Identifies problems/issues and reports findings
• Minimum 1-2 years experience as a CRA or other related experience in the health care, biotechnology, diagnostics, or other relevant industry; related experience may include clinical trial assistant, project assistant, study assistant or study coordinator
• Demonstrated competence with Microsoft tools, specifically Word; Excel; PowerPoint; and Project
• Well-organized and detail oriented
• Strong oral and written communicator with ability to maintain open communication with internal employees, managers and customers as needed
• Attend meetings with CRO and/or vendors and provide input during development or UAT phases
• Assist in preparation and maintenance of ClinTrials.gov submissions
• Comply with established company policies and procedures, objectives, quality assurance program, safety, and environmental standards
• Attend seminars/conferences as required to keep up to date with clinical knowledge
• Bachelor’s degree in a clinical or health related field, in life sciences, or equivalent work experience. Prefer RN or BSN
• 3 years of onsite monitoring experience
• Experienced in oncology/immunotherapy protocols
• Strong understanding of ICH GCP Compliance
• Ability to travel 65-70% of the month
• Can conduct full range of data collection duties, including equipment setup and operations, execution of study per procedures, collect data, verify results and transfer data back to Masimo, etc
• Plan, implement and conclude clinical studies in support of project timelines/market release goals with minimal supervision; An advanced individual may conduct more complicated studies, as well as contributes to study proposals and protocols, applying principles of clinical study design and research methodology to assigned research projects
• Prepares and documents study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage and accuracy across all assigned projects
• Contribute to clinical study design, proposals, protocols, etc., understanding basic scientific content, experimental design, and analytical approaches used
• Can effectively work and communicate with investigator, staff and patients in professional, sensitive and mature manner
• Conduct site monitoring (qualification, initiation, monitoring and close out visits) to insure and document site is trained to follow study procedures per protocol
• Likewise, can monitor safety reviews and adverse event reporting for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations
• Can suggest improvements to departmental procedures relating to GCP monitoring aspects
• Can understands and operate Masimo products, data acquisition systems, following best practices for execution of study protocol and use of equipment
• Insure essential study documents are properly organized and stored as quality records
• Can conduct basic data analysis using spreadsheets, preparing basic calculations, statistics, graphs and tables
• Writes clear, succinct and detailed clinical study and technical summary reports
• Ability to travel extensively, perhaps 25-50% of the time, locally and domestically; Travel requirement is subject to change based on business needs
• Must be able to lift and carry up to 20 pounds in order to: pack, ship, move, unpack, set up and execute equipment for study at clinical site, and then repack and ship back to Masimo
• Perform special projects as requested
• Experienced with Good Clinical Practice (GCP) in conduct of clinical studies
• Excellent written and verbal communication skills essential
• Must be capable of interacting with all levels of management, coworkers, investigators and subjects
• Proficiency with Microsoft Office, computer data acquisition, data analysis, graphing and plotting results and report writing
• Ability to independently set and manage multiple priorities
• Demonstrates advanced judgment and decision making ability in the execution / oversight of clinical studies
• Ability to travel to data collection sites, local and domestic, may require up to 25-50% of time
• Ability to lift and carry up to 20 pounds
• Experience with medical devices
• Strong clinical background (e.g., respiratory therapy, nursing, pharmacology, physiology)
• Excellent knowledge of FDA and ISO Good Clinical Practice (GCP) Regulations, Medical Device Directive, Canadian Medical Device Regulation, and other international requirements
• Preferably certified as a Clinical Research Associate
• Minimum of 3 years monitoring experience with at least 1 year experience of monitoring Oncology studies in the U.S.A
• Excellent time management, project management, organizational, and communication skills (written and verbal) ) in local language and English
• Expertise in and excellent working knowledge of core systems and tools
• Preferred candidate will reside within the territory
• 5 years monitoring experience with at least 3 years experience of monitoring Oncology studies in the U.S.A
• Possess the ability to work independently and in a team environment
• Excellent time management, project management, organizational, and communication skills (written and verbal) in local language and English
• History of strong performance
• Skills and judgment required to be a good steward/decision maker for the company
• Possess an excellent working knowledge of all applicable ICH/GCP regulations
• Manage clinical monitoring activities, including
• Substantial monitoring experience in clinical research/Clinical Research Organizations
• Solid understanding of therapeutic indications and study protocol
• Ability to lead a "virtual" team
• Competent in written and oral English and local language
• Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL’s standard operating procedures
• Act as PAREXEL’s direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol
• Minimum 2 years of monitoring experience in clinical research
• Experience with CTMS preferred
• Establishment of a site recruitment plan in collaboration with site staff during QV
• Performing site documentation verification
• Data collection and drug accountability in accordance with ICH GCP guideline
• Monitoring patient safety on-site and addressing any violations in a timely manner
• Competent in written and oral English and Polish
• Assist with development / review of study documents, which may include clinical trial protocols, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals
• Assist with the review and analysis of clinical data for clinical trial report generation
• Assess adequacy of potential clinical investigators and clinical trial sites. Includes evaluation of facilities, personnel, patient referral base, and adherence to GCP/ ICH
• Act as one of the primary contacts between Seattle Genetics, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites. Maintain close contact with clinical trial sites
• Instruct clinical investigators and their personnel in regard to clinical trial protocol regulatory requirements, and with clinical trial specific training
• Travel alone or with CRO representative to clinical trial sites to monitor compliance with the clinical trial protocol, CFR, GCP/ICH regulations, and overall protocol objectives
• May act as Protocol Lead for small clinical trial, geographical region of large clinical trial, or close-out phase of any clinical trial study
• May perform routine clinical trial site monitoring functions
• BA/BS or equivalent or any relevant and qualifying training with a minimum of 4 years of relevant clinical trial management experience
• Requires strong communication, interpersonal, and organizational skills
• Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive is preferred
• Must be willing to travel ( < 10 – 20%)
• Serve as primary conduct for managing the relationship with assigned sites on behalf of UTC, cultivating productive relationships and understanding local challenges and opportunities
• Conduct site evaluation, initiation, monitoring and close out visits
• Develop and implement study specific monitoring tools
• Conduct clinical site initiation visits, advise and train site personnel on sponsor and regulatory requirements for study conduct
• Review on-site files and records, drug accountability, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provide remedial training and/or initiate corrective action as required
• Collect, review and process regulatory documents and correspondence from participating trial sites
• Provide site support for remote / electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits
• Perform termination of clinical studies through resolving final queries and completing closeout visits
• Regularly meet with PIs at assigned sites to keep them apprised of issues/concerns affecting the study
• Gain a working knowledge of the diagnostic / therapeutic field and clinical trial material (CTM) that is to be studied
• Provide support of CTM activities at site and study level. This may include study drug forecasting, assessing drug supply at clinical sites, reviewing and providing input on IVRS and drug accountability /reconciliation at clinical sites
• Develop and implement recruitment plans to enhance site enrollment
• Track personal finances for expense reporting and submission
• Must be able to submit trip and expense reports in a timely manner
• Conduct site evaluation, initiation, monitoring and close‐out visits
• Provide direction and training for other CRAs assigned to a project or study
• Drive project success by working closely with CTLs to develop and implement enrollment strategies, monitoring and tracking tools
• Provide quality accurate review of protocols and Informed Consent Forms (ICFs)
• Review on‐site files and records, drug accountability, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provide remedial training and/or initiate corrective action as required
• Track subject enrollment and participation at each trial site
• Maintain tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution. This may include maintaining site information on Clinical Trial Management System (CTMS)
• Meet with PIs at assigned sites to keep them apprised of issues/concerns affecting the study
• Respond to site’s questions about EDC use
• Collaborate with CTL and CRA manager to respond to audit findings at the site level
• Proficient in Microsoft Office (Word, Excel, PowerPoint)
• EDC and CTMS experience preferred
• Knowledge of regulatory and clinical practices (GCP, ICH)
• Must be able to demonstrate aptitude and knowledge in relevant therapeutic areas and/or ability to learn and integrate new/different therapeutic areas
• Must be detailed oriented, with strong time management and organization skills
• Demonstrated ability to successfully perform all aspects of site management
• Demonstrated understanding of relevant medical / therapeutic knowledge and medical terminology
• Excellent understanding of Standard Operating Procedures (SOP) and Good Clinical Practices (GCP)
• Strong interpersonal and written/oral communication skills
• Understanding of the clinical research process, regulations pertaining to good clinical practice, and the requirements to successfully take a candidate drug through registration
• Conduct Site Qualification, Initiation, Interim Monitoring, Close-Out visits and activities in accordance with FDA Code of Federal Regulations, Good Clinical Practice, guidelines, departmental procedures and the Clinical Monitoring Plan (CMP)
• Ensures records are complete and consistent with governing regulations
• Able to use or uses electronic data capture system and other monitoring tools to review and ensure accurate and complete clinical data collection
• Assists sites with site-level IRB submissions, queries and documentation
• Establishes and maintains regular communication with clinical sites
• Conducts on-site interim site monitoring activities including document review, source data verification, informed consent forms, other site documentation and study material accountability
• Prepare and complete monitoring visit reports and letters, and effectively document site communications Identify and address routine site issues including protocol deviations, subject recruitment and retention programs and communicate any observed study /data trends and proposed resolution
• Resolves non-routine site issues in conjunction with the Study Lead
• Assist with the development of clinical trial documents
• Ensures distribution, collection, and tracking of regulatory documents to ensure site compliance and audit readiness
• Assists in the validation and QC of clinical study database(s)
• Provides input into the development of Clinical Monitoring Plan, informed consent forms, template source documents, study manual, regulatory binder and other study-related documents as needed
• Advanced knowledge of clinical trial practices and regulations
• Advanced knowledge of clinical monitoring and trial design
• Proficient use of clinical trial databases
• Proficient knowledge of technical computer systems
• Willing to travel up to 50%
• College Degree and minimum of 2-5 years of clinical monitoring experience
• Project lead between the Mylan project team (PKDM Department, Product Development Department Chemistry Department, Quality Assurance Department, Mylan affiliate companies and various BD partners), clinical investigators and contract vendors for standard and complex bioequivalence studies
• Site Manager for 3-4 Bioequivalence (BE) established and new CROs with responsibility to oversee all projects assigned to that CRO. Train new CROs and ensure established CROs are compliant with all study protocols, overall clinical objectives, FDA, ICH and other regional guidance and regulations, internal SOPs and Mylan departmental policies and SOPs. Maintain all required regulatory study documents, monitoring records and correspondence confidentially and in accordance with Mylan document control procedures for each project
• Review all clinical and drug product documents for accuracy, completeness and timeliness internally and at the research sites. This includes review of Regulatory Documents, Drug Release/Accountability paperwork, Source Document templates, Case Report Form templates, Informed Consent Forms, Adverse Events, Dosing Logs, Protocol Deviations and Clinical Reports
• Conduct clinical monitoring of studies remotely and on-site as required according to Mylan Standard Operating Procedures (SOPs). This includes visit preparation, monitoring process, completion of the monitoring report, visit follow-up activities and travel to and from the clinical locations
• Interview clinical site research personnel in follow-up of monitoring visits and data issues. Communicate any substantial findings to his/her Supervisor during or immediately following a monitoring visit. Monitor and/or follow-up on the implementation of corrective action plans following clinical site inspections or audits, as required
• Assist in management of patient trials and clinical endpoint CRO services related to site management and monitoring functions to include co-monitoring as needed
• Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience in the field or related experience. However, a combination of experience and/or education will be taken into consideration
• Certification (i.e., ACRP) as Clinical Research Associate preferred, but not required
• Must possess knowledge of project management skills and pharmaceutical industry. Knowledge of and understanding of Good Clinical Practice and other associated regulations, guidelines and industry standards for clinical trials is required. Knowledge of medical terminology is desired
• Must possess excellent oral and written communication skills. Good organization skills, attention to detail, ability to work as part of a team and the ability to manage multiple tasks is required. Must possess planning skills for a range of 6 months to 2 years in advance of study deadlines. Should be proficient in PC applications (Excel, Microsoft Word, etc.). Should have the ability to read and interpret documents. Ability to write routine reports and correspondence. The successful candidate must maintain a high level of professionalism and personal integrity
• Ability to perform computations such as percentages, ratios, and rates. Ability to understand simple statistical analyses
• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems
• Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group or department
• 30% travel is required to include extended international travel
• Proficiency in speaking, comprehending, reading and writing English is preferred
• Perform all required tasks to ensure study execution under the supervision of the Manager Clinical Field Operations and Clinical Project Managers (CPM)
• The Lead Clinical Research Associate (LCRA) coordinates and leads Clinical Research Associates (CRA) and sites in EMEAC assigned studies/registries for THV
• The LCRA ensures that CRA activities are conducted in accordance with the internal quality system and external guidelines and regulations
• LCRA ensures that the projects are conducted according to protocol and associated documents and that agreed study milestones and timelines will be achieved
• The LCRA is responsible for the management of day-to-day aspects of study sites and CRA activities for the assigned projects and provides updates to the study team. As key member of the project team, the LCRA supports the development of the Monitoring plan and pays special attention to the adherence of the monitoring plan
• A higher education degree in a scientific, health care, or other related discipline required
• Minimum of 5 years field monitoring experience
• Excellent knowledge of written and spoken English (and local language as applicable)
• Expertise in communication, managing multiple priorities and computer literacy, supervisory and organizational skills
• Desirable other European language
• Understands and can apply knowledge of clinical trial designs to trial execution
• 40%: Study Start Up
• Facilitate CDA & Contract Execution Process (Routing and tracking of study specific contracts)
• Manage study specific PO Creation
• Collaborate with Study Manager and CRO to ensure accurate study specific CTMS setup and data feeds
• Liaise with Transparency group to ensure Clintrials.gov is updated accordingly
• Participate in creation and distribution of sponsor specific study aides/materials and communications
• Key point person for R&D select background checks
• Collate documents required for the EC/IRB/HA submissions
• 20%: Study Maintenance
• Assist Clinical Study Manager in tracking study related activities which are not appropriate to be outsourced
• Agenda distribution & minute taking for internal study team meetings
• Support SUSAR distribution
• Maintain internal & external contacts lists in CTMS
• Facilitate contract execution & study related PO creation for any change orders
• 25%: Departmental Tasks
• Maintain knowledge and act as team super user for related systems (e.g. CTMS, R&D Select, PO creation, Sharepoint)
• Maintain up to date training record attending internal/external training as necessary
• Participate in inter-departmental workgroups to create or enhance processes
• Take on career developmental activities/tasks as necessary
• 15%: Study Close Out
• Assist study team with preparation for audits/inspections
• Assist study team in close out in CTMS
• Liaise with Transparency group to ensure Clintrials.gov and results are updated/distributed accordingly
• Minimum 0-2 year's experience in relevant field (eg. Clinical Site, CRO, Sponsor or Clincal trial Vendor)
• You should thrive in project teams and be focused on delivering exemplary levels of customer service
• You will perform and coordinate all aspects of the clinical monitoring process
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
• Clinical research experience in all phases of study life cycle, including start up, interim and close out
• Equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
• Valid Driver's Licence
• Valid Passport
• Demonstrated performance management abilities
• Extensive monitoring experience
• Excellent judgment and decision making skills
• Excellent interpersonal skills and problem solving ability
• Ability to motivate and integrate teams and teach/mentor team members
• Able to effectively prioritize workload
• Knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc
• A minimum of 18 months on site monitoring experience
• In depth knowledge of ICH-GCP, EU and FDA requirements
• Excellent English/Swedish language skills
• Fluency in English and in the country's native language
• Expert knowledge of FDA guidelines, GCPs and applicable Standard Operating Procedures
• Skills to mentor and train other monitors in a positive and effective manner
• Excellent team player with team building skills
• Effective presentation skills
• Considerable clinical research monitoring experience (comparable to 5 years) with a demonstrated high level of expertise in all aspects of clinical monitoring
• Expert clinical monitoring skills
• Fluency in French, both written and spoken
• Independently performs monitoring visits, including Pre-Study, Study Site Initiation, routine Monitoring and Study Site Closure visits in accordance to GMCA SOPs and monitoring plan/conventions
• Documents monitoring activities in monitoring reports and follow-up letters. Communicates serious issues to the study team in a timely manner
• Serves as point of contact for investigators and site staff and maintains regular contact with study sites to ensure ICH-GCP/Regulatory/Protocol compliance, assessment of subject accrual rates and respond to sponsor/internal team prior, during and following site visits. Works with site personnel and study team to identify resolve and prevent issues
• Oversees monitoring activities for a study to ensure the accurate reporting of high quality data and timely query resolution; ensure data is collected from sites within given timelines
• Presents at and participates in Investigator Meetings, other study trainings and meetings as required
• Ensures quality of data in the event that a site or CRA performance issue has been identified at a previously monitored site
• Proactively prevents and identifies issues including study processes, monitoring or site issues
• Develops clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
• Develops the study Monitoring Plan and ensures CRA compliance with visit frequency and all assigned tasks throughout the study. Escalates CRA noncompliance to Study managers promptly
• Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization
• Oversees site start-up activities, including site selection and regulatory document collection, review, approval and tracking
• Develops study specific CRA training materials. Trains CRA team and tracks and maintains documentation of training throughout the life of the project
• Generates and utilizes metrics tools to assure study is running per timelines and to alert CRAs to potential issues (e.g., DM Query Trends, Missing CRF pages, Outstanding Monitoring Reports, etc.)
• Works closely with CSM and other functional groups; collaborates with other departments as required and reports trial site status
• Works closely with study managers for resourcing issues and to escalate pertinent CRA performance issues when necessary and provides feedback for annual appraisal
• Assists sites in the preparation of IRB / IEC submissions
• Works with CSM to manage vendors (e.g. Central Laboratory, CRF printers, Drug Distribution companies, etc.)
• Works with CSM to assure investigator payments are appropriate and paid on a timely basis (if applicable). Works with CSM to oversee monitoring budget (control time spent onsite, reviewing monitoring reports to be billed on monthly basis)
• Must have a strong understanding of Medical Terminology, Physiology and Pathophysiology
• Must be highly organized and able to produce high quality work independently or as part of a team be able to multi-task and work in a high volume, deadline controlled environment
• Must have an understanding of financial needs and processes (including Clinical budget), revenue forecasting / Recognition and invoicing practice
• Must have excellent writing, verbal communication, interpersonal and diplomacy skills
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Act as a mentor for new clinical staff
• We are seeking enthusiastic and motivated individuals who want to stretch themselves in an environment that encourages learning
• Able to work independently, you will enjoy communicating with others as you will meet a variety of healthcare professionals at monitoring sites, and interact with teams at Quintiles
• Successful candidates will hold a Degree in a scientific or healthcare discipline and will have monitoring knowledge and strong expertise in a CRO or pharmaceutical environment
• Experience in oncology is a plus
• We also require the flexibility to travel up to 60% of the time
• Fluent English Required (Oral and Written) as well as Computing Knowledge
• Reviewing regulatory documents and preparing site visit reports
• Participating in the study development and start-up processes
• Reviewing and following study protocols
• Designing and/or reviewing CRFs
• Preparing informed consent forms and developing study documents
• Organizing and presenting at investigator meetings
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• In depth therapeutic and protocol knowledge as provided in company training
• Strong written and verbal communication skills in Norwegian including a good command of English language
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Bachelor's degree in a health care or other scientific discipline
• Over one year of on-site monitoring experience
• Carry out assigned functions applying knowledge and skill in an accurate, timely manner
• Perform specialized tasks as trained in an independent fashion, requiring minimal ongoing direction. Assist in the establishment of procedures and research methodologies
• Monitor and maintain necessary supplies, with approval by senior department staff
• Maintain records of activities and notebooks in a professional, accurate manner
• Writes summary reports and supports protocol development
• Travel to clinical sites for training, auditing, and closing clinical sites for Alere-sponsored clinical studies
• Provide recommendations and observations to senior scientific staff on results of projects/tasks
• Operate equipment and conduct tasks in a safe manner, adhering to established guidelines and applicable regulations
• Interact with study coordinators at clinical sites to ensure optimal study progression and resolve problems
• Accurately enter clinical data into a database and identify errors and discrepancies
• Learn and apply knowledge of statistical methods to analyze clinical data
• Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
• Carries out duties in compliance with established business policies
• Perform other duties & projects as assigned
• Conducting clinical monitoring visits, (ie, pre-study, initiation, interim and close-out) which includes all preparatory and follow-up aspects with a range of travel at 50-75% (approximately 10 days per month, e.g. for assigned site visits, investigator meetings, co-monitoring)
• Trip report review
• Attending weekly sponsor/project management teleconferences
• Involvement in initial review of study documents
• May present at Investigator's Meetings
• Monitoring site performance and compliance and providing management with necessary reports, updates, and recommendations
• Preparing clinical sites for regulatory agency audits
• Assisting sites and data management with data query resolution
• Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; May coordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well
• Travels to field sites to monitor studies and provides technical assistance, when necessary
• Receives general instructions; plans and prepares studies
• Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites
• Assumes responsibility for training and coordinating certification of study site personnel
• Ensures accurate and complete study management/data collection and transfer to data management
• Assists, prepares and manages study timelines
• Conducts reference material testing in-house
• Participates in Project Team Meetings
• Keeps informed of trends and developments in clinical research
• Knows and effectively uses the broad concepts of a particular field or specialization to resolve problems of limited scope and complexity
• Analyzes alternative approaches to solve problems or develop new perspectives and existing solutions
• Manage / Contribute to the study site selection process by preparing feasibility questionnaires and conducting site interviews
• Organize investigator’s start-up meeting and study site initiation meetings
• Develop various study specific forms/templates and prepares/ manages study status reports
• Assist in vendor set-up, and oversight of vendors (including clinical CROs)
• Review essential documents from study sites for accuracy and completion. Request set-up of TMF and review for reconciliation of required documentation
• Be the first point of contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials
• Conduct monitoring visits and co-monitoring visits: coordinate with clinical investigators in the timely completion, submission, and review of CRFs and verify report data against protocol and patient files
• Provide support to clinical investigators and study coordinators to resolve site-related issues
• Communicate all relevant and critical issues to management
• Assure compliance for assigned projects with clinical research policies and procedures
• Manage progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Contribute to the review of all SAEs, ensure Medical Director sign-off, site notification and compliance with all company procedures
• Manage clinical aspects of database lock by participating in data listing review
• Provide guidance to product supply process and oversee site shipments in alignment with the Clinical supply group
• Contribute to clinical study design, proposals, and protocols
• Contribute to patient recruitment strategies to increase patient randomization into the trial (e.g. investigator and research nurse meetings, newsletter updates)
• Involvement in project follow-up (time planning, budget, project meetings) in collaboration with the CPM
• Contribute to the Global Project Team for the assigned projects (Core team member)
• Support junior CRA training
• Contribute to the improvement of departmental procedures ( eg GCP monitoring aspects etc)
• Comprehensive knowledge and understanding of Federal and International Guidelines as outlined in Title 21 of the Code of Federal Regulations, and ICH Guidelines of Good Clinical Practices required
• Has ability to understand the disease under study and the aim of the therapy. Should be able to understand the relevant sections of the study protocol. Monitoring experience preferred
• Has ability to maintain effectiveness under changing circumstances and priorities and must be able to handle multiple projects at a time and have strong attention to detail while keeping the global picture
• Must be able to expand knowledge and adapt to an increasingly complex environment
• Excellent verbal and written communication, presentation, interpersonal and organizational skills required and the ability to build effective relationships with site staff and colleagues
• Proactive approach, tact and diplomacy strongly required
• This position requires a sound knowledge of computer software and meticulous attention to detail
• Must have experience in Electronic Data Capture (EDC) system
• Should be process-oriented and should demonstrate a sense of urgency in completing deliverables through effective goal setting and a strong result orientation
• Strong organization, documentation, and interpersonal skills
• Ability to travel, including air travel, maintaining efficient and effective travel schedules, as the project could involve a lot of traveling, including overnight stays
• Bachelor’s degree / Master’s degree in scientific discipline or equivalent
• Minimum of 3-5 years clinical monitoring experience in a pharmaceutical, biotech, or medical device industry
• Excellent command of spoken and written English / French. Other languages are a bonus
• Assist in development of protocol, ICF, CRF, CRF completion guidelines, preparation and maintenance of monitoring plans, study binders, study manuals, and other site specific and monitoring tools
• Request and collect initial regulatory documentation
• Ensure that sites fulfill their regulatory obligations and submit study documents for IRB review and approval
• Perform study tracking and reports progress in a timely manner
• Plan and conduct training, site initiation, interim and close-out visits. Complete timely and accurate trip reports
• Track and account for study devices; assess and monitor that investigational devices are available, appropriately used, handled correctly, stored, and accurately inventoried and documented
• Monitor data and follow up with sites regarding timely completion and retrieval of CRFs and data correction forms
• Assist sites to resolve regulatory document issues; ensure adequate study and regulatory documentation is maintained at the both the investigator site and Bard
• Verify appropriate reporting and documentation of adverse device events, protocol deviations and subject enrollment
• Communicate findings from contact reports and monitoring visits to Senior Manager and/or Project Manager in a timely manner
• Initiate and track payments to study sites and external vendors as necessary
• Experience in monitoring clinical study data and managing site-related issues
• Knowledge of study protocols and case report forms, trial abstracts, and clinical publications
• Attention to detail and organizational skill
• Able to work with little supervision; must be a self-starter
• Possesses working knowledge of computer/PC skills with experience in Microsoft Word, Excel, Access, Microsoft Project and PowerPoint, network systems (electronic mail) and Clinical Trial Management Systems
• Minimum BS in scientific discipline or equivalent. At least 4 years related experience
• Preferred: BA/BS/Nursing education and/or equivalent clinical research experience, preferably 3-5 years of clinical experience, e.g. CRA in pharmaceutical, biotechnology or medical device company including CRO. In Europe, degree in Biology, Chemistry or other life science, if less than 3 years clinical operations experience
• Has familiarity with US Federal Food and Drug Administration, ICH/GCP/ISO, and European Regulatory Authority requirements, local regulations (e.g. JP) as applicable to a study
• Demonstrated proficiency in computer operations in Windows® environment and is able to utilize available software for documents, spreadsheets and electronic mall
• Must be able to handle multiple projects at a time and must focus on study specific needs while keeping the global picture
• Excellent verbal and written communication skills required. Able to produce accurate and well-presented documents. Interpersonal and organizational skills are a must. Solution oriented mindset
• Must be flexible in order to accommodate changes in team and project needs
• Must enjoy working in global/international teams and be inclusive to others
• This position is primarily sedentary work with the incumbent working in usual office working conditions with occasional walking/standing and lifting a maximum of 30 lb
• Ability to prioritize workload to meet study timelines while monitoring multiple protocols
• Work with the CRO and help provide documents to the clinical sites
• Assist in Site qualification telephone calls
• Assist in Development of Clinical Monitoring Plan and / or other study-related documents
• Review and process monthly site payments
• Initial review of AE’s and follow-up with CRO for necessary data for CEC meetings
• Ability to travel up to 30% domestically
• Basic knowledge of clinical trial methodology relating to the monitoring of clinical trials, GCP, FDA, and / or country specific regulatory environment
• Minimum of 5 years of field monitoring experience
• Medical device experience preferred
• Proficient in MS Office Suite of products
• Experience with Clinical Trial Management System preferred
• Experience with EDC system preferred
• Additional Desirable Qualifications Skills and Knowledge: Current Certification (CCRA) through ACRP
• Current Certification (CCRA or CCRP) through ACRP or SOCRA
• Independently responsible for all activities of the clinical trial including clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation
• Identify potential investigators, prepare site budgets and contract agreements
• Prepare study protocols investigator manuals, site specific instruction manuals and design case report forms for new and modified products
• Assist with the management of key study parameters (i.e. trial master files, start-up activities, preparation of precision study specimens, data collection and data analysis, etc.)
• Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem
• Stay up to date on major advances in infectious disease diagnosis, cancer detection and the use of new tests and advances in clinical practice
• The ideal candidate will have the following
• Bachelor’s degree or its international equivalent in Health, Behavioral, Life or Social Sciences or other fields related to international/ human development. Master’s degree preferred
• 3 - 6 years of previous clinical research experience with at least 3 years being clinical monitoring experience
• Articulate, professional and able to communicate in a clear, positive fashion with clients and staff
• Must be able to read, write and speak fluent English and Spanish
• Clinical Research responsibility for marketed products, product modifications, and/or assigned New Product Introduction (NPI)
• Coordination of safety plans and scheduling of biocompatibility testing with Corporate Toxicology
• Supporting the Product Development Lab by planning and conducting In House Clinical Studies (ICS)
• Preparation of clinical protocols, study documentation and clinical reports as well as ongoing clinical study documentation requirements
• Conduct study site feasibility and qualification assessments visits and monitoring visits throughout the conduct of assigned clinical studies
• Development and maintenance of product claims sheets to support sales and marketing
• Review and approval of marketing literature to ensure appropriate substantiation exists
• Bachelor's degree or higher in a science or engineering discipline from an accredited institution
• Minimum of one (1) year clinical research experience
• Experience in one or more of the following areas: clinical study coordination, medical device or pharmaceutical development, infection prevention, oral care (dental), wound care research and/or skin research
• Experience working in a hospital or clinical setting
• Knowledge of Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and Food and Drug Administration (FDA) guidelines
• Demonstrated experience in computer skills including Microsoft Word and Excel
• Good organizational, IT, and administrative skills as the job involves a lot of documentation and recording of information through computerized processes
• Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research, clinical trials and/or health or four (4) years related experience in lieu of degree
• A minimum of two (2) years of progressively responsible experience in biomedical research including a minimum of one (1) year directly related to overseeing multiple concurrent clinical trials and monitoring studies at clinical sites
• Clinical monitoring/site management experience
• Knowledge of clinical trial fieldwork, monitoring concepts and practices, FDA regulations and International Conference on Harmonization (ICH)/GCPs
• Knowledge of Clinical Trials Management Tracking Systems
• Familiarity with monitoring requirements to ensure integrity of data and site compliance as well as regulatory requirements and guidelines for clinical research
• Mental health experience
• Experience developing paper or electronic CRFs, manual of operations and study monitoring plans
• Association of Clinical Research Professional (ACRP), Certified CRA or SOCRA Certified Clinical Research Professional (CRP)
• 0-2 years of related experience in scientific research and analysis
• A minimum of 2 years specific training and/or experience completed or performed in Human Subjects Research preferred
• Knowledge of the Health Insurance Portability and Accountability Act (HIPAA) and the ability to manage Protected Health Information (PHI)
• Basic knowledge of Windows-based computer systems and applications to include Microsoft Word, Excel, and Outlook email
• Must read, write, speak, and understand the English language fluently and maintain good communication skills with patients and other health care personnel
• Possess experience with physiological data collection software
• Regulatory Documentation - Assures compliance with local regulations, Code of Federal Regulations (CFR)/ International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested. Responds to findings without oversight. May be responsible for submission of regulatory packages to ethics committees and/or competent authorities
• Monitoring - Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly reviews the status of the contents of the site regulatory binder; exhibits superior time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits
• Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Highly proficient with multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed
• Administrative - Prepares for and attends Investigator meetings. May attend Customer and Business Development meetings. May present materials, as requested. Assists with the preparation of study start-up materials and tools, as requested. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring and/or training plans
• Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF (or eCRF) completion, SAE re-porting, GCP, and possibly the drug mechanism
• Conduct feasibility and screen potential Investigators and networks to evaluate their capabilities for conducting clinical trials. Nominate sites to participate in studies in con-junction with Medical Science Liaison (MSL) and Clinical Research Medical Advisor (CRMA) colleagues
• Computer literacy and proficiency
• Ability to multi-task and prioritize multiple high-priority projects, site questions, CRA questions, and clinical team inquiries while managing responsibilities and deadlines
• Solid understanding of clinical development process including GCP and ICH guidelines
• Proven ability to work on teams and deliver on commitments
• Knowledge and experience in international (FDA, EMEA) and local regulations as well as Novartis stand-ards
• At least 2 years experience as CRA
• Bachelor's degree required (Advanced degree or certification preferred but not required)
• Minimum 5 years of experience in similar role (eg. Sponsor, CRO or Clinical Study Vendor)
• In depth knowledge of operational start up activities for phase I-IV clinical studies
• Ability to mentor peers to build on strengths/weaknesses and drive success
• Relevant experience in clinical research or related field
• General knowledge of regulatory requirements and guidelines governing clinical research
• Strong knowledge of MS Word, Excel, PowerPoint and Outlook
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines
• Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands
• Understanding how their input and role coordinate more effective business practices for Shire’s Clinical Development business and commitment to the culture, vision, and mission of Shire
• Ability to take ownership and manage tasks as well as communicate effectively
• Ability to lead others to drive deliverables forward
• Must be able to work in a fast paced environment
• Demonstrate ability to prioritize multiple competing tasks
• Ability to work with minimal supervision and complete tasks according to deadlines
• Available for up to 10% domestic and/or international travel
• Prepare study monitoring reports, per Standard Operation Procedures (SOPs) and applicable regulations
• Attend disease indication and project specific training and general CRA training as required. May participate in the training of other CRAs at meetings
• Perform additional roles and functions for GenMed Clinical Operations as assigned such as a Trial Lead CRA, systems superuser, or committee member
• Up to 2 years of prior experience in a clinical research role as either a CRA or site CRC or relevant experience
• Demonstrated ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to Management or Clinical Team
• Committee experience (CEC/DSMB/Steering)creating/leading independent physician committees
• Experience managing a core lab (Imaging, Echo or CT)
• Experience with putting processes into place (SOP, Charters, etc.)
• Experience creating study documents
• Enrollment experience
• Review on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance; identifies deficiencies and discrepancies and provides remedial training and/or corrective action as required
• Develop and implement study specific tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution
• Provide site support for remote/electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits
• Completion of monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies and recommended action to secure compliance
• Ensure that studies adhere to FDA regulations, Good Clinical Practices, and IVD directives
• Bachelor's degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent
• Prefer 1-2 years of experience with In Vitro Diagnostic (IVD) products
• Excellent communication and team skills
• Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc
• Experience in the handling and shipping of Bio hazardous specimens
• Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials
• Knowledge of GCP & ICH guidelines and FDA regulations
• Working knowledge of the diagnostic field and clinical trial material that is to be studied
• 30-50% travel required
• Good understanding of medical terminology, human physiology and laboratory testing
• Experience with laboratory automation and biological databases
• Previous hands-on experience in clinical research at either a diagnostic company/hospital or laboratory
• Knowledge of good clinical trial design, including the number and types of subjects and specimens that will be required, the conditions under which specimens must be collected, and the current gold standard for the diagnosis of disease
• 2+ years of previous pharmaceutical or medical device clinical study coordination, clinical site monitoring, or clinical study management experience required or equivalent combination of education and experience
• Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) preferred
• A background in biomedical/healthcare services with laboratory experience preferred
• Works within project teams to facilitate the conduct of standard study designs
• Participates in clinical affairs meetings and completes independent activities to support departmental functions
• Completes all internal training programs in a timely manner, and demonstrates professional development via independent reading, networking and training
• Adopts clinical practices that promote Quality First Time
• Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint)
• Well organized and detail oriented
• Impeccable record keeping and filing skills
• Ability to give presentations and teach others
• Ability to work effectively in a team, and also work independently on assigned tasks
• Ability to complete intermittent overnight travel up to 30%
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail
• Ability to remain flexible and adaptable in a wide range of scenarios
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
• Monitors investigator sites to ensure the accuracy and validity of CRF entries in
• Participates in investigator meetings as necessary. Identifies potential
• Maintains required functional and job specific training
• Moderate understanding of SOPs, WIs, FDA and local regulations as well as ICH-GCP guidelines
• On site experience: signed off to independently conduct at least two types of visits; PSSV, SIV, IMV, COV
• Experience of Observation/Training visit on all types of visits. Competent in independent drug accountability
• Competent in independent investigator site file review
• Demonstrates understanding of all Essential Documents and their collection and maintenance
• Off-site experience: familiarity with basic category of Clinical Monitoring Associate tasks. Ability to understand/guide site staff to execute on clinical protocols
• Understanding of local regulatory, safety, and GCP. Demonstrate proficiency in navigation within: CTMS systems, Data Platforms for projects, Microsoft Suite: Excel, Word, Power Point, Outlook, Site EMR systems
• Model professional communication in both written and verbal interactions
• Demonstrate sufficient time management to achieve required deliverables
• Ability to handle multiple tasks to meet deadlines in a dynamic environment
• Knowledge of clinical trial practices and regulations
• Knowledge of clinical monitoring and trial design
• College Degree and minimum of 1-2 years of clinical research experience. Monitoring experience is a plus
• Provides clinical study start up expertise and ensures identified efficiencies within study start-up are implemented
• Assists in providing oversight of site identification and selection
• Provides oversight of Clinical CRO activities regarding Legal review/negotiation/execution of confidentiality and site agreements
• Provides oversight of Clinical CRO activities regarding country and site specific informed consent documentation tracking, finalization and approval
• Ensures effective communication between Shire and the Clinical CRO
• Maintains knowledge and act as team super user or subject matter expert for related systems and processes
• Maintains up to date training record attending internal/external training(s) as necessary
• At least 3-5 year's experience in similar/relevant job (eg.Sponsor, CRO, or Clincal Study Vendor)
• Performing monitoring activities according to legislation requirements and Novo Nordisk SOPs
• Submission on Clinical Trials Protocol and Amendments to HA and EC
• Trial Site Initiation and Closure
• Preparing recruitment strategy at country and site level in agreement with Clinical Trials timelines
• Reporting of adverse events within the timelines given in local legislation/SOPs
• Site selection
• Contract preparation and negotiations
• Managing trial material and ensuring site are provided with the amount needed in timely manner
• Clinical Trial budgeting and monitoring of related expenses
• Support the investigator evaluation and recruitment process
• Perform essential document collection, quality control, review and tracking
• Ensure that Bard and investigator obligations are being met and are in compliance with the study protocol, GCP-ICH Guidelines and applicable regulations
• Support investigative sites in fulfilling their obligations with regard to submissions to local regulatory and IRB/IEC requirements
• Perform study file audits to ensure that the study files are current, accurate and complete
• Track clinical trial management metrics
• Provide support to internal and external teams to meet project specific goals
• Participate in project related meetings
• Assist with investigational product accountability, subjects screening/enrollment, case report form retrieval, query distribution to/retrieval from investigative sites
• Verify appropriate documentation and reporting of study events
• As required by certain projects, provide support to resolve internal and external clinical issues
• Assist in the creation and maintenance of clinical project documents, including project plans, monitoring guidelines, data management plans, site study manuals, monitoring visits reports, letter templates, study materials, template log forms and study presentations
• Interact with investigative sites, vendors and other Bard functional areas as secondary project contact for clinical issues
• Participate in site qualification and site initiation process, including scheduling of monitoring activities with site personnel
• May coordinate and conduct monitoring visits at participating research sites to ensure compliance to the investigational plan, regulations and timely receipt of data, including source document verification, device accountability and writing of monitoring visit reports
• Assist in training of Coordinators
• Responsible for data monitoring and study site management
• Work according to Good Clinical Practice, rules and regulations and internal procedures
• Support site identification, selection, i.e. recruitment & qualification, and initiation
• Assure study site management; conduct data and study site monitoring activities for clinical studies, assure investigators and study site personnel adhere to the study protocol, applicable local regulations, ICH/GCP guidelines and SOPs, monitor study progress, executes close out activities and authors related reports
• Oversee and coordinate the work of third party CRAs (CRO-CRAs)
• Support development of regulatory binders and investigational product shipments as applicable
• Other activities as assigned
• At least 2 years related experience in (conducting) clinical trials (healthcare setting , CRO, medical device and/or pharmaceutical company and/or industry)
• A demonstrated working knowledge of GCP, ICH guidelines, FDA/EU regulations
• Excellent record-keeping skills; good documentation practice
• Ability to maintain excellent working relationships with a broad range of trial staff
• Flexibility in work hours and readiness to travel
• Manages and oversees for the Bayer Consumer Health (BCH) Personal Care Franchise the operational conduct of all types of Consumer Research Studies (e.g. Sensory Testing, testing of Consumer Commodities or devices, Consumer Care Insight Tests / Consumer Tests) in humans in which a subject is physically exposed to a BCH product or active product ingredient from obtaining bids working with sourcing to final study report
• Works closely with Clinical Trial Manager on the preparation and conduct including monitoring of safety, efficacy and claims studies for Personal Care products. This includes amongst others the receipt of necessary documentation for the Trial Master Files (TMF) as well as TMF maintenance, control of budget, communication with and to Clinical Research Organizations (CROs), Laboratories, and other external vendors involved in the conduct of studies. Collection and maintenance of submission documents, including EC/IRB submissions
• Operational expert for the set-up, preparation and conduct of Sensory Testing, testing of Consumer Commodities, Consumer Care Insight Tests / Consumer Tests in humans in which a subject is physically exposed to a BCH product or active product ingredient
• Ensure that all applicable guidances including, however not limited to ICH Guidelines, GCP and SOPs are followed in all aspects of the studies
• Partner with CRO data management staff to process Case Report Form (CRF) and subject reported outcome questionnaire development
• Operational activities for the execution of efficacy, safety and claims studies for Personal Care Products
• Oversee administrative activities, maintenance of study documentation, collection and review of IRB/EC submissions
• Coordinating ethical committees/independent review board (EC/IRB)
• Perform study initiations, carry out interim monitoring visits with the timely completion of reports and oversee these activities conducted by internal and external CRAs and/or CROs
• Ensure timely recruitment of subjects and smooth running of subsequent operations, including data flow
• Account for and reconcile all used and unused trial supplies
• Closing down or oversee closing down of study sites on completion of the trial including archiving study documentation and correspondence
• Bachelor’s or (international equivalent) in Nursing, Life Sciences, Health Sciences or other scientific/health- related field. Minimum of four years of experience in clinical biomedical development, preferably with 2-3 years in the field of clinical trial monitoring as a CRA
• Ability to work on-site in Morristown, NJ
• Solid knowledge in in tracking clinical study costs against the budget
• Knowledge of, and adherence to ICH/GCP Guidelines, and as well as appropriate guidelines for clinical monitoring are required
• Knowledge and cross functional understanding of clinical trial methodology and logistics
• Team player with ability to work independently to accomplish objectives within timelines established by the Clinical Trial Manager and /or Project Teams
• Experience working in a matrix organization
• Position requires willingness for business trips, up to 25%, partially with significant frequency
• Excellent written and verbal communication skills, interpersonal and organizational skills are preferred
• Manage and oversee the Bayer Consumer Health (BCH) Personal Care Franchise the operational conduct of all types of Consumer Research Studies (e.g. Sensory Testing, testing of Consumer Commodities or devices, Consumer Care Insight Tests / Consumer Tests) in humans in which a subject is physically exposed to a BCH product or active product ingredient from obtaining bids working with sourcing to final study report
• Operational activities for the execution of efficacy, safety and claims studies for Personal Care Products, Oversee administrative activities, maintenance of study documentation, collection and review of IRB/EC submissions
• Ability to be On-Site in Morristown, NJ
• Experience in a pharmaceutical, biotech or CRO company
• Minimum 2-3 years of Clinical research experience, ideally with Vaccines and or/Infectious diseases and/or Oncology
• Management of regulatory and / or IEC questions
• Conduct site pre-study, initiation, routine monitoring, and study closeout visits
• Monitor, track, and manage all study related tasks at study sites ensuring compliance with GCP, ICH, applicable regulations and company SOPs
• Collect, review, track, and ensure appropriate completion of site-specific study/essential documents. Performs ongoing reconciliation of the Trial Master File (TMF) content to site files
• Primary contact for study site personnel
• Provide training to site personnel
• Track and report progress of study sites
• Responsible for quality data from study sites. Ensures appropriate source documentation, training, and accurate transcription of data into the study Case Report Form (CRF) as evidenced by minimal data query rates. Ensures timely reconciliation of data queries and implementation of process improvement/corrective action when needed
• May take meeting minutes, develop and maintain study trackers, or assume other tasks to support study team
• Coordinate, assemble, and ship study related supplies as needed
• Assist with creation and review of study tools/documents
• Maintains awareness of overall development in the field of clinical research based on current literature, attendance at professional meetings, continuing education, etc
• Requires a Bachelor’s degree (BA, BS or BSN) from a four-year college or university in a scientific discipline or equivalent combination of education and work experience plus minimum of two years pharmaceutical clinical research experience
• Knowledge of GCP/FDA/ICH regulations required
• Have a broad understanding of clinical research. Have a working knowledge of the relevant SOPs
• Have the necessary interpersonal and communication skills to establish professional working relationships with colleagues and site personnel
• Ability to work well under pressure and with tight schedules
• Ability to exercise judgment within generally defined practices and policies for obtaining data
• Self-direction and motivation are mandatory
• MS Word, Excel, in-depth knowledge of other presentation programs a plus
• Must be available to work in the evenings and weekends, as required
• Must have the quality-service attitude and be willing to work additional hours to meet deadlines
• Participates in the design and monitoring of clinical trials
• Analyzes and evaluates clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives
• Performs a variety of complicated tasks
• Typically reports to a supervisor or manager
• Knowledge of FDA regulatory requirements is required
• Familiar with a variety of the field's concepts, practices, and procedures in a clinical research setting
• Participates in the design, administration and monitoring of clinical trials
• Analyzes and evaluates clinical data gathered during research
• Ensures compliance with protocol and overall clinical objectives
• Relies on instructions and pre-established guidelines to perform the functions of the job
• Works under immediate supervision
• Primary job functions do not typically require exercising independent judgment
• Knowledge of commonly-used concepts, practices, and procedures within a clinical research setting
• Bachelor's degree, typically in nursing or scientific field, or the equivalent
• 4+ years direct CRA experience in the pharmaceutical industry or equivalent in clinical study management
• Ability to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
• Possess excellent organizational skills
• Ability to effectively communicate and interact with key contributors including but not limited to physicians and clinical staff and to communicate technical information both verbally and in writing
• Ability to manage multiple tasks simultaneously
• Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with 2 years' experience in clinical setting
• 2+ years of relevant clinical experience in a CRO or pharmaceutical industry
• Excellent communication, organization and tracking skills
• Strong operational skills and demonstrated ability to meet timelines
• Proven ability to work both independently and in a team setting, including a matrix environment
• Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process
• Evaluates and analyzes clinical data
• Must have knowledge in reference to good clinical practices regulations and standard operating procedures
• Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives
• Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings
• May draft materials including informed consent documents, draft source documents, patient instruction guides and case report forms
• Conducts clinical monitoring of field sites to supervise and coordinate clinical studies
• May write protocols
• May require travel to field sites
• Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA)
• No experience required with Bachelor’s degree
• Ability to lift and carry up to 25lbs
• Excellent verbal and written communication/customer service skills
• Designs, plans and implements the overall direction of clinical research projects
• May draft materials including informed consent documents, draft source documents, patient instruction guides and case report forms (CRFs)
• Assists with the recruitment of research participants and the collection, management, and analysis of specimens and data
• Assists with protocol development and contributes to the preparation of regulatory submissions to the Institutional Review Board (IRB)
• Monitors intramural research protocols and ensures the clinical trials are conducted in accordance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and all applicable regulatory guidelines
• Assists with opening, monitoring, and closing studies, clinical site management, and managing the relationship with Clinical Research Organizations (CROs) and field CRAs
• Ensures appropriate reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Reviews clinical trial data for quality and completeness
• Tracks patient enrollment, randomization, and drug dispensing
• Ensures the safety and confidentiality of study subjects
• Interacts with internal and external staff to facilitate project timelines
• Assists in preparing documents to be submitted to the Food and Drug Administration (FDA), as well as annual protocol reports, manuscripts, and abstracts for publication
• Attends laboratory and clinic meetings, clinic conferences, and other seminars/meetings
• Travels occasionally for domestic and international conferences
• Acts as the liaison to NIH and CNMC staff to ensure clinical trials are well coordinated
• Coordinates and guides patients through study visits and is the Point of Contact (POC) for patients associated with the different studies
• Works in collaboration with the Study Coordinators and Case Managers associated with the studies
• Possession of a Bachelor’s degree from an accredited college or university according to the Council Higher Education Accreditation (CHEA) in a field related to biomedical research, clinical trials and/or health, or four (4) years related experience in lieu of degree
• Must be able to obtain and maintain a Public Trust Clearance
• Biomedical research or clinical related experience may be substituted for the degree
• Ability to work in a clinical research setting both independently and within a team environment
• Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
• Ability to communicate effectively, orally and in writing, with non-technical and technical staff
• Familiarity with FDA regulatory requirements and guidelines for clinical research, as well as monitoring requirements
• Infectious disease experience
• Knowledge of Department of Health and Human Services regulations
• Experience with the development of CRFs, FrameMaker® and TrackWise®
• Will assist the Clinical Project Manager and/or Clinical Affairs representative as a team leader on assigned project teams to provide clinical guidance, strategy, and support for the development of new technologies, new products, and extended product claims
• Assist in the design and develop key clinical study documents (e.g. informed consent forms, monitoring plans) ensuring that the study will produce sound and thorough data to support the approval process; seek input as needed from cross-functional team members
• Oversee and adhere to study protocol, budget and timeline
• Ensure maintenance of clinical project files to ensure compliance with internal procedures, and applicable country-specific regulations
• Serve as a clinical expert to study site staff, investigators, sales representatives, and other staff members regarding investigational products and protocol
• Involved in the preparation of documents for publications, submissions and the coordination of submissions
• Effectively identify, build, and leverage effective relationships with external advisors, clinical investigators, vendors, and applicable research staff
• Provide project updates to effectively communicate to management on a regular basis
• Participate in work streams and or process improvement initiatives
• Develop training materials and serve as mentor to CRA staff
• Strong understanding of cardiovascular anatomy, pathology and physiology
• Able to coordinate and lead multiple projects simultaneously in a fast-paced work environment
• Assess adequacy of potential clinical investigators and clinical trial sites.Includes evaluation of facilities, personnel, patient referral base, and adherence to GCP/ ICH
• Act as one of the primary contacts between Seattle Genetics, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites.Maintain close contact with clinical trial sites
• Must be willing to travel (< 10 – 20%)
• Experience in Immunology monitoring is preferred
• Proven strong site management and monitoring skills
• Good negotiating skills, tact and diplomacy
• Job Description
• REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
•  Strong knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
•  Strong therapeutic and protocol knowledge as provided in company training
•  Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
•  Strong written and verbal communication skills including good command of English language
•  Strong organizational and problem-solving skills
•  Effective time management skills
•  Ability to manage competing priorities
•  Good mentoring and training skills
•  Ability to establish and maintain effective working relationships with coworkers, managers and clients
• MINIMUM REQUIRED EDUCATION AND EXPERIENCE
•  Bachelor's degree in a health care or other scientific discipline or educational equivalent and 2 years of on-site monitoring experience; or equivalent combination of education, training and experience”
• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
• Act as a mentor for clinical staff including conducting co-monitoring and training visits
• May provide assistance with design of study tools, documents and processes
• Strong knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Strong therapeutic and protocol knowledge as provided in company training
• Strong organizational and problem-solving skills
• Good mentoring and training skills
• Bachelor's degree in a health care or other scientific discipline or educational equivalent and 2 years of on-site monitoring experience; or equivalent combination of education, training and experience”
• Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study
• Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries
• Perform SAE review and reconciliation
• May review protocols, eCRFs, study manuals and other related documents, as requested by Clinical Trial Manager and/or Lead CRA
• Serves as primary contact between Novella and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested
• Authorized to request site audits due to data integrity concerns
• Ensure internal and study-related training's are completed per Novella and/or study timelines; CTMS should be current at all times with the pertinent site updates/contacts
• Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study
• Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions
• Review and approve CRA travel expenses and time sheets
• Must possess 2+ years of oncology and/or medical device experience
• Working as part of an international clinical team which is led by the Clinical Trial Manager
• To ensure appropriate attention is provided to the sites in order to drive data quality so that the clinical study protocol requirements are fulfilled within the appropriate regulatory and ethical framework
• Knowledge of local regulatory, ethics and institutional contract procedures and submissions
• Demonstrated experience of performing site start up procedures, routine monitoring and site closure
• Excellent interpersonal and organisational skills
• Ability to manage multiple priorities across various clinical trials
• Fluency in both French and English (spoken and written) is essential
• Valid drivers’ licence and ability to travel throughout France and Belgium
• Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research
• BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years of monitoring experience or equivalent amount of education/experience
• Must possess excellent verbal and written communication, interpersonal and organizational skills
• Requires an ability to work independently, prioritize, and work within a matrix team environment
• Collaborates with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
• Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities
• Collaborate with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
• Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities
• Assist the study management in identifying and generating changes in scope
• Serve as mentor for junior CRAs and those new to the company and/or study
• Excellent, presentation, organizational and interpersonal skills
• For the Technical CTM role, the CRA must have a deep understanding of Novella systems with the ability to learn even more
• In the country/region based, manages activities of clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol
• Conducts all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives
• Identifies and communicates issues that impact resource allocation and provides solutions
• Anticipates and identifies site issues that could affect timelines and develops alternative solutions
• Provides input to forecast resource requirements for assigned clinical studies in the country(ies) responsible for
• Works in partnership with study teams to resolve critical and complex issues with study conduct at clinical sites
• Under direction of the Clinical Operations Manager and/or Senior Clinical Operations Manager, provides strategic direction, advice and guidance to assigned local Site Management & Monitoring staff in relation to clinical operations responsibilities and activities; promotes best practice; enables provision of quality local services to AbbVie; identifies infrastructural improvements and implements action plan to ensure Site Management & Monitoring and business objectives are successfully met; ensures alignment of local Site Management & Monitoring activates with regional/global initiatives
• Ensures project implementation within country(ies)/region(s)/responsible for
• Provides hands-on assistance to assigned staff for project implementation as needed
• May participate in global Task Forces and Initiatives
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs_ and to quality standards in conducting clinical research are maintained
• Ensures that compliance requirements to competent authorities and HQ are met
• Participates in the development of local SOPs or working instructions as needed, interacting with appropriate local functions
• Work with appropriate staff to ensure that clinical trial management systems containing all study-specific information are maintained and kept current
• Track and manage performance metrics for assigned monitoring staff
• Ensures financial information for assigned studies/sites is entered into company systems in a timely manner and is managed in compliance with company policies (ex-US)
• Candidate should be located in Maryland
• Ensures regulatory inspection readiness at assigned clinical sites
• Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to
• Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives. Is proactive in managing the site and ensures action plans are put into place as needed to ensure compliance
• Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations
• Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner
• Employs good financial management to conserve costs of departmental operation and control travel expenses, with guidance from Senior ACOM/COM/Sr COM as appropriate
• Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders
• Maintain and complete own expense reports as per local and applicable guidelines
• Identifies, evaluates and recommends new/potential investigators/sites on an on­ going basis
• Creates a positive work environment by encouraging mutual respect, innovation, and accountability at all levels
• Candidate should be located in New York
• Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred
• Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring
• Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
• Experience in on-site monitoring of investigational drug or device trials is required
• Competence in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications
• Research experience in investigational drug trials preferred
• Skilled in organization and implementing requirements of research protocols
• Knowledge of the design, conduct and critical review of clinical trials with the appropriate skills required performing the functions of the positions
• Phlebotomy license/skills required
• Maintains required and functional job specific training
• Performs other work-related duties as assigned
• Acts a representative of the Company, demonstrates professional attire, attitude and behavior in meetings & teleconferences, site visits and interactions, and interpersonal activities in general
• BA/BS degree in science/health care field or nursing degree or equivalent combined education and experienceBA/BS degree in science/health care field or nursing degree or equivalent combined education and experience
• Extensive experience as a CRA with a thorough understanding of SOPs, WIs, FDA and local regulations as well as ICH-GCP guidelines
• On site experience: signed off on all types of visits; PSSV, SIV, IMV, COV. Experience of Observation/Training visit on all types of visits
• Experienced at independent drug accountability and evidence of proactive identification / escalation / resolution of any issues found
• Experienced at independent investigator site file review and evidence of proactive identification / escalation / resolution of any issues found
• Off-site experience: mastery of basic category and familiarity with complex category of Clinical Monitoring Associate tasks
• Comfortable in navigation within, and able to assist junior staff in: CTMS systems, Data Platforms for assigned projects, Microsoft Suite: Excel, Word, Power Point, Outlook, Site EMR systems
• Model consistent professional maturity as represented by: Approaching mastery of professional communication in interpersonal and written work
• Demonstrating conflict management skills such that the CRA is able to navigate challenging site relationships successfully
• Ability to cultivate strong relationships and establish credibility to influence others in situations without direct authority
• Has good knowledge of Strategic Data Monitoring
• The main purpose of this role will be to perform all required activities to ensure appropriate monitoring of investigator sites and study execution under the supervision the Manager Clinical Field Operation
• The Senior Clinical Research Associate (SCRA) implements and coordinates assigned clinical research projects in EMEAC
• The SCRA ensures that activities are conducted in accordance with the internal quality system and external guidelines and regulations. SCRA ensures that the projects are conducted according to protocol and associated documents and that agreed study milestones and timelines will be achieved. The SCRA needs to adhere to Monitoring Plan
• High education degree in a scientific, health care, or other related discipline required
• Minimum of 2 years of monitoring experience in the cardiovascular field
• Submission experience to the regulatory bodies and Ethical committees in Spain
• Excellent knowledge of written and spoken English, Spanish and French
• Flexibility to travel (up to 70% of the time)
• Perform all required activities to ensure appropriate monitoring of investigator sites and study execution under the supervision the Manager Clinical Field Operation
• The SCRA is responsible for the management of day-to-day aspects of study sites for the assigned projects and provides updates to the study team
• Minimum of 4 – 5 years field monitoring experience
• Conducts Site Qualification, Initiation, Interim Monitoring, Close-Out visits and activities in accordance with FDA Code of Federal Regulations, Good Clinical Practice, guidelines, departmental procedures and the Clinical Monitoring Plan (CMP)
• Prepares and completes monitoring visit reports and letters, and effectively document site communications Identify and address routine site issues including protocol deviations, subject recruitment and retention programs and communicate any observed study /data trends and proposed resolution
• Assists with the development of clinical trial documents
• Provides leadership, training, and mentoring, as needed
• Works on multiple projects and may function as a Study Lead
• College Degree and minimum of 5-8 years of clinical monitoring experience
• Coordinate the tracking of Essential Documents and key operational metrics for assigned studies
• Perform Quality Control (QC) reviews of study documents to ensure that they are complete, accurate, and verifiable, and ensure that documents do not contain any PHI (Protected Health Information) in compliance with HIPAA requirements
• Load and maintain study documents in Bard’s eTMF (electronic Trial Master File)
• Interact with Investigational Sites to obtain study documents and related information
• Update and maintain Bard’s Clinical Trial Management System (CTMS) for assigned studies to ensure accurate tracking of study contacts, vendor contacts and expiring study documents
• Coordinate and participate in periodic review/audit of Trial Master Files to ensure that essential study documents remain complete, accurate, and verifiable
• Assist in the development of study materials and tools to assist investigative sites during the clinical trial. Examples include regulatory and source document binders, template forms for Screen/Enrollment logs, Delegation logs, Device Accountability logs and training materials
• Update and maintain project related systems, databases, tracking tools, timelines, and project plans (e.g., clinicaltrials.gov; SharePoint, etc.)
• Under the direction of the study manager, coordinate investigational device inventory and accountability. This may include ordering devices from vendors for shipment to investigative sites, ensuring receipt at the site and tracking and accounting for all study devices at the end of the study
• Coordinate the reporting and follow-up of reportable adverse events to Bard’s field assurance team
• Prepare and distribute letters, memos, meeting minutes, and clinical administrative documents
• Coordinate the receipt and processing of invoices, purchase orders, and purchasing requisitions, and track site/vendor payments
• Coordinate project team meetings as needed (e.g., schedule rooms, coordinate logistics, prepare agendas, prepare/distribute minutes, etc.)
• Strong organizational skills and a keen attention to detail
• The ability to interpret and analyze a broad range of technical documentation
• The ability to work independently at times with minimal supervision
• Strong oral and written communication skills with an ability to proofread technical documentation for correct grammar, syntax, and spelling
• Proven ability to prioritize multiple tasks in a fast-paced business environment
• Proven ability to plan work and complete assignments on time
• The ability to maintain confidentiality about information received in the course of duties
• Strong computer skills with experience in Microsoft Outlook, Word, Excel, Access, Project and PowerPoint, and the ability to quickly learn and navigate Bard’s internal network systems (e.g., CTMS, SharePoint, etc.)
• Knowledge of GCP-ICH and International regulatory requirements governing medical device research and development
• Prior experience coordinating industry sponsored clinical studies
• 85% - Clinical Trial Support (May include but not limited to activities listed)
• Assist in providing oversight of CRO activities regarding country and site specific informed consent documentation tracking, finalization and approval
• 10% Departmental Tasks
• 1-3 year's experience in similar/relevant field (eg.Sponsor, CRO, Clincal trial Vendor, Clincal Coordinator, etc.)
• Assume ambassadorial role to facilitate communication between sites and Novartis line functions and increase value proposition to investigators
• Facilitate preparation and collection of site level documents; resolve problems as required
• Execute site initiation and training
• Implement total site management including monitoring visits, regulatory assessment, drug supply management and resolution of site problems to ensure compliance
• Track trial execution milestones; identify problems; resolve issues and escalate as appropriate
• Manage recruitment and execute contingency plans, as needed. 8. Complete preparation/generation of study monitoring reports
• Manage data at the site; resolve technical and content issues to achieve aggressive database lock targets
• Implement site closeout activities
• Act as local and/or global CRA lead and author global monitoring plan
• Act as a mentor to new associates for purposes of field training, as assigned
• Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvements
• Foster sound working relationships with both internal and external customers
• Participate in initial and on-going protocol and CRF training
• May serve as the primary contact for the clinical sites/sponsor
• Participate in the generation of study specific monitoring plans
• May assist in the development of protocols and Case Report Forms
• Participate in sponsor and investigator/initiation meetings
• Tracks progress of assigned studies projects and identifies appropriate actions to achieve target objectives
• Fulfill on-site monitoring responsibilities
• Ensure that study staff conducting the protocol have received the proper materials, instructions and training to safely enter subjects into the study and complete the protocol requirements, as written
• Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of the data submitted on CRFs or other data collection tools by careful source document review
• Ensure that the site regulatory documents are complete and current throughout the duration of the trial
• Ensure that the study investigational product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements
• Identifies and completes follow up of SAEs at study site for which he/she is responsible
• Typically 2 years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, or data management)
• Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
• Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
• Fluent in local office language and in English, both written and verbal
• Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Excellent registry administration skills
• Good planning and organization skills
• Good computer skills with good working knowledge of a range of computer packages
• Responsible for study startup which include IRB/IEC submission, site selection, recruitment of potential investigators, notifications to regulatory authorities, translation of study-related documentation
• Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
• Responsible for all aspects of site management as prescribed in the project plans
• Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
• May support in organization of meetings and other tasks as instructed by supervisor
• Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) with 1 year of phase I monitoring experience is preferred
• Good communication, interpersonal, analytical and negotiation skills
• In lieu of the above requirements, candidates with > four (4) years supervisory experience in a health care setting and three (3) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may be considered
• Excellent site monitoring skills
• Excellent study site management skills
• Ability to train and supervise junior staff
• Ability to resolve project-related problems and prioritizes workload for self and team
• Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor
• Interact with internal work groups to evaluate needs, resources and timelines
• Assist with training, mentoring, and development of junior employees, e.g. co-monitoring
• Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned
• Minimum 4 years of relevant clinical research experience in pharmaceutical or CRO industries
• Experience in different therapeutic areas with the emphasis on oncology (3 years)
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
• Minimum of Four (4) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
• Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Assisting with training, mentoring, and development of new employees, e.g. co-monitoring
• Previous clinical research experience in pharmaceutical or CRO industries
• Fluency in Hungarian
• Very good knowledge English language
• Minimum 2 years of monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) - oncology experience highly preferred
• Oncology experience is a definite plus
• Fluent in English and local language, both written and verbal
• Monitoring skill, site management skill, communication skills
• Good planning and organization skill, computer skills
• Ability to resolve project related problems and priorities workload and work in a team
• Meets all requirements of the Clinical Research Associate (I) level
• Assists with the implementation of Project Plans related to the Clinical Monitoring responsibilities
• Participates in initial and on-going protocol and CRF training at study site
• May serve as the Primary contact for the clinical sites/Sponsor
• Participates in the generation of study specific monitoring plans
• May participate in the development of Case Report Forms
• Participates in the development of and/or review of conventions for CRF transcription
• May develop materials for site reference manual
• May participate in identification and recruitment of investigators, collection of investigator documents and Pre-Study Visits
• Participates in Sponsor and Investigator/Initiation Meetings
• Tracks progress of assigned studies/projects and identifies appropriate actions to achieve target objectives
• Fulfills general on-site Monitoring Responsibilities
• Typically 2 - 4 years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, or data management)
• Typically 1 - 2 years Clinical Monitoring experience
• Additional experience may be substituted for monitoring experience – specifically, experience in the role of Research Nurse or Clinical Research Coordinator can be substituted for experience in Clinical Monitoring, provided the incumbent participants in a comprehensive program of monitoring skills training provided by Covance at the outset of employment, and demonstrates proficiency in monitoring skills via assessment prior to independent conduct of clinical monitoring activities
• Proficient computer skills with good working knowledge of a range of standard computer software required (e.g. email, document, spreadsheet and presentation software)
• All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits
• Degree educated (Life Science)
• Few years of relevant clinical research experience in pharmaceutical or CRO industries
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
• Full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Fluent Norwegian and English language skills
• Ideally minimum of 2 years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) at a CRO or Pharmaceutical environment
• Fluency in German and English. Able to monitor in either French or Italian
• Strong background in IT applications and E-CRF experience
• Training skills to train sites to perform excellent
• A valid driving license
• Available for travel up to 60% of the time, including overnight stays as necessary
• The clinical research associate will be responsible for ensuring that the sites used for clinical studies meet ICH GCP requirements
• CRAs will visit clinical trial sites for pre-qualification, site initiation, interim monitoring and site closeout
• The CRAs are also responsible for documenting study visits, and participate in study planning and coordination
• Bachelor's Degree required, certification as a CRA or clinical research professional highly desired
• Experience monitoring sites for human clinical trials, site initiation, monitoring, and closeouts desired
• Attention to detail is critical as well as excellent oral and written communication.Search Jobs US
• Undertake feasibility work when requested
• Minimum 2 years of relevant clinical research experience in pharmaceutical or CRO industries
• Knowledge of Hungarian, Romanian and English languages is a must
• Contract negotiation experience
• Understanding of the clinical trial process
• Ensures adequate documentation and proper implementation of written protocols
• Serves as a liaison between Align Technology and the study site, investigators, study coordinators, staff members
• Provides technical assistance to study sites regarding the conduct of clinical research
• Oversees delivery and shipment of aligners for clinical studies
• Follows all departmental and company procedures as indicated in quality, administrative, or other systems
• Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources
• Travel may be required – up to 15%
• 1-2 year experience as a Clinical Research Associate
• Ability to think critically and scientifically
• Ability to write clinical reports and protocols
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors, responsible for all aspects of site management and registry management as prescribed in the project plans
• Organize and make presentations at Investigator Meetings
• Preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
• May assist with, and attend, Investigator Meetings for assigned studies
• May serve as mentor for new clinical study monitors
• Attend study-related, company, departmental, and external meetings, as required
• Conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs
• Working knowledge of all functional areas of clinical trials and medical terminology
• Take charge of all aspects of Site Management as prescribed in the project plans
• Negotiate study budgets with potential investigators and collaborate with the Covance legal department with statements of agreements as assigned
• Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines
• Senior CRA positions require 4+ years of clinical research monitoring experience. Alternatively candidates with 4+ years supervisory experience in a health care setting and 3+ years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may also be considered
• Minimum of three (3) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
• In lieu of the above requirements, candidates with > three (3) years supervisory experience in a health care setting and two (2) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may be considered
• Ability to resolve project-related problems and prioritizes workload for self
• Conducts trip report review for assigned projects
• Tracks visit and trip report metrics and summarizes/reports to teams; creates and implements tracking tools, as needed
• Manages monitoring needs of the study and initiates proposed solutions to CRA managers if additional CRA resources are needed
• Reviews site data quality trends via trip reports and data review including queries and protocol deviations
• Reviews site feasibility questionnaires in preparation for Pre-Study Visits (PSVs) and site selection
• Participates in CRA project-specific training
• Supports face-to-face sponsor meeting preparation and may develop materials related to the training and presentations for Investigator Meetings; may present at meetings
• Facilitates CRA project meetings (agenda and minutes) and is the primary responsible for communicating study information to the CRAs; may work with the Project Manager/Clincial Trial Manager to facilitate these meetings
• Provides a key role in problem solving and issue escalation, regarding monitoring issues, with proposed solutions to Project Management team and Sponsor as needed
• Mentors and co-monitors with CRAs on assigned team as needed
• May observe the first SIV and conduct observation visits and co-monitoring visits to address site and CRA performance needs
• Conducts all types of clinical monitoring visits (i.e., pre-study, initiation, interim and close-out) which includes all preparatory and follow-up aspects
• Attends weekly sponsor/project management teleconferences
• Involved in initial review of study documents, eg, protocol, CRFs, source documents, drug accountability, and informed consent
• Assists sites and data management with data query resolution
• Travels as required by study and site/CRA performance
• Miscellaneous duties, as necessary, in support of Clinical Monitoring initiatives and business priorities and objectives
• Excellent written and verbal communication skills in order to effectively communicate to a wide variety of audiences including senior management
• Ability to anticipate study monitoring needs and provide solutions to the CRA Manager and project team
• Ability to travel as needed (10-20%)
• W2 Employees Only - Must have Device experience**
• At least 5 years related experience in (conducting) clinical trials (healthcare setting , CRO, medical device and/or pharmaceutical company and/or industry)
• Experience in electronic data capture and clinical trial management systems
• Conducts all types of clinical monitoring visits (i.e., pre-study, initiation, interim and close-out) which include all preparatory and follow-up aspects, with oversight, as needed)
• Attends weekly project CRA teleconferences, as appropriate
• Monitors site performance and compliance and provides LCRA with necessary reports, updates and recommendations
• Prepares clinical sites for regulatory agency audits
• Travels as required by study
• Develops subject recruitment strategies and works with sites on meeting enrollment timelines
• Performs miscellaneous duties, as necessary, in support of Clinical Monitoring initiatives and business priorities and objectives
• Detailed knowledge of FDA regulations and GCP/ICH guidelines as they apply to the conduct of clinical research
• Ability to travel on a regular basis
• Working knowledge of Microsoft Office Suite
• Able to complete complicated tasks high independently, able to perform and lead study specific
• Bachelors degree in clinical medicine or a life/biological science
• Good computer skills including proficiency with Microsoft Word, Explorer and Outlook and
• Assist with management of third party vendors
• Monitor and manage study sites, as necessary
• Track and prepare study- specific information utilizing databases, spreadsheet and other tools
• Assist in the development, assembly and distribution of study documents, manuals and tools
• Reporting of study issues to Sr. Manager or Clinical Operations Director/Sr. Director
• Maintains and manages internal clinical trial files and documents
• Coordinates and plans for the availability of non-clinical supplies necessary to meet study requirements
• Travel to sites when necessary (~50%)
• The candidate must have a BA/BS degree or equivalent; health science degree or biologic science degree is preferred. A minimum of 5 years experience in the pharmaceutical industry, with minimum 3 years direct experience in monitoring and managing study sites
• The candidate should have significant experience with responsible roles in the conduct or management of Phase I – III clinical trials
• The candidate should be detail-oriented, a self- starter and be comfortable with broad responsibilities in an
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visit; liaise with vendors; and other duties, as assigned
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of data submitted on Case report Form (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data
• Manage small projects under direction of a Project Manager/Director as assigned
• Serve as lead monitor for a protocol or project and may assist in establishing monitoring plan as assigned
• External Candidated
• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure),
• Management of Australasian clinical investigator sites from site identification through start-up, recruitment & maintenance and close-out as part of local or global clinical studies according to ICH GCP guidelines and GSK SOPs
• Clinical Trial Document management
• Involvement in negotiating financial arrangements with sites within agreed limits, document financial agreements accordingly and co-ordinate timely payments to sites
• Setup, co-ordinate and contribute to investigator meetings when necessary
• Maintain good communication and working relationships with investigators, other site staff, overseas colleagues, external customers and other GSK staff
• Uphold and promote the company externally by demonstrating high professional standards and integrity in all external contacts
• Involvement in the regular review of procedures and practices involved in planning, set-up, monitoring and co-ordinating clinical trials
• Be familiar with relevant therapeutic areas and clinical research procedures by attending both core and on-going training sessions, reading/viewing relevant materials and by discussion with internal and external experts
• Tertiary qualification in health, social and/or biological science, pharmacy
• Some prior Clinical Research Associate experience
• Well developed verbal and written communication skills
• Excellent interpersonal skills; including the ability to competently liaise with and feedback to internal and external customers regarding project issues and company decisions
• Attention to detail and ability to work to achieve required timelines
• Commitment to continuous learning and improvement
• Ability to negotiate with and motivate others
• Conducting on-site Accompanied Field Visit activities (Quality Control Visits) for CoSource staff
• Effectively communicating management strategies, policies and procedures in conjunction with leadership teams
• Developing and maintaining effective relationships with client management teams to manage CoSource staff in a matrix environment
• Maintaining good working relationships with internal and external clients to ensure opportunity for supporting additional new business
• Forecasts country resource needs
• Oversees country and site validations, site selection and recruitment in assigned protocols responsible for clinical trial education to sites
• University/college degree (life science preferred), or certification in a related allied health profession
• In lieu of the above requirement, candidates with several years of relevant clinical research experience in pharmaceutical or CRO industries will be considered
• Fluent in local office language and in English
• Relevant clinical research experience in a pharmaceutical company or CRO
• At least 4 years of monitoring experience
• Ability to effectively conduct clinical studies and develop the pipeline
• Maintaining local regulatory and compliance requirements in countries
• Ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support
• Strong understanding of local regulatory environment
• Ability to identify problems, conflicts and opportunities early and lead
• Communication and empathic skills
• Ability to coordinate and lead local teams to high performance
• Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters in a timely manner using approved Novella/sponsor forms and reports
• Authorized to request site audits for reasons of validity
• Understanding of basic data processing functions, including electronic data capture
• CM_Data_Cleaning_Report_By_Site and CM_Data_Cleaning_Report_By_Subject both Business Objects reports
• Reconcile patients that have come off treatment and off study
• Generate and review various IL2 reports
• Works closely with CDRC to ensure data is further reviewed and discrepancies documented
• The Technical CTM may participate in CDRC review and aid in Patient Profile review, as necessary
• There may be additional tracking required as a result of CDRC’s review
• Support all clinical research activities essential to the successful management of pre and post –market clinical studies under the direct supervision of clinical project manager or clinical affairs director
• Maintain and track data of the clinical studies including investigator selection, analysis of potential patient recruitment, and overall study status/progress throughout the life of a study
• Manage site start-up/activation process, including: preparation of study related documents (protocols, case report forms/eCRFs, Informed consents, Clinical trial agreements), organizing IRB/EC submissions and applicable regulatory documentation with follow through to ensure successful outcomes
• Amends clinical study documents as needed
• Monitor (remotely) clinical study data entered in an Electronic Data Capture (EDC) system or paper case report form at sites to ensure regulatory and protocol compliance as well as overall accuracy
• Serve as main liaison to participating clinical trial sites with focus on data entry, query resolution and overall site activity
• Conduct clinical study site monitoring, as required
• Provide project administrative support including maintenance of study documentation (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.) and, as required, prepare clinical summaries
• Oversee purchase order process and invoice reconciliation for clinical studies as well as the Clinical Affairs department, including working with accounts payable and external parties
• Assist Clinical Project Managers with development of Clinical Evaluation Reports (CER), including evaluating and summarizing Medical Device Vigilance Reports (MDVRs) and assisting with clinical literature search and appraisal
• Partner with Clinical Project Managers on study scoping activities, including but not limited to development of pre-study questionnaires, study design and surgeon/site selection
• Lead clinical quality initiatives including internal compliance audits of current clinical studies, and review of quality system documents including DOPs, SOPs and Work Instructions
• Possess basic knowledge of Good Clinical Practice and 21 CFR Part 11 and international regulations
• Bachelor’s degree in scientific field required
• Clinical research/clinical trial management certification/education preferred
• Must be Clinically savvy
• Experience in clinical trial management preferred (2-4 years)
• Must be able to travel up to 10-20%
• Good communication and interpersonal skills with high attention to detail and organization
• Basic medical writing skills preferred
• Proficiency in Microsoft Office, including Word, PowerPoint, Visio and Excel
• Experience working with electronic data capture systems
• Experience in medical device industry required
• Conducts periodic site file audits to ensure compliance with GCPs and Novella standard operating procedures
• Assists with, attends, and may present at Investigator Meetings for assigned studies
• Performs study close-out visits
• At least four years experience in monitoring clinical trials preferred
• Excellent organizational and interpersonal skills
• Able to mentor other CRAs on project team and co-monitor as required
• Computer literacy and knowledge of electronic data capture preferred
• Must be able to travel domestically and internationally 50-75%
• Monitoring of moderately complex clinical experimentation including data collection, summary and thorough analysis, in support of department research projects and guidelines. Compose robust experimentation strategies that maximize effective use of resources and time to deliver optimum information
• Apply knowledge of FDA regulations to site monitoring and clinical study design duties
• Apply knowledge of Alere products to effectively train clinical sites before study initiation
• Generate oral and written reports as necessary and to summarize clinical investigations and projects. Initiate communication with related staff and functions as necessary to coordinate activities effectively
• Provide recommendations and observations to senior scientific staff on results of projects/tasks. Play a major role in the formulation of research strategies and tactics
• Interact with study coordinators at clinical sites to ensure optimal study progression and resolve problems. Pro-actively recommend strategies to overcome hurdles
• May functionally direct junior staff as required
• Initiate literature review and searches to support ongoing research activities. Summarize findings in a final form to senior staff and recommend follow-up actions
• Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
• Position Title: Clinical Research Associate
• Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct
• Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented
• Ensures site staff complete the data entry and resolve queries within expected timelines
• Ensures accuracy, validity and completeness of data collected at trial sites
• Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints
• Fully documents trial related activities in particular monitoring. Writes visit reports and uploads into eTMF within 5 working days for review and approval. Complete follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team with 15 working days. Promptly communicates relevant status information and issues to appropriate stakeholders
• Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team
• Attends regularly scheduled team meetings and trainings
• Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g…,OSQMV
• Prepares trial sites for close out, conduct final close out visit
• Negotiates investigator budgets at site level, if applicable
• Tracks costs at site level and ensure payments are made, if applicable
• Leads and/or participates in special initiatives as assigned
• May assume additional responsibilities or special initiatives such as “Champion” or Therapeutic Area Expert”
• Position Title: Lead Clinical Research Associate
• Sector: Janssen
• Collaborates with the CPL, GTM, local management/Country Head and Protocol Owner to select final site list
• Contributes input to the development of Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial
• Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting
• Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate
• Maintains and updates trial management systems - (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints).Uses study tools and management reports available to analyze trial progress
• Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams
• May submit requests for vendor services and may support vendor selection
• May lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines
• Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting
• Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes)
• Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the GTM and FM as needed
• Reviews and approves site and local vendor invoices as required
• Works with SM to ensure CAPP is implemented for audits and inspection or any quality related visits
• Complies with relevant training requirements
• Act as local expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams
• Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs Trials
• Actively contributes to process improvement; training and mentoring of Clinical Trial Administrators, Site Managers and other LTMs
• May represent functional area in process initiatives
• Contributes to optimization of daily processes
• Regularly represents department in team meetings, leads teams and drive collaborative efforts (e.g., protocol development, CRO selection, etc.)
• Oversees and is accountable for feasibility assessments for new studies
• Responsible for TMF contents and accountable for TMF reconciliation
• Oversees and is accountable for
• 2-4 years industry experience, including a minimum 4 years clinical research experience
• Competent in the skills for the CRA II and the following
• Maintain IRB documentation for clinical studies related to product development
• Maintain clinical sub-study documentation
• Coordinate and run in-house clinical studies, including recruitment of subjects, testing of subjects and completion of clinical report forms and IRB forms
• Collaborate with the various project heads to design, plan and write protocols and SOP’s for in house studies
• Conduct clinical studies ensuring compliance with the company’s SOP’s, IRB rules and standard clinical practice
• Create and maintain and organize accurate study documents, logs, and binders
• Prepare status reports, track progress and provide clinical feedback to project heads and team members
• Maintain the viability of the physical set-up of the clinical lab, ensuring the safety and comfort of the subjects and all personnel who conduct and participate in study testing
• Assists with site initiation, training and monitoring of external study sites and Beta sites as needed
• Conduct clinical audits as necessary to support clinical studies, both internal and external
• Participate as a member of Project Teams, as assigned
• Prepare various clinical operation metrics and analytical reports; prepare abstracts/articles for investigators involved in ResMed's clinical studies; develop clinical study protocols and amendments
• Develop and conduct presentations with designated groups, including investigators meetings, site personnel and internal ResMed teams
• Development of study related documents according to study requirements, such as informed consent forms, case report forms, source documents, logs, newsletters, etc
• Provide forecasting of clinical supplies with updated projections based on actual study information after study initiation
• Conduct clinical study visits (site qualification, site initiation, interim monitoring and close out) in accordance with Good Clinical Practice (GCP), ResMed work instructions (WIs) and all state and federal regulations
• Conduct potential site interviews and complete site selection process
• Coordinate and participate in investigator meetings, site initiation and training of site staff
• Collect and track regulatory documents (clinical trial research agreements, investigator's agreements, CVs, NDA, etc) for clinical studies per ResMed WIs
• Assure clinical studies are conducted in accordance with the protocol, GCP, ResMed WIs and all applicable (e.g. FDA) regulations
• Implement strategies for enrolment to ensure timely completion of clinical studies, in alignment with department and corporate strategic objectives (newsletters, conference calls, emails, etc)
• Maintain up-to-date site and in-house regulatory documentation for the Trial Master File
• Assist Medical Affairs management in the processing of adverse events, protocol deviations, and technical observations
• Conduct data management activities (second review of CRFs, query processing, data analysis, etc)
• Ensure adverse event, technical observations and protocol deviations are completed in accordance with ResMed WIs
• Assist with posting and management of clinical studies on clinicaltrials.gov
• Assist with the resolution of audit findings
• Provide study summaries for Medical Affairs management, including reports, graphs and tables, as requested
• Support budget and contract negotiations with clinical sites
• Assist with selection of vendors and contractors, as needed
• Assist with regulatory submissions, which include annual report, 510(k), PMA, and IDE submissions
• Manage the operations of a clinical study, including newsletters, site conference calls, communication with investigators and study staff
• Develop and manage tools/metrics for study progress (e.g., timelines, enrollment goals/graphs, etc)
• Follow FDA and international regulations pertaining to medical devices and industry guidelines related to regulatory submissions, institutional review boards (IRB), clinical investigations, monitoring procedures and medical device reporting
• Review clinical publications
• Achieve high level of clinical expertise in various therapeutic areas and procedures associated with ResMed projects
• Maintain knowledge base of clinical regulations for conducting trials
• Develop and revise departmental procedures
• Strong analytical, organizational, and communication skills
• Outstanding time management and organization skills
• Track record of successfully managing a team
• Confident team leader and team builder with strong motivational skills
• Adept in problem solving and resolving conflict
• Able to manage internal customer relationships and expectations
• Ability to travel 30-40% of the time
• Must have excellent organizational skills and take ownership of work
• Experience in communicating with all levels of management
• Bachelor's Degree in Medical Science, Science or Life Science degree required; Masters degree in a relevant field preferred
• Must have a minimum of 3 years of experience in clinical study support as a Clinical Research Associate (CRA) or Clinical Research Coordinator
• Medical device study experience preferred and/or clinical experience in healthcare preferred
• Knowledge about the practice of sleep and respiratory medicine a plus
• Proficiency in Microsoft Office (Word, Excel, Power Point, Visio or equivalent flowcharting software, and Outlook) and Internet searches
• Experience in relational database system such as Microsoft Access and publishing software such as Microsoft Publisher is desirable
• Experience with electronic data capture systems is desirable
• Serves as a trainer for contract research organizations (CROs) needed for additional monitoring support
• Ensures timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations
• CORE LAB MANAGEMENT EXPERIENCE IS REQUIRED FOR THIS POSITION
• Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study-related documentation, and organize meetings and other tasks as instructed by supervisor
• Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
• Assist with training, mentoring, and development of new employees, e.g. co-monitoring
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
• CRA II positions require 2+ years of clinical research monitoring experience
• University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
• In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered
• Essential for candidate to have sound oncology experience
• This position may also be at the Sr. or Prinicipal CRA level depending upon the selected candidate's experience and skillset
• Demonstrate strong problem solving skills
• BS / BA in a related scientific area
• Minimum of 3-6 years of field monitoring experience
• Medical device experience preferred, but not required
•  Be primary point of contact for sites
•  Build and maintain relationship with sites
•  Monitor sites (Initiation Visits, Routine Visits, Close Out Visits, etc)
•  Produce monitoring reports within SOP and monitoring plan timelines
•  Coach investigators to be compliant with GCPs and the protocol
•  Talk to site staff about site recruitment
•  Ensure sufficient drug supply on site and reconcile drug on site
•  Ensure high quality data and conduct at sites
•  Identify and escalate issues or concerns to the internal Amicus team
•  Identify, analyze problems and trends; provide and recommend solutions across studies
•  Acts as liaison between CRO CRAs, Field Based CRAs and the PM
•  Accountable for reviewing and approving all trip reports for assigned studies
•  Develop training tools and training materials in support of the project
•  Develop study tools for sites and CRA use
•  Accountable for the quality of the trip report content
•  Facilitate the review and provide input to the Monitoring Guidelines
•  Co-monitor with 3rd party CRAs as needed
• 4+ years experience from similar work within a pharmaceutical company or CRO is preferable, but can also have experience as a research coordinator
• Team player with a positive attitude
• Self-motivated and able to function with little supervision
• Highly detail-oriented
• Superior communication skills, both verbal and written
• Able to resolve conflicts in a diplomatic manner
• Solid problem-solving and decision-making skills
• Understanding of SOPs, WIs, FDA and local regulations as well as ICH-GCP guidelines
• Demonstrates ability to prioritize and manage time for the preparation, completion and follow up of monitoring tasks
• On site experience with most types of visits; PSSV, SIV, IMV, COV
• Thorough knowledge and application of project specific
• Bachelor’s degree – Life Science preferred or
• Consistently meets or exceeds metrics for quality trip
• Assists with the review of protocols, informed consents, and study related documents
• Maintains and tracks regulatory files/essential Master Documentation Files (MDFs) while working closely with other team members to ensure these documents are properly managed and are accurate
• Interacts and supports internal and external personnel to facilitate meeting project timelines and tasks in accordance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and all applicable regulatory guidelines
• Supports Leidos CRAs and Project Managers with clinical site management
• Assists with managing the relationship between Clinical Research Organizations (CROs) and field CRAs, as needed
• Assists with investigator site activities in adherence to all applicable guidelines, including GCPs and SOPs
• Ensures appropriate reporting of Adverse Events (AEs), Serious Adverse Events (SAEs) and unanticipated problems
• Assists with the review and possible design and production of subject Case Report Forms (CRFs) and performing quality control on completed CRFs
• Assists with clinical trials progress
• Participates in and helps organize clinical trial activities with CROs, such as investigator meetings, study initiation, ongoing monitoring and close-out visit activities when applicable
• Assists in preparation and production of documents for Food and Drug Administration (FDA) submission, as well as annual IND protocol reports
• May assist in conduct of site visits and initiate draft reports and letters in a timely manner to ensure compliance with SOPs
• May require local travel 5-10%
• Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research, clinical trials and/or health, or four (4) years related experience in lieu of degree
• Ability to prioritize multiple tasks/projects through effective organization/planning skills
• General knowledge of clinical trial fieldwork concepts and practices, FDA regulations and GCPs
• Knowledge of database management
• Must be willing to travel approximately 5 -10% local/domestic
• Infectious diseases experience
• Prior experience as a Clinical Research Associate
• Must have demonstrated problem-solving abilities in overseeing clinical sites, and demonstrated tactfulness and diplomacy in dealing with study coordinators and physicians
• Able to resolve routine issues independently
• Knowledge of regulatory environment (ICH-GCP, relevant European and German laws)
• Prior hematology / oncology clinical study experience
• Driver’s license
• Provides clinical trials monitoring for NIAID and for a large network of clinical sites participating in Investigational New Drugs (IND) and non-Investigational New Drug (non-IND) protocols
• Ensures sites are following U.S. Food and Drug Administration (FDA) regulations for INDs, Investigational Device Exemptions (IDEs), International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines, and other applicable regulations
• Monitors the source documentation for the appropriate reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Critically evaluates clinical trial data for accuracy and completeness while ensuring the safety and confidentiality of participants
• Provides assistance and monitoring of pharmacy records, including receipt, storage, labeling and final packaging, inventory, distribution and the processing and disposal of returned investigational agents according to the study monitoring plans and Standard Operating Procedures (SOPs)
• Assists the Clinical Trials Management (CTM) team in maintaining relationships with site staff and/or network entities, Clinical Research Organizations (CROs) and field CRAs
• Assists with the design, planning and implementation of clinical trials including protocol and Informed Consent Form (ICF) reviews
• Coordinates project activities associated with monitoring functions of clinical studies for domestic and international sites and provides assistance to the clinical investigators and teams to reinforce and enhance a GCP culture
• Conducts site study initiation, monitoring and close-out visits, completes reports in a timely manner
• Ensures the conduct of the trial is in compliance with Standard Operating Procedures (SOPs) and GCPs, the approved protocol/amendment(s), NIAID Institutional Review Board (IRB) and NIH policies, and applicable regulatory requirements
• Maintains Essential Documentation File contents, ensures accuracy and completeness of documents and reconciliation of the documentation
• Assists other CRAs and Clinical Project Managers in working with investigators to generate and/or revise study-related documents
• Assists with ensuring that the required approvals to initiate intramural research are in place
• Assists in the preparation and production of documents for FDA submissions, as well as IND annual protocol reports and manuscripts
• Reviews or helps create internal and/or external SOPs, guidelines and tools for the CTM team in support of NIAID staff
• A minimum of two (2) years of progressively responsible experience in biomedical research including a minimum of one (1) year directly related to overseeing multiple concurrent trials
• A minimum of one (1) year on-site clinical monitoring or site management experience
• Ability to prioritize multiple tasks/projects, accomplish goals and meet expected timelines through effective organizational and planning skills
• Ability to communicate effectively with non-technical and technical staff
• Knowledge of clinical trial fieldwork, monitoring concepts and practices, FDA regulations and ICH GCPs
• Proficiency with Microsoft Office products including Microsoft Word and Excel
• Experience with electronic or remote data capture monitoring as well as paper based monitoring
• Ability to travel approximately 30-40%
• Must be able to obtain and maintain a security clearance
• Familiarity with regulatory requirements and guidelines for clinical research, as well as monitoring requirements to ensure integrity of data and site compliance
• Experience in the development of case report forms, manual of operations and study monitoring plans
• Experience with database management such as TrackWise®
• Ability to read French or Spanish
• To ensure that clinical studies are conducted at investigator sites in compliance with the current approved protocol and any protocol amendment(s), ICH GCP, GSK Written Standards and applicable local laws and regulatory requirement(s) so that the rights, safety and well-being of human subjects is protected and that the reported study data is accurate, complete, and verifiable from source documents
• Fully accountable for ALL aspects of site management including ensuring completion and delivery of all local activities required to ensure high quality set up, execution and completion of studies. Ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met. In addition to the monitoring duties of a CRA, the Senior CRA will demonstrate the ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity
• Communicate progress and relevant study information or escalate issues of the study to the local study management team and other key stakeholders e.g. CRA Manager
• Responsible to contribute to the wider business by taking on leadership roles representing monitoring interests on internal and cross functional process improvement teams, standardizing processes, identifying and sharing best practices and continuous improvement
• Act as a role model, coach, mentor for new or less experienced CRAs on processes, study, technical and behavioural competencies including resolving difficult situations
• Build effective long-term collaborative relationships, and to uphold the reputation of GSK
• Ensure the quality and integrity of clinical studies conducted in the LOC by taking on appropriate business management monitoring activities as agreed with local Quality and Training Manager
• Provide training and monitoring support for new and less experienced CRAs, ensures competency of less experienced CRAs by participating in joint site visits or co-monitoring visits
• Take a leadership role in standardizing processes within and across LOCs, identifying and sharing best practices and continuous improvement
• Provide leadership in resolving complex monitoring issues through discussion with other CRAs, local study management and other GSK departments as appropriate
• Performs operational site evaluation visits, study initiation visits, on and off site monitoring visits at the required frequency, and site closeout visits
• At site evaluation visits, determines the feasibility of conducting protocols with reference to study complexity, staff availability, clinical facilities, potential for recruiting patients, site selection and ability to comply with ICH GCP investigator and GSK requirements for clinical studies
• Deliver appropriate training to site staff and other relevant parties, as required. Assists with web based and face to face GSK trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinical study
• Participate in global investigators / monitor meetings as appropriate, facilitates investigator’s participation in global meetings and/or assist LSM with organising local investigator meetings
• Participates in other study meetings as required
• Assist the LSM / LCSS with site budget negotiation, the preparation of contracts and agreements with investigators, hospitals, pharmacies, labs, etc. using contract templates to run the studies in line with GSK and all regulatory requirements
• Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP)
• Completes monitoring visit reports within the agreed timelines
• Accountable for tracking and managing study related payments to investigational sites
• Ensure sponsor study records are inspection ready at all times and archives records as applicable
• May take on role of local expert/champion or subject matter expert in a business system / process
• Assists with audits/inspections of local clinical operations department & study /sites in the country
• Acquire and maintain an appropriate level of knowledge on the pathology of disease area being studied, the study compound, the study protocol and all study related activities
• Attendance at internal project meetings and relevant training courses. Participate continuously in relevant training courses to improve personal / professional skills
• Keep up to date with all the changes / required knowledge on ICH GCP, GSK written standards and attending appropriate training sessions
• Ensure the fulfilment of objectives protocol conform concerning enrolment, patients , centres, timelines defined in the protocol (number of patients and centres, timelines
• Ensure that ICH-GCP, corporate & local SOPs, and local regulations are respected and followed by all parties
• 4 years of CRA experience, at least 1 year of LCRA or CTL experience
• Advanced site monitoring skills
• Advanced study site management skills
• Advanced registry administration skills
• Advanced verbal and written communication skills
• Assists the trial manager in all aspects of trial development and initiation such as contract management, payment tracking, remote monitoring, study binder management and regular reporting to all active sites. Ongoing responsibilities to include
• Ability to foster positive working relationships with a wide variety of internal and external personalities
• Demonstrates a drive for continuous learning and continuous improvement
• Balances an attention to detail with the overarching strategy
• Knowledge of regulations governing clinical studies including GCP (Good Clinical Practices), PHRP (protecting human research participants), and HIPAA principles
• Capable of learning new software packages as required
• B.S. Degree in the health, life sciences, or engineering disciplines, or equivalent experience plus 3-5 years experience working in a clinical research environment, or an equivalent combination of education and experience
• Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification). Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. Maintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Manages investigator payments
• Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials
• Manages the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System)
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts
• Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members
• Other project work as assigned
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Unlike some CRA roles you will not be pushed to satisy unrealistic 'monthly visit' targets
• Join a stable team of CRAs across Switzerland and benefit from outstanding training and development, both initially and throughout the year
• Join a company where people tend to stay for 6-10 years rather than 1-3 years!
• Monitor, track and manage all study related tasks at study sites ensuring compliance with GCP, ICH, applicable regulations and company SOPs
• Requires a Bachelor’s degree (BA, BS or BSN) from a four-year college or university in a scientific discipline or equivalent combination of education and work experience
• 2 to 3 years of experience as a field based Clinical Research Associate required
• Must be Bilingual (French and English)
• Nursing or health care related experience helpful
• Attention to detail and the ability to prioritize
• Strong organizational, planning and follow-through skills. Ability to work well under pressure and with tight schedules. Self-direction and motivation are mandatory
• Ability to exercise judgment within well- defined practices and policies for obtaining data
• MS Word, Excel, knowledge of other presentation programs a plus
• Must be able to travel with overnight stays both Domestic and Internationally
• Consistently displays excellence in communication skills of a top level CRA
• Exhibits ability to identify and interpret problems, recommend creative solutions, and influence appropriate changes
• Demonstrates ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity
• Solid awareness of site dynamics and demonstrates ability to motivate, persuade, and educate site personnel
• Minimum of 5 years of clinical related experience, of which at least 3 years must be in clinical research monitoring
• Strong site management and monitoring skills
• Experience in multi-therapeutic areas desired
• Excellent knowledge of regulations governing clinical research, ICH/GCP Guidelines and/or federal regulations, and applicable local regulations
• Collaborates with Clinical Research Team to drive successful execution of global investigations
• Assist in protocol feasibility analysis, country assessment, site identification, and patient recruitment and planning
• Collaborates with Clinical Research Team to drive patient recruitment
• Independently performs monitoring visits, including site qualification, study site initiation, routine monitoring and study site closure visits
• Establishes and maintains regular contact with investigators, ethic committees, vendors and study sites to ensure legal compliance and assessment of accruals rates
• Assists in investigation start-up activities including site selection and review of regulatory documents and ensures site is qualified for the study
• Communicate project-specific information to/from trial sites and documents communication with investigations site/teams and escalate issues to team in a timely manner
• Ensure the reporting of high quality data and timely query resolution
• Maintain documentation for investigation sites as stipulated
• Presents at and participates in investigator meetings, other study trainings and meetings as required
• Maintaining current professional knowledge base of clinical research methodologies and FDA/EMEA requirements
• Support statistical evaluation of study results within the clinical research department
• Screening and identifying of business and product relevant scientific literature
• Assumes accountability for individual role responsibilities as articulated by supervisor
• Liaises with CROs and third parties related to the clinical study
• Effectively manages time to meet project deliverables and deadlines in a manner that minimizes rework
• Takes appropriate care to ensure quality of data
• Keeps team and supervisor informed and up-to-date on information directly related to own position in the clinical operations study team
• Minimum of college degree in a relevant discipline. Bachelors degree in relevant scientific discipline preferred
• 2-5 Years industry experience
• On-site Monitoring
• Clinical Research responsibility for marketed products, product modifications and/or assigned new product programs (NPI)
• Preparation of clinical protocols, study documentation and clinical reports
• Development and maintenance of claim sheets to support sales and marketing
• Use knowledge to trouble shoot and investigate issues with assigned products and processes to provide resolution
• Bachelor's degree or higher in a science related major from an accredited institution
• Minimum of two (2) years microbiology laboratory experience
• Minimum of four (4) years of clinical research experience
• Master’s degree in science related field from an accredited institution
• Certification as a clinical research associate (CRA)
• Experience in one or more of the following areas: vascular access research, wound care research, skin research
• Experience and knowledge of ICH and FDA guidelines
• Experience working with customers in understanding/documenting voice of customer and user requirements
• Excellent ability to multi-task and prioritize
• Ability to work effectively on cross-functional teams
• Be responsible for all aspects of site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical Investigator sites within the approved Clinical Development Plan (CDP). These global, complex studies are conducted within the standards set by Bayer Global Development, according to Good Clinical Practices (ICH - GCP) and applicable regulatory and legal requirements
• Manage Investigator site and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs
• Manage Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out
• Conduct Site Selection Visits to confirm the Investigator and Site Staff are qualified, and have suitable resources and facilities to properly conduct the study
• Ensure completion of site documents necessary for ethics and regulatory approval for site initiation within agreed upon timelines. Ensuring all legal, regulatory and Bayer requirements are met prior to drug shipment to sites as well as all site initiation processes are completed
• Ensure Investigator Agreements and budgets are negotiated and executed for assigned study sites, and subsequently initiating payments at key milestones
• Train and supervise cross functional site personnel on study related procedures for the duration of the study
• Bachelor’s Degree (or equivalent)
• 6 – 7 years of relevant healthcare experience including 4 years of monitoring & site management experience
• In-depth knowledge of the drug development process including monitoring and site management, local and international regulations, ICH – GCP, drug safety requirements, data management processes and investigator grant parameters
• Awareness and understanding of cultural differences as well as regional operational differences and budget management
• Effective written and verbal English communication skills, strong oral presentation, interpersonal, decision-making and issue resolution skills are required
• Effective planning and organization skills, attention to detail and excellent follow through
• Advanced degree or Bachelor’s degree in a biologic discipline with equivalent job experiences required; pathology or IVD experience preferred
• 8+ years of Clinical Trial Management experience for medical device, pharmaceutical or biological products; experience in diagnostics preferred
• A solid understanding of clinical project management and familiarity with project management tools
• Understand and have experience related to the regulatory requirements of China controlling bodies and framework as regards IVD development
• Knowledge of pathology and/or oncology is necessary
• Experience in working in parallel project teams
• High work capacity is required at certain times in high priority projects
• Experience in CRO/vendor management and contracting is preferred
• The ability to organize and motivate others
• Bachelor’s degree, preferably in a life science or scientific related field, or RN or BSN degree or 10+ years of recent and relevant clinical research/monitoring experience
• Four year or more experience in clinical research, with a minimum of two to four years’ experience in independent coordination of investigational site activity by on-site monitoring and site communications
• Intermediate knowledge and understanding of FDA regulations and ICH – GCP guidelines
• Must work both independently and in a team environment
• Proven track record of on-site monitoring of investigational sites and constructive site collaboration
• Ability to review and interpret medical records through knowledge and general application of medical terminology
• Excellent interpersonal, written communications, time management, and organizational skills
• Detail oriented with good problem solving skills
• Ability to manage multiple tasks and take ownership and workflow initiative
• Proficient computer skills using Microsoft Office products
• Experience with electronic data capture (EDC) is a plus
• Presentation skills desired
• Leading problem solving and resolution efforts to include management of risk, contingencies and issue resolution
• Developing study management plans, together with team assignments and accountabilities and oversight of database maintenance
• Ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures
• Continuously assess site performance, processes, qualifications of staff, and suitability of facilities to ensure adherence to study protocol, Bayer Healthcare requirements, regulatory and local legal requirements, as well as ICH-GCP
• Track to ensure sufficient resources at site to conduct study activities for duration of the study
• Track enrollment activities to ensure site remains on track with site commitments and develop contingency plans to ensure site commitments are met
• Review patient data at site to ensure safety of patient and patient data is consistent with what is reported in the case report form. Serve as liaison between Investigator and Study Medical Expert to resolve any medical patient-related queries. The data from these clinical sites are required to demonstrate patient safety and efficacy of investigational products which forms the basis of regulatory approval
• Assure adequate control of investigational product (study medication), which includes: ensuring sites have met all local and legal requirements to receive investigational product, study drug storage, and continually ensuring patient compliance with expected study drug dosing. The Sr. CRA is responsible for study drug accountability at the site level and arranges for destruction of investigational product in accordance with local legal and regulatory requirements
• Ensure applicable authorities are notified of study closure and final patient status in accordance with ICH and local regulations
• Periodically review Investigator Site File to ensure essential documents are maintained according to ICH and SOP requirements
• Understand that rigorous regulatory guidelines exist to ensure overall patient safety related to reporting of serious or unexpected adverse drug reactions. The Sr. CRA is responsible for training the Investigator and site staff on these strict regulations and procedures for timely reporting and as well as monitoring ongoing compliance. Strict adherence is essential to remain compliant with on time reporting from Bayer to regulatory authorities and critical for thorough and timely evaluation of patient safety
• Proactively identifies potential issues and develops site Corrective Actions / Preventive Actions (CAPAs) Plans. The Sr CRAs ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data
• Ensure essential documents are appropriate and filed in a timely manner in the Investigator Site File as this role is a key contributor to the Trial Master File and study documents at the country level
• Be a key contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to ensure a successful outcome. The Sr. CRA is a member of the audit/regulatory inspection team
• Be a mentor and role model for new or less experienced CRAs on process, study, technical or behavioral competencies. The Sr CRA may also conduct co-monitoring visits as defined in the Study Oversight Plan to mitigate risks and ensure the quality and reliability of study data and processes. In addition, the Sr CRA may participate in Expert Working Groups for Global SOPs, training or process improvement initiatives
• Six (6) + years of relevant healthcare experience
• Four (4) years of monitoring & site management experience
• Effective written and verbal English communication skills, strong oral presentation, interpersonal, decision-making and issue resolution skills
• Coordinate with study investigators to plan and implement new research projects
• Assist with the design of data collection and tracking forms; develop and implement data tracking procedures
• Coordinate and serve as the liaison with other research sites
• Train and oversee data collection personnel; monitor quality assurance for data collection
• Manage study databases with assistance from programmers and statisticians; produce data reports for tracking purposes
• Perform other research related tasks, as needed
• Bachelor’s required; Master’s preferred
• Two to three years directly related experience; Certified Clinical Research Professional (CCRP)preferred
• Strong organizational skills, attention to detail and responsiveness to deadlines
• Ability to multitask, flexible, adaptable to change
• Knowledge of research methodology
• Ability to communicate effectively and tactfully with a variety of staff, faculty, researchers and business contacts
• Experience with oncology trials
• Word processing skills and familiarity with Windows-based software, Excel, Access, Power Point
• Manage and oversee multiple research projects involving human subjects, particularly medical patients
• Assist the Administrative Director with program planning, consenting of patients to research studies, IRB processing and compliance with federal, state, local and institutional research regulations
• Manage research budgets and contracts
• Supervise clinical research protocols and disease-related databases
• Maintain a collaborative relationship with Principal Investigators and inter-departmental staff
• May perform research project-related tasks such as subjects recruitment and data collection, as needed
• Maintain and manage a tissue and specimen data bank for thoracic surgery and oncology
• Two to three years directly related experience. Certified Clinical Research Professional preferred
• Ability to communicate effetively and tactfully with a variety of staff, faculty, researchers and business contacts
• Word processing skills and familiarity with Windows-based software, Excel, Access and PowerPoint
• Assists with the completion of activities regarding study execution; including working with functional areas and site monitors to ensure assigned activities are completed per plan. This may include assigned study region(s)
• May have at least 1 year Pharmarelated
• Demonstrates analytical and critical thinking skills
• Possesses good communication skills
• Identify potential investigators in collaboration with the sponsor
• Perform evaluation visits to assess facilities and staff so as to ensure the selection of appropriately qualified investigative sites
• Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted
• Perform monitoring duties as specified in the relevant procedures
• Verify data versus source documentation and validate CRF entries
• Generate and resolve queries as required
• Control investigational product accountability through physical inventory and records review. Control trial supplies ordering, dispatch, return and destruction, where applicable
• As necessary, prepare and submit regulatory, ethics committee and provincial applications and regulatory packages
• Ensure the proper essential documents are in place prior to trial start up and on an ongoing basis throughout the study - prepare Regulatory Compliance Review packages
• Ensure administrative set up of sites, laboratories, storage facilities, equipment, etc
• Organise and participate in investigator meetings as necessary
• Provide trial status tracking and progress reports as required by the Project Manager or Clinical Team Manager
• Administer investigator payments
• Conduct and ensure proper trial close out and retrieval of trial materials
• Archive relevant documents as per procedures
• Clearly document all observations in reports and letters in a timely manner, according to accepted business writing standards. Ensure that any serious issues are immediately raised to the attention of project management, clinical team management and clinical operations management in writing
• Maintain a working knowledge of GCP, Corporate global SOPs and applicable client SOPs
• Facilitate effective communication between investigational sites and the PPD project team through written, oral and electronic contacts
• Facilitate and respond to company, client and regulatory audits
• Contribute to the project team by mentoring new members, assisting in preparation of project tools and sharing ideas and suggestions with team members
• Bachelor's or higher graduate degree in a science related field, licensed or certified health care training or equivalent experience
• Possesses a Valid passport
• Knowledge and understanding of relevant regulations, e.g., ICH/GCP, FDA guidelines
• Basic computer skills and the ability to learn appropriate software
• Basic medical/therapeutic area knowledge and medical terminology preferred
• Ability to travel and spend 60 to 80% of working week at site
• A minimum of one to two years experience as a Clinical Research Associate / monitor or in a health sciences field / clinical research setting is required. Three years' experience for the Senior CRA role
• Under general supervision, follows established company policies and procedures and applies acquired job skills to…
• Performs functions that require full knowledge of general aspects of the job
• Works on assignments that are semi-routine in nature, but recognizes the need for occasional deviation from accepted practice
• Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation
• May provide assistance to A1 with more general support tasks that require a better understanding of functions, as directed by immediate supervisor
• May refer to A3 for assistance with higher level problems that may arise
• Escalates issues to supervisor for resolution, as deemed necessary
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations
• Utilizing defined guidelines and checklists, supports the FMS Clinical Studies Department CRO in the coordination, monitoring and tracking of clinical research studies, ensuring clinical activity receives appropriate Institutional Review Board (IRB) approval and is conducted in compliance with the designated protocol, the Office for Human Research Protections (OHRP), Good Clinical Practice (GCP) guidelines FDA regulations, and all applicable regulatory requirements
• Collects essential regulatory and other study specific documentation related to the assigned project including up to date medical licenses, Curriculum Vitae, certificates and IRB approvals and ensures they are adequately filed and maintained
• Ensures research activity has received all necessary IRB approvals
• Verifies the investigator is following approved protocol and all GCP procedures on an on-going basis
• Assists with PowerPoint training of investigative personnel on human subject protection, principal investigator obligations, GCP and local regulations to ensure sites are conducting clinical research according to protocol and regulatory requirements. Training may take place either at investigator meetings or at the investigative site
• Works with investigational site staff on an on-going basis to ensure submission deadlines for safety reports and annual reports are consistently met
• Manages the Trial Master File including the collection, review and ongoing maintenance of essential documents from Investigators, including ICF customization as well as the coordination of IRB submissions. Follows defined process/protocol to ensure the Trial Master File is ready for inspection by the FDA
• Establishes a strong working relationship with sponsors and investigational sites serving as the in-house site management primary liaison, resource and main line of communication for the studies
• Communicates effectively with investigational site staff maintaining a professional demeanor answering questions, investigating issues and triaging escalated issues as needed
• Performs site selection visits for newly selected sites; follows established checklists to ensure sites have all of the necessary staff, materials, pill counters and appropriate locked cabinets
• Works closely with study sites as needed ensuring Serious Adverse Events (SAE) are appropriately reported to the IRB in accordance with the study protocol and FDA regulations. Works with the Sponsor to ensure IND safety reports and alerts are distributed to all investigational sites and the CRO
• Provides support in the preparation of on-site regulatory agency and/or study sponsor inspections and audits as needed. May need to travel on-site responding to identified issues providing documents, study specific guidelines, procedures and to answer questions demonstrating the study is in full compliance with established protocol, GCP and regulatory requirements. Works with investigative sites to ensure they are always audit ready
• Creates and maintains clinical project documents including Monitoring Guidelines, Site Operations Manual and Monitoring Visit Letter templates under guidance of Project Manager/Clinical Team Lead/Director of Clinical Studies
• Collaborates with site staff to ensure Case Report Forms (CRF) are completed accurately and consistent with source data
• Assists with initial Investigator recruitment and evaluation by reviewing Site Feasibility Questionnaires and Investigator CVs. Final decision on Investigator participation is the responsibility of the study Sponsor
• If necessary, may assist field CRA with verifying source data, clinical notes and other trial records are accurate, complete and adequately filed and maintained at the investigational site
• Develops and maintains data collection/study tracking spreadsheets, tools and reports
• Establishes and maintains a filing and tracking system for electronic and paper clinical trial files and documentation including Confidentiality Agreements, vendor payments, site contracts, and milestone payments to support monitoring activities
• Assists with closing down investigative sites upon completion of the trial including essential document collection, transferring files to the sponsor or Iron Mountain and ensuring all unused trial supplies are documented and accounted for
• Makes a continuous effort to keep abreast of regulatory and scientific developments by attending training courses and reading professional journals and publications
• Facilitates trial-specific training according to industry standards for investigator and other site personnel and facilitates conferences for additional training as needed to ensure the successful conduct of the study
• Occasionally attends face to face Investigator meetings to present training on CRF completion guidelines, study specific procedures, guidelines and drug accountability
• Coordinates with the Sponsor, FMS Clinical Studies personnel and external customers to meet project specific goals including ensuring all sites are activated, have received IRB approval and study enrollment is on target to meet predetermined timelines
• 1 – 2 years’ related experience
• Minimum of 2 years experience in clinical research
• Clinical trials support or pharmaceutical industry experience preferred
• Prior experience and proficiency utilizing computerized information systems and MS Office. Ability to develop and maintain Excel spreadsheets
• Ability and willingness to travel up to 10% of time
• Knowledge of ICH and drug and device regulations that are relevant to clinical trials preferred
• Knowledge and experience in oncology trials is necessary
• Knowledge of GCP/ICH guidelines
• Ability to work independent to meet trial requirements and sponsor/contract deadlines
• Proficiency with computer systems and Microsoft Office Suite (Outlook, Word, Power Point, and Excel) required
• Attention to detail and demonstration of quick follow-up to study needs, commits to quality
• Interpersonal skills and clear oral and written communication skills. Uses correct grammar, syntax, and format
• Demonstrated adaptability, handles day to day work challenges confidently, is willing and able to adjust to multiple demands, shifting priorities; shows resilience in the face of challenges, demonstrates flexibility
• Shows work commitment: sets high standards of performance; pursues aggressive goals and works efficiently to achieve them
• Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing)
• Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives
• Report monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner
• Proactively identifies issues that may impact enrollment and recruitment timelines, and provide objective comments regarding these issues. Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines are met
• Prepares CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to
• CA and/or EC questions and related follow-up
• Certified Clinical Research Professional (CCRP) or Certified Research Associate (CRA) OR acquired within two (2) years of hire
• Human Research Subject Protection Course completion within three (3) months of employment
• Experience managing complex data
• Knowledge of Medical Terminology
• One (1) year experience in health care field
• Two (2) years administrative, data management or directly related experience in an acute care setting
• Experience building and managing databases
• Experience in Health Information Services
• Competent in use of office software to include Word, Excel, Access, Outlook, and PowerPoint
• Previous experience using Electronic Medical Records (EMR) such as EPIC
• Analytical skills and ability to resolve problems
• Working knowledge of data management programs
• May assist with orientation and training of new staff
• Minimum of 1-2 years of related experience OR completion of the CCPO New Staff Orientation program including completion of competency assessment
• Plans, conducts, and completes investigations under the supervision of the Clinical Research Director
• Assists with design and implementation of protocols utilizing vestibular equipment
• Assists with the preparation of technical reports, summaries, and protocols
• Implements and maintains the effectiveness of the Quality System
• Complies with all policies, established procedures, and regulations related to clinical research
• Actively participates as a member of the cross-functional project team
• With direction performs the following: - Assesses data generated by R&D/Business Teams
• Prepares design validation plans
• Prepares documents for clinical studies
• Proposes and negotiates budgets for clinical studies
• Initiates payments to sites
• Reviews data, prepares and presents clinical data reviews and data summaries
• Responds to audits and data queries
• Prepares the clinical sections of regulatory submissions and international registration packages
• Assists Regulatory in preparing responses to regulatory agencies’ questions regarding the clinical study
• Arranges for and assists in standard Statistical Support with the collection and statistical analyses of clinical data
• Monitors standard clinical studies ensuring site compliance with the clinical protocol and ICH/GCP guidelines, assures subject rights, safety, and welfare is protected, ensures data integrity through completeness, accuracy, and legibility
• Prepares and reviews product labeling and promotional materials
• Conducts standard pre-study, initiation, interim, and close-out monitoring site visits and completes site visit reports. Initiates standard clinical studies and provides for investigator and staff training
• Supports publication or presentation of clinical data in professional journals or meetings
• Maintains professional, product, and market expertise via independent reading, networking, and training
• Implements all policies, established procedures, and regulations into daily operations as appropriate
• Develops professional, expertise via professional and educational opportunities
• Assumes responsibility for attending training sessions, presentations, and continuing education sessions
• Works with assistance to prepare publications, abstracts,or presentations for professional meetings
• Contributes to goal setting
• Takes responsibility for achieving results
• Honors commitments
• Accepts and completes all management-directed work assignments such as clinical assignments, travel, and other tasks
• Demonstrates good basic writing skills. (i.e. clear, concise, effective, and well-organized) Demonstrates good presentation skills. (i.e. clear, concise, effective, and well-organized),Tries to understand changes in work tasks, situations, and environment as well as the logic or basis for change
• Bachelor’s degree or above of Medical Science, e.g. medical, pharmacy, nursing, etc
• Adequate English verbal and written skills
• Requires a minimum of one year clinical trial experience within pharmaceuticals industry or Contract Research Organisation; preferably in clinical monitoring. Other experience may also be relevant, e.g. as study staff at a clinical research site
• Knowledge of Good Clinical Practice (GCPs), International conference on harmonization (ICH) Guidelines, and local regulations, research process and scientific knowledge as relates to clinical trial conduct
• Bachelor’s or Master’s Degree in a technical area such as animal science, biology, veterinary technology
• Minimally two years of experience in a biological science area, a veterinary technician position, or research experience in an academic institution or the pharmaceutical industry
• Excellent organizational and interpersonal skills and very good written and oral communication skills
• Competence with multiple software platforms and data management experience
• Desirable: Experience and interest in working with companion animals. Previous experience in a research environment (GCP/GLP) and/or previous experience in diagnostic testing. Experience with electronic data capture and remote communication tools and skills. Experience working with production and research facilities
• Clinical study experience, data management experience
• Ability to work well with colleagues at all levels of the organization
• Ability to discern the appropriate communication type best to utilize given the situation at hand. For example, some colleagues can be helped over email or phone. Some require an office visit or Webex session to share the issues at hand
• Patience to work through complex issues with colleagues in multiple locations
• Strong Excel and Word skills
• Functions independently in a clinical research setting and is responsible for the complete coordination of the Center for Childhood Cancer Research biorepository study
• Will be expected to train, educate medical and clinical staff on the CCCR biorepository protocol and regulatory responsibilities, and interact directly with the investigative team
• Responsible for CCCR biorepository research activities, including (but not limited to)
• Informed consent process
• Submission of specimens/data and confirmation that all requirements met
• IRB submissions
• Completing chart abstraction for initial data submission and clinical updates
• Completion of data forms
• Assisting with budget development
• Coordinating obtaining specimens from central lab and transporting them for processing
• Working with the informatics and lab management systems teams to design and improve data collection
• Creation and editing of data collection forms
• Maintain open and frequent communication with inpatient and outpatient clinical teams
• Review sample information entered by the lab research assistant in lab management systems
• Responsible for meeting enrollment projections within study specified time lines
• This position will report to the CCCR Administrative Director of Research. and work closely with the Department of Pathology as well as leadership in the CCCR
• Must be knowledgeable on, have full understanding of, and promote good clinical practices (GCP) and will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources
• Provide leadership and direct responsibility for the implementation of study related activities
• Oncology and/or pediatric clinical research experience preferred
• Critical reasoning/problem solving skills to identify and resolve complex problems
• Manage Investigator site and site activities and monitor site data, to ensure patient safety and ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs
• Manage Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and commitments and to make certain the operational study execution is on track from site selection to site close out
• Six (6) years of relevant healthcare experience including 4 years of monitoring & site management experience
• Minimum of 1 year experience with In Vitro Diagnostic (IVD) products
• Experience in monitoring sites, excellent team skills, ability to prioritize and multi-task in a fast-paced environment
• Experience in the handling and shipping of Biohazardous specimens
• Familiar with clinical literature in field of study and related areas
• Works under moderate guidance and participates in the planning and implementation clinical research projects; contributes technical and clinical operations expertise
• May coordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well
• Travels to field sites to monitor studies
• Under moderate guidance; plans and prepares studies
• Manages training and coordinating certification of study site personnel
• Ensures site compliance with regulations and study protocol
• Monitors the sites and provides technical assistance, as necessary
• Manages material logistics for the studies
• Organizes investigator meetings, as necessary
• May act as a lead for assigned projects and/or Project Team Meetings
• Evaluates and escalates decisions impacting project team and/or work area(s) and/or broader organization
• Maintains a high level of professional expertise through familiarity with scientific literature, Company product portfolio, and competitve environments
• Processes and applies specific knowledge to the completion of difficult work assignments
• Field monitoring of studies and data collection for clinical trials with increased volume and moderate complexity, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
• Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g. Contracts), and recommend and develop basic process improvements
• Develop and deliver training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities
• May edit/amend informed consent documents
• Bachelor’s degree and 3 years previous industry clinical research experience OR Associates degree with 5 years previous industry clinical research experience
• Experience with electronic data capture preferred
• Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
• Moderate understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
• Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g., iMedidata)
• Excellent written and verbal communications skills
• Advanced problem-solving skills
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Conduct study feasibility assessment activities (if applicable)
• Develop key study plans and manuals as per the study team / project team charter
• Develop of critical study documents, such as study protocol, eCRF, ICF template, and others
• Identify CLO risks and mitigations and aligning with cross-functional Study Team on overall Risk
• Contribute to vendor evaluation and selection process
• Conduct day-to-day management of CRO and vendors’ contracted activities as per oversight plans
• Ensure final payments to vendors at study closure
• May collaborate with other functions as needed to support execution of CLO cross-functional activities, such as: user requirement specification review (IXRS, Global Labs, Specialties Labs), user acceptance testing, and data review
• Coach and mentor CTAs
• Determine clinical supply requirements, including ancillary supplies and comparator drugs
• Ensure compliance with ICH, GCP, SOPs during the execution of the study
• Contribute expertise to functional and cross-functional process improvement activities, as needed
• Execute on TMF maintenance
• 3-4 years of pharmaceutical industry or relevant experience
• 2 years of experience in a CRA functional role

Associate Clinical Research Associate Resume Examples & Samples

• With support, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
• Minimum of 2 years of clinical research experience (i.e. Clinical Trial Assistant, Study Coordinator, Regulatory Clinical Trial Coordinator or similar)
• Oncology Therapeutic Area experience
• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
• Hands on knowledge of Good Documentation Practices
• Developing skills in Site Management including management of site performance and patient recruitment
• Developing level of monitoring skill and independent professional judgment
• Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
• Effective time management, organizational and interpersonal skills, conflict management
• Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships
• Participates & provides inputs on site selection and validation activities
• Performs remote and on-site monitoring & oversight activities using various tools to ensure
• Minimum of 2 years of direct site monitoring experience in a Biopharmaceutical, Pharmaceutical or CRO company
• Travel: 65%-75%
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• Ability to understand and analyze data/metrics and act appropriately
• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
• A general familiarity with clinical trials research processes
• Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment
• Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP)
• Work habits include organization, coordination of many tasks, accuracy, and attention to detail

Clinical Research Associate, Melbourne Resume Examples & Samples

• Responds to company, client and federal regulatory requirements/audits
• Ability to attain and maintain a working knowledge of GCPs and applicable SOPs
• Ability to remain flexibile and adaptable in a wide range of scenarios
• Able to work within teams and independently
• Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity
• Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment
• Recognizes potential obstacles and works to resolve them within set timelines, takes responsibility for own actions
• Respects confidentiality in terms of PII
• Proactive, conscientious and precise in delivery of quality work even when under pressure
• Effective at analyzing and escalating issues, solving problems and resolving conflicts in a timely manner
• Flexible with high learning and change agility
• Knowledge of local regulations, IND/ICH GCP - guidelines, GSK written standards
• Available and willing to travel as job requires
• Strong computer skills with good eye for detail
• Acts as role model in line with GSK core values and behaviors
• Develops professional expertise; applies company policies and procedures to resolve a variety of issues
• Utilizes defined guidelines and checklists, supports the coordination, monitoring and tracking of clinical research studies, ensuring clinical activity receives appropriate Institutional Review Board (IRB) approval and is conducted in compliance with the designated protocol, the Office for Human Research Protections (OHRP), Good Clinical Practice (GCP) guidelines FDA regulations, and all applicable regulatory requirements
• Assists with PowerPoint training of investigative personnel on human subject protection, principal investigator obligations, GCP and local regulations to ensure sites are conducting clinical research according to protocol and regulatory requirements
• Organize and manage Investigator Meetings and study Kick Off Meetings. Ensure all participants are reimbursed for any expenses incurred
• Actively manages studies in Clinical Conductor Enterprise (CCE).This may include tracking CDAs, site contracts and milestone payments
• May be required to attend face to face Investigator meetings to present training on CRF completion guidelines, study specific procedures, guidelines and drug accountability
• Coordinates with the Sponsor, personnel and external customers to meet project specific goals including ensuring all sites are activated, have received IRB approval and study enrollment is on target to meet predetermined timelines
• Be available by phone to study Sponsor evenings and weekends when study Project Manager is unavailable
• May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor
• Assists with various projects as assigned by direct supervisor
• 2-5 years’ clinical research experience; or an advanced degree without experience; or equivalent directly related work experience
• Prior experience and proficiency utilizing computerized information systems and MS Office
• Disability Plans
• Voluntary Benefits Plans
• You have a bachelor’s degree or higher in medical science or other relevant degrees
• You are a strong communicator with a high level of energy and the ability to handle different priorities at the same time
• You have good understanding of current International Council on Harmonisation - Good Clinical Practice (ICH-CGP) and local requirements of clinical research
• You are able to create strong internal and external relationships and to drive positive team-spirit
• You come with a “can-do-attitude” and a structured approach to problem solving
• You are fluent in both written and spoken of English and Bahasa Malaysia at a professional level
• You are open to travel within Malaysia approximately 3 times a week
• Thorough knowledge and application of project specific protocol
• Consistently completes travel scheduling in accordance with project specific and UBC guidelines
• Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to Clinical Site Specialist/Regulatory Document Specialist for filing in Trial Master File according to UBC and/or sponsor timelines requiring minimal corrections
• Enters site visits, confirmation/follow-up letters and site monitoring reports into UBC’s Clinical Trial Management System
• Monitors within Electronic Data Capture data entry, if applicable, and assists sites with Case Report Form resolution
• Completes Regulatory Binder and Investigational Product reconciliation
• Thorough knowledge of International Conference on Harmonisaton, Good Clinical Practice guidelines, Code of Federal Regulations and UBC SOPs
• Responsible for providing coordination and support to all clinical operation team to ensure achievement of study goals, as well as tracking and maintaining study logistic information, systems and tools and appropriate study documentation in order to improve and maintain the quality and effectiveness of processes and activities in clinical operation in accordance with ICH GCP (Good Clinical Practice), local regulations, timelines and Company’s Standard Operating Procedure (SOP)
• Conducting activities related to start-up, on-going and close down phase. Including delivering training, site management, monitoring and support
• Ensuring management of invoices and payments including assisting as well as maintaining study payment trackers in Quantum
• Reconciling and tracking essential documents for the country level Trial Master File (paper or electronic) according to ICH-GCP and Roche procedures. This may include collection/retention/reconciliation of regulatory and investigator documentation, safety reconciliation, drug and non-drug reconciliation
• Ensuring documentation and archiving for all clinical study documents as per required in ICH –GCP, Roche SOP and Local Regulations
• Organizing and coordinating the logistic of internal and external meetings. These includes team meeting and external meeting, Investigator meetings
• Becoming co-monitor, as required and with appropriate oversight and training, during high volumes periods (eg. initiation visit, document reconciliation at study close-out) or when appropriate, to alleviate back logs in study workload which could potentially have a negative impact in achieving project
• Developing and maintaining functional knowledge of GCPs, Roche SOP and Local Regulations and therapeutic area (s) through continued training provided by APT or other function to ensure patient safety and data integrity
• Project manage all clinical trials, studies, limited market release projects responsible for
• Initiates writing of all study related documents and gathers feedback from cross functional teams
• Assists in writing and developing clinical protocols, data and tracking forms, informed consent documents, and clinical report forms
• Monitors and tracks patients at clinical sites
• Data collection of clinical research cases
• Track data report forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites
• Assists in writing annual and final clinical study reports
• Ensures accurate, up-to-date records of all documents and protocols of all clinical studies
• Ensures the effective fulfillment of objectives and deadlines assigned to the group
• Participate in proactive team efforts to achieve departmental and company goals
• Generate basic analysis of data and provide data analysis to outside consultant or internal Align Statistician
• Travel may be required – up to 40%
• Bachelor’s degree in Science or equivalent years experience
• 2-5 year experience as a Clinical Research Associate
• Highly recommended: Some orthodontic/dental knowledge
• Ability to give presentations and updates on clinical research
• Greater independence
• Limited supervision
• Ability to work on projects with limited training
• Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Good planning, organization and problem solving abilities
• Ability to work with minimal supervision Good communication and interpersonal skills
• Fluent in English and Spanish, both written and verbal
• Four years of direct experience in clinical biomedical and/or behavioral research required
• Must possess a current Tennessee State Board of Nursing license if primary residence is Tennessee or a Nurse Licensure Non-Compact state
• Must possess a current State Board of Nursing license in the state of primary residence if the state is a Nurse Licensure Compact state

Clinical Research Associate, Istanbul Resume Examples & Samples

• Determine protocol and regulatory compliance at the sites
• Life science degree – Pharmacy, Biology or other related
• In-depth understanding of ICH/GCP guidelines
• Experience with Oncology, Hematology or infectious diseases
• Excellent standard of verbal and written communication skills in English and Turkish languages
• Good organizational skills with strong attention to detail and deadlines
• Advanced skills across all of the Microsoft packages
• Perform on-site and remote monitoring and study closure activities across multiple protocols in a therapeutic area
• Proactively drive project success, including collaborating with cross-functional team members
• Ensure that sites operate in compliance with study protocols, SOPs, ICH/GCP guidelines, and Federal Regulations
• Interact with study management teams, Sponsors, and additional CRAs involved in projects
• Develop and maintain the department’s ability to produce infectious pathogens such as (but not limited to) human and rodent malaria, leishmania, dengue virus, and Zika virus. All tasks apply to production of any such pathogen, most of which are propagated concurrently within the lab
• Continually maintain parasite life cycle in animal models and mosquitoes or sandflies, to include multiple parasite species and strains maintained concurrently, resulting in hundreds of plates, flasks, and infected animals needing attention each day, depending on demand. Maintaining these cultures might require working weekends based on the number of cultures in process and external requests. The contractor will endeavor to improve efficiency, capability or capacity of new and existing culture methods and will keep abreast of current and emerging literature concerning parasite/viral propagation and culture
• Prepare vectors for infectious feeds and infect vectors using appropriate feeding devices, direct animal feeds, or injection methods. Feedings/injections will occur multiple times a week, sometimes several times a day, and sometimes on weekends, depending on demand. The contractor shall communicate with supervisors and other personnel to determine demand and adjust production and schedule accordingly
• Cultivate and continually maintain parasites, viruses, etc. in tissue culture and maintain laboratory records of parasite/virus growth and differentiation. The contractor will monitor parasite/virus development in infected vectors and in vivo animal infections by dissection and microscopic examination or molecular techniques, as appropriate, and maintain laboratory records of parasite/viral development and propagation
• Provide a final project record and report which shall include written reports, data summaries, troubleshootedand maintained databases, published research findings in peer-reviewed journals, and presented research findings at scientific meetings and conferences
• Be familiar with all cell culture, microbiological, molecular and other applicable techniques and methodology, Biological Safety Level 2 safety procedures, use of laboratory personal protective equipment, be familiar with WRAIR safety standard operating procedures (SOP), and attend WRAIR annual safety courses and other training, as offered
• Independently plan, execute and analyze basic research studies on the in vitro and in vivo cultivation of all parasite stages, viral propagation, vector-pathogen interactions, transmission biology and other applicable avenues of scientific investigation
• Assist in the preparation of infected vectors and execution of challenges for CHMI clinical trials according to protocol, schedule, and applicable regulatory governance
• Assist with the preparation and stewardship of laboratory reagents, methodology, equipment, biological materials and other materials pertaining to experiment execution and laboratory cleanliness and safety
• Work collaboratively to achieve the above. May require working evenings and weekends
• 2-5 years of related experience in scientific research, analysis and/or engineering
• Knowledge of developing and conducting experiments involving high complexity assays
• Understanding of microscopic examination of specimens, preparation of laboratory reagents, sterile techniques, and basic tissue culture techniques
• Assist with the study site selection process by preparing feasibility questionnaires and conducting site interviews by phone
• Develop various study specific forms/templates and prepares/ manages study status reports. Assist in vendor set-up, and oversight of vendors (including clinical CROs)
• Review essential documents from study sites for accuracy and completion
• Request set-up of TMF and review for reconciliation of required documentation
• Primary contact for coordination of protocol questions from CRAs and study sites: Answering purely administrative protocol questions according to level of experience
• Communicates all relevant and critical issues to management
• Maintains close liaison with research coordinators at clinical sites
• Assures compliance for assigned projects with clinical research policies and procedures
• Reviews study and investigator budgets
• This role is part of a career path advancing from CRA levels into Clinical Project Management over time
• Has ability to understand the disease under study and the aim of the therapy. Should be able to understand the relevant sections of the study protocol
• This position requires a sound knowledge of computer business software and meticulous attention to detail
• Monitoring experience is a plus
• Plans, implements and executes FDA registration studies to support clinical claims
• Supports the preparation of reports and summary documents (for internal and external customers) for product registration
• Assists team in budget and contract negotiations with study sites, central laboratories and CROs. Monitors adherence to the study budgets and timelines
• Conducts study start-up, monitoring and study close-out visits
• Ensures adherence to regulations, guidelines and departmental standard operating procedures
• Plans and prepares execution of studies through all phases of the study process
• Provides technical input to study designs and clinical development plans
• Reviews study protocols, reports and manuscripts
• Works with Data Management and Biometrics staff on the design of documents and processes for the collection of study data from participating sites
• Ensures study site compliance with Good Clinical Practices, regulations, SOPs and protocols
• Ensures accurate and complete study management/data collection and transfer into the data management system
• Acquires and maintains technical knowledge of product line
• Function as a research study project manager
• Participate in planning of company’s research studies
• Participate in writing study protocols and supporting documents, including case report forms and patient consent templates
• Participate in study site and investigator selection and qualification processes
• Represent company in interactions with institutional review boards for initial submission, continuing review, and regulatory reporting
• Manage preparation of the investigator binders, case report forms and other documentation required for the conduct of the clinical trial
• Manage setting-up study sites, which includes ensuring each site has the trial materials and training site staff on study protocols
• Develop monitoring and patient recruitment plans
• Monitor studies—visiting the study sites as needed
• Directly interact with investigators, study site personnel, and CRO personnel
• Verify that data entered onto CRFs are consistent with patient clinical records (source documents)
• Communicate with study site personnel to resolve data queries
• Collect completed CRFs from study sites
• Write and submit site visit reports and letters
• File trial documentation and reports
• Ensure accountability of study articles
• Close study sites as needed
• Archive study documentation and correspondence
• Communicate with company’s senior research personnel concerning problems and other relevant issues
• Bachelor’s degree in scientific discipline
• Ten years clinical research experience is preferred
• Five years clinical trial monitoring experience is preferred
• Certification as a Clinical Research Associate is preferred
• Experience working in medical device industry is preferred
• Familiarity with Good Clinical Practice guidelines, FDA requirements, and ICH guidelines
• Ability to multitask, manage multiple deliverables, and meet strict deadlines
• Knowledge of Microsoft Office programs, including Word, Outlook, Excel, and PowerPoint
• Conducts routine and for-cause quality assurance and monitoring activities (with the exception of investigator-held IND/IDE studies) and clearly documents findings related to work performed
• Minimum of 3 to 5 years relevant work experience in study coordination, research compliance, and/or conducting monitoring or quality assurance audits in the research setting
• Equivalent combination of relevant education and/or experience acceptable
• Demonstrated knowledge of applicable federal, state and local regulations and guidance documents, pertaining to research compliance
• Ensure that studies are correctly designed, coordinated, completed and analysed to provide the highest level of scientific evidence and more effective outcomes
• Develop and review trial protocols including literature searches of published articles
• Coordinate communication with the ethics committee and study sites, including completion of ethics application and associated governance documents
• Study planning and management of plan execution, in accordance with global study metrics
• Design the layout for data collection forms
• Setting up study sites, monitoring trials and closing down study sites
• Training of and liaison with clinical study personnel
• Budget preparation and reporting
• Verifying data
• Writing site monitoring visit reports
• Assisting preparation of and reviewing manuscripts for journal submission
• Hold regular update meetings and information sessions with marketing divisions on clinical studies
• Communication of trial activities to internal stakeholders
• Experience in Clinical Research in a similar medical environment
• Completed tertiary qualifications in science, allied health or a related field
• Exposure to clinical trials
• Be self-motivated and have the ability to work autonomously and within a team
• An attitude that thrives on achievement and in getting things done
• Minimum of three (3) years combined clinical research, biomedical and/or medical device industry experience (academic clinical research experience is considered qualifying)
• Bachelor’s degree or higher in Electrical Engineering or Mechanical Engineering from an accredited institution
• Experience working in hospital or clinical setting or medical laboratory
• Experience and knowledge of International Conference on Harmonisation (ICH) and FDA guidelines
• Ability to multitask and think on your feet
• Numeracy and attention to detail
• Ability to work effectively on global cross-functional teams
• 2 +years of laboratory experience in molecular biology assays
• Basic computer skills in MS Word, Excel and Outlook
• Associate or Bachelor's Degree
• Leads the conduct and oversight of clinical and human factor/ergonomic studies. Studies may be conducted as either Investigator Initiated or Sponsor initiated studies
• Responsible for compliance with procedures, federal regulations, and standards of Good Clinical Practice
• Maintains required documentation for studies including values for annual transparency reporting
• Performs scientific literature searches as needed to support team members
• Performs technical and medical writing; periodically author Clinical Evaluation Reports and White papers in addition to study protocols and reports
• Reviews and provides feedback on collateral material in development
• Support other objectives as needed for the clinical research department (i.e., procedure development)
• Contributes to the design of clinical studies
• Maintains familiarity with scientific literature, product portfolio and competitive environment
• Travels to clinical sites and conferences to meet with study Investigators and oversee clinical studies
• Reviews study protocols, reports and manuscripts. Contributes technical and clinical operations expertise for these documents
• Manages study inventory logistics and inventory tracking for studies
• Responsible for management of day to day activities of outsourced clinical site activities, including ensuring vendors meet related deliverables
• Maintains expertise in regulations for various types of studies (IDE, non-significant risk, feasibility, exempt, etc.) and serves as a resource related to clinical trial regulations
• Participates in site selection, qualification, study initiation, interim monitoring and closeout activities
• Ensures appropriate communication within and across functional groups
• Assist in the development of site budgets and may assist in budget negotiations
• Oversee clinical sites, partnering with monitors and site staff to identify and escalate or resolve compliance issues. Communicate any need for corrective action at sites
• Prepare and/or review trial-related documents including but not limited to Informed Consent Forms (ICF) and Case Report Forms (CRFs), site specific documents (informed consent template and study tools/worksheets), investigator contracts, and study milestone documentation
• Potential exposure to blood borne pathogens and other potentially infectious materials
• Accountable for execution and oversight of local operational clinical trial activities for assigned protocols in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally
• Ownership of country and site budgets; development, negotiation and completion of Clinical Trial Research Agreements; oversight and tracking of clinical research-related payments; payment reconciliation at study close-out; oversight and maintenance of financial systems
• Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols; development of local language materials including local language Informed Consents and translations; interactions with IRB/IEC and Regulatory Authority for assigned protocols
• Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments; responsible for quality and compliance in assigned protocols in country; contribution to the development of local SOPs; overseeing Clinical Trial Coordinators as applicable
• Coordinates and liaises with Country Research Manager, Clinical Trial Coordinator, Clinical Research Associate, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements and local milestones; collaborates closely with Regional Operations to align country timelines for assigned protocols
• Oversight and coordination of local processes; clinical and ancillary supplies management, im- and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management; enters and updates country information in clinical systems
• Bachelor's Degree (or comparable) in Business Finance/Administration/Life Science or equivalent Health Care related experience
• Requires expertise of core clinical systems, tools and metrics
• Excellent English skills required
• Strong coordination and organizational skills required
• Position requires extensive experience in clinical research operations and experience with project management and coordination
• Expertise of core clinical, regulatory and financial systems, tools, metrics and local requirements is essential
• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English
• The ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people
• Ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable
• Baccalaureate degree or equivalent experience with courses in public health, community program development, psychology/sociology, and research
• Valid driver’s license at time of hire
• Proficiency in Microsoft Word, Internet, Excel, and e-mail
• 2 years of research or data entry/registry experience
• Registration: Clinical Trials Management Certification
• Understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
• Experience in oncology
• Experience with Electronic Data Capture (InForm, Medidata Rave, etc.) systems
• Experience with medical terminology, tumor registries, or clinical research
• The SCRA conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes
• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members
• Appropriately reports and escalates serious or outstanding issues to project team member(s) and/or ACOM/COM/ Sr COM as appropriate, as defined in the study monitoring plan
• Facilitates Quality Assurance Audit processes as indicated. Ensures regulatory inspection readiness at assigned clinical sites
• Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines are met
• Prepares CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up
• Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators
• Participates in departmental and other functional meetings as needed, including Site Management & Monitoring meetings
• Identifies and partners with other AbbVie personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations while conserving overall departmental operating costs
• Maintains knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness and trends of industry practices and participation in professional activities
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations
• Good written and verbal communication skills. Written and verbal fluency in English and local language (if not English)
• Acute observational skills, analytical and conceptual capabilities
• Ability to work independently with minimal supervision
• 1) Implements assigned research studies by reviewing study and assessing institutional requirements
• 14) Maintains courteous and effective interactions with colleagues and patients
• 15) Demonstrates an understanding of the job description, performance expectations, and competency assessment
• 16) Demonstrates a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards
• 17) Participates in departmental and/or interdepartmental quality improvement activities
• 18) Participates in and successfully completes Mandatory Education
• 19) Performs all other duties as needed or directed to meet the needs of the department. Qualifications Education: Associates degree or equivalent work experience

Clinical Research Associate Cra-norway Resume Examples & Samples

• Willingness and ability to travel
• Excellent English/Norwegian skills
• Previous experience in the CRO industry would be advantageous
• Perform data entry, collection, and analytics to be utilized in programs across Hanger
• Assist with literature reviews with direction and supervision
• Assist in the preparation of both grant and IRB submissions with direction and supervision
• Maintain databases to be used by multiple teams
• Able to interface in person and electronically with both internal and external clinical, administrative and executive personnel
• Respond to project related communications proactively and timely
• Provide administrative and data support to clinical teams by assisting project teams in the completion of assigned project activities
• Attend project meetings as required
• Assist with travel arrangements
• Exhibit good written and verbal communication skills
• Critical thinking skills
• Demonstrate basic knowledge in mathematics, statistics and sciences
• Basic understanding of the orthotic and prosthetic profession
• Basic knowledge of MS Office suite programs
• Demonstrate high ethical standards regarding confidential patient information
• Typically requires less than 1 year of related experience
• If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally. Provide consistent best practice approach to onboarding, consolidating "lessons learned" across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner
• If assigned; With guidance, may serve as key point of contact in country/district for assigned study. Update Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments
• Site Monitoring Experience: Minimum 3 years
• BA/BS or higher in nursing, life or health sciences is preferred
• 5 years of pharmaceutical industry experience
• 4 years of experience in a CRA functional role
• Experience mentoring CRAs and CTAs is preferred
• Strong preference given to those with industry experience (pharma/biotech)
• Prepares and completes critical study documents and performs final editing/proofing prior to publishing (e.g. protocol; synopsis; flowchart; informed consent template; investigator brochure; monitoring guideline; statement of work laboratory, other vendors, and CROs; consultant agreements; investigative device/drug labels; clinical study worksheets; etc.)
• Monitors resources/reports to deliver milestones on time and budget
• Collect, reviews and files all clinical study documentation for assigned trial(s) and investigative sites and maintenance of clinical trial master file (CTMF): assures all documentation is maintained in compliance with all applicable guidelines and corresponding SOPs
• Participates, with the CTM, in the preparation and hosting of clinical study team meetings on an established schedule, providing agenda, recording/distributing of minutes and copying of minutes to CTM
• Works with the CTM to prepare and compile materials for clinical study conduct and reference information for study sites provided to the site in the form of an investigator site file (ISF)
• Prepares, collects and archives all study related correspondence to the investigator site including, but not limited to, newsletters, “Dear Dr.” letters, FDA/HA correspondence, contractual agreements and others
• Responsible for investigator recruitment and maintaining current contact information for each assigned investigator site, as well as preparing investigator site file for participation approval
• Collects pre-study documentation and essential regulatory documents from assigned investigator sites, as well as, collects updated documents prior to study initiation and on an ongoing basis
• Estimates, orders and coordinates shipments of clinical study supplies to assigned investigator sites
• Assists the CTM with tracking and requesting grant payments, and maintains study budget
• Tracks and reports all adverse events, protocol deviations, and any other unusual activity experienced by assigned investigator sites and communicates with assigned sites on routine matters
• Reviews all adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable
• Reports safety findings in a summary format to the CTM
• Prepares documentation for and attends Clinical Event Committee (CEC) meetings, if applicable
• Identifies and documents data errors or items requiring clarification on all documents collected for study and initiates data clarification/validation process after researching source documents
• Assists in preparing clinical reports of assigned projects for submission to regulatory authorities
• Bachelor’s Degree in life sciences of B.S.N. Nursing degree
• Experience in Phase I-IV clinical studies as a clinical trial assistant or clinical research associate is highly desirable
• Excellent Communication and writing skills, professionalism and ability to effectively interact with staff and management alike; ability to verbally communicate effectively with management, department clinical research and other team members
• Experience as a clinical research associate minimum of three years
• At least 2 years related experience in (conducting) clinical trials (healthcare setting, CRO, medical device and/or pharmaceutical company and/or industry)
• Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently
• Mentor team member by sharing tips/tricks/tools reviewing process prior to and after visit
• Assists management team by mentoring other CRAs
• Assists with preparation and/or delivery of presentations for UBC Academy, departmental training and/or sponsor specific training
• Ability to perform tasks in CTMS, EDC, Outlook and client specific systems (if applicable)
• Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to Clinical Site Specialist/Regulatory
• Document Specialist for filing in Trial Master File according to UBC and/or sponsor timelines requiring minimal corrections
• Ensures follow-up of site issues and action items per UBC/sponsor timelines
• Consistently completes SOP review and documentation within requested timelines
• Consistently completes sponsor specific training and documentation within requested timeline
• Assists PM and management team by being an Assess Instruct and Mentor leader
• Minimum of > 24 months active monitoring
• Ability to perform tasks in UBC’s Clinical Trial Management System, Electronic Data Capture System, Outlook and client specific systems (if applicable)
• Up to 80% travel

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