clinical research associate quizlet

20 Clinical Research Associate Interview Questions and Answers

Common Clinical Research Associate interview questions, how to answer them, and sample answers from a certified career coach.

Clinical research associates are essential to the success of any clinical trial. As a CRA, you’ll be responsible for managing the day-to-day operations of a study and ensuring that it adheres to all regulations.

But before you can start making sure trials run smoothly, you have to get through your job interview. To help you prepare for this important step in the hiring process, we’ve put together some common questions you might encounter during a clinical research associate interview. Read on—and ace your next job interview!

• What experience do you have with clinical trial design and protocol development?
• Describe a time when you had to manage multiple research projects simultaneously.
• How do you ensure that all data collected is accurate and compliant with regulations?
• Explain the concept of Good Clinical Practice (GCP) and how it applies to your role as a Clinical Research Associate.
• Are you familiar with the different types of clinical trials and their purpose?
• What strategies do you use to stay organized while managing multiple research sites?
• How do you handle difficult conversations with research participants or sponsors?
• Describe a situation in which you had to troubleshoot an issue with a research site.
• What are the most important considerations for ensuring patient safety during a clinical trial?
• Have you ever worked on a project where there were language barriers between yourself and the research participants? If so, what did you do to overcome them?
• What strategies do you use to ensure that research protocols are followed correctly at each research site?
• Describe your experience working with Institutional Review Boards (IRBs).
• What steps do you take to ensure that informed consent forms are properly completed by research participants?
• How do you handle conflicts between research staff and investigators?
• What methods do you use to monitor research progress and identify potential issues before they become serious problems?
• Do you have any experience with developing recruitment materials for clinical trials?
• How do you approach training new research staff members?
• What strategies do you use to maintain relationships with research sponsors?
• Describe a time when you had to present complex research results to a non-technical audience.
• What challenges have you faced while conducting remote clinical trials?

1. What experience do you have with clinical trial design and protocol development?

Clinical research associates, or CRAs, are responsible for managing clinical trials for pharmaceutical companies and other organizations. This means they need to be well-versed in clinical trial design and protocol development, as these are the two main tasks they will be responsible for. The interviewer is looking for candidates who have experience in these areas, so they can be sure the candidate is capable of handling the job.

How to Answer:

When answering this question, you should provide a detailed explanation of your experience with clinical trial design and protocol development. Talk about the types of trials you have designed or developed protocols for, as well as any special techniques or methods you used. You can also mention any challenges you faced during these processes and how you overcame them. Finally, be sure to emphasize any successes you’ve had in designing successful clinical trials or developing effective protocols.

Example: “I have extensive experience with clinical trial design and protocol development. I’ve designed dozens of trials for pharmaceutical companies, ranging from phase 1 to phase 3 studies. My work has included developing protocols for randomized controlled trials, observational studies, and crossover studies. I have a strong understanding of the principles of good clinical practice and am well-versed in FDA regulations and guidelines. Additionally, I’m familiar with various statistical methods used in clinical research and have developed data analysis plans for my studies. I take great pride in my ability to develop effective protocols that lead to successful clinical trials.”

2. Describe a time when you had to manage multiple research projects simultaneously.

Clinical research associates often have a lot of tasks to juggle, from recruiting and screening participants to organizing and maintaining data. This question helps the interviewer get an understanding of how well you can multitask and manage your workload, as well as how you handle the stress of working on multiple projects at the same time.

To answer this question, you should focus on any experience you have in clinical trial design and protocol development. Talk about how you’ve worked with a team to develop protocols for trials, what processes you used, and the results of those protocols. You can also discuss other tasks that you may have completed related to clinical research such as data analysis or report writing. Finally, be sure to mention any tools or software you have used to help manage your workload.

Example: “In my previous role as a clinical research associate, I was responsible for managing multiple research projects simultaneously. I worked with the team to develop protocols for trials and then monitored their progress. To help me manage all of the tasks associated with each project, I used software such as Microsoft Project and Excel to track timelines, budgets, and other key data points. In addition, I regularly communicated with the participants and stakeholders involved in the trial to ensure that everything stayed on schedule. As a result of my work, we were able to successfully complete all of our research projects on time and within budget.”

3. How do you ensure that all data collected is accurate and compliant with regulations?

Clinical research is a highly regulated field, and it’s important for a Clinical Research Associate to remain compliant with all applicable laws and regulations. By asking this question, the interviewer is trying to get a sense of how you will be able to ensure accuracy and compliance when collecting data. They want to know that you understand the importance of accuracy and compliance, and that you will take the necessary steps to ensure that data is collected in a way that meets all applicable regulations.

You should emphasize your understanding of the importance of accuracy and compliance when collecting data. Explain that you are familiar with all applicable regulations, and that you will take the necessary steps to ensure accuracy and compliance. These steps may include double-checking data entry for accuracy, or verifying data against source documents. You can also explain that you have experience using software tools designed to help maintain accuracy and compliance, such as electronic data capture systems or digital forms.

Example: “I understand the importance of accuracy and compliance when collecting data, and I always take the necessary steps to ensure that all data collected is accurate and compliant with regulations. To do this, I double-check all data entry for accuracy and verify it against source documents. I also have experience using software tools designed to help maintain accuracy and compliance, such as electronic data capture systems or digital forms.”

4. Explain the concept of Good Clinical Practice (GCP) and how it applies to your role as a Clinical Research Associate.

Clinical research associates (CRAs) are responsible for ensuring that clinical trials are conducted according to the highest ethical and scientific standards. GCP is a set of ethical and scientific quality standards for the design, conduct, monitoring, and reporting of clinical trials. By asking this question, the interviewer is looking to assess your knowledge and understanding of GCP and how it applies to your role.

Start by explaining what Good Clinical Practice is and why it’s important. You can mention that GCP provides an international ethical and scientific quality standard for the design, conduct, monitoring, recording, auditing, analysis, and reporting of clinical trials. Then explain how you ensure compliance with GCP as a CRA. Talk about your experience in developing protocols, reviewing case report forms, collecting data, and conducting site visits to ensure compliance with applicable standards. Finally, discuss any additional measures you take to ensure the highest ethical and scientific standards are met.

Example: “Good Clinical Practice (GCP) is a set of international ethical and scientific quality standards for the design, conduct, monitoring, recording, auditing, analysis, and reporting of clinical trials. As a Clinical Research Associate, it’s my responsibility to ensure that all studies I am involved in adhere to GCP guidelines. This includes developing protocols, reviewing case report forms, collecting data, and conducting site visits to ensure compliance with applicable standards. Additionally, I always make sure to document any deviations from GCP and take corrective action when needed. My experience has taught me that following these guidelines is essential for the success of clinical trials.”

5. Are you familiar with the different types of clinical trials and their purpose?

Clinical research associates are responsible for a variety of tasks, from designing and implementing clinical studies to monitoring and analyzing results. To make sure you have the necessary knowledge and experience to handle these tasks, interviewers want to know if you’re familiar with the different types of clinical trials and their purpose. Being able to answer this question can demonstrate that you understand the basics of clinical research and can help the company design, execute, and analyze clinical trials.

To answer this question, you should be familiar with the types of clinical trials and their purpose. Common types of clinical trials include observational studies, interventional trials, randomized controlled trials, and crossover trials. You should also understand the different phases of a clinical trial (Phase I-IV) and what each phase entails. Finally, explain why these trials are important for advancing medical research and helping to develop new treatments and therapies.

Example: “Yes, I am familiar with the different types of clinical trials and their purpose. Observational studies are used to collect data on a particular group or population in order to identify any correlations between variables. Interventional trials involve giving participants either a drug or placebo and measuring the outcome. Randomized controlled trials compare two or more treatments by randomly assigning participants to one of the groups. Crossover trials measure the effects of multiple interventions over time. Finally, Phase I-IV clinical trials are conducted to evaluate safety, efficacy, and dosage of new drugs or treatments. These trials are essential for advancing medical research and helping to develop new treatments and therapies.”

6. What strategies do you use to stay organized while managing multiple research sites?

Clinical research associates have a lot of responsibility, and they need to be able to stay organized while they’re managing multiple research sites. This question gives the interviewer an opportunity to understand what strategies you use to keep track of all your tasks and make sure they’re completed in a timely manner.

Talk about the strategies you use to stay organized while managing multiple research sites. This could include things like using a calendar or scheduling system, setting up reminders for yourself, breaking projects down into smaller tasks, and delegating when needed. You can also discuss how you prioritize tasks and make sure all your deadlines are met. Additionally, talk about any specific tools or techniques that you’ve used in the past that have been successful.

Example: “I use a combination of strategies to stay organized while managing multiple research sites. I always have a calendar or scheduling system set up, and I make sure to break down larger projects into smaller tasks that are easier to manage. Additionally, I prioritize my tasks based on urgency and importance, so I can focus on the most important ones first. To ensure that I don’t miss any deadlines, I also set reminders for myself ahead of time. Finally, when needed, I’ll delegate tasks to other members of the team in order to complete projects quickly and efficiently. All these strategies help me stay organized and on top of all my responsibilities.”

7. How do you handle difficult conversations with research participants or sponsors?

Clinical research associates are responsible for collecting and documenting data and keeping track of records. This requires a lot of interaction with research participants, sponsors and other stakeholders, which can often be difficult conversations. An interviewer will want to know that you are capable of handling these conversations in a professional and effective manner.

To answer this question, you should discuss your approach to difficult conversations. For example, you could talk about how you maintain an open and honest dialogue with research participants or sponsors, while still being respectful of their time and opinions. You can also share examples of how you have successfully dealt with challenging conversations in the past, such as providing solutions or alternatives that satisfied both parties. Additionally, emphasize any communication skills you possess that help you navigate these types of conversations, such as active listening or problem-solving.

Example: “I understand that difficult conversations can be a part of my role as a clinical research associate, and I always strive to handle them with respect and professionalism. For example, when working with research participants or sponsors, I make sure to maintain an open dialogue and listen actively to their concerns. I also try to provide solutions or alternatives that are agreeable to both parties, while still staying on track with the project objectives. My strong communication skills help me to navigate these conversations effectively, ensuring that all stakeholders feel heard and respected.”

8. Describe a situation in which you had to troubleshoot an issue with a research site.

Clinical research associates are expected to be able to handle any and all problems that arise during a clinical trial. They must be able to quickly identify and address issues, from simple paperwork errors to more complex data discrepancies. This question allows the interviewer to get a sense of how you might handle any potential problems that may arise in the course of a research project.

Start by explaining the issue you faced, and then explain how you identified it. Talk about any steps you took to troubleshoot the problem and the methods you used to find a solution. If possible, provide an example of how your efforts resulted in a successful outcome. Finally, discuss what you learned from the experience and how it will help you in future projects.

Example: “During a recent clinical trial, I noticed a discrepancy between the data collected from one of the research sites and the data from the rest of the sites. I quickly identified the issue and identified the source of the discrepancy. I worked with the research site to troubleshoot the problem, and we were able to resolve the issue without having to halt the trial. This experience taught me the importance of being proactive in identifying and addressing potential issues, and I now have a better understanding of how to effectively troubleshoot any problems that may arise in a research project.”

9. What are the most important considerations for ensuring patient safety during a clinical trial?

Patient safety is paramount in clinical research, so it’s important for potential employers to make sure you understand the importance of safeguarding the participants in any clinical trial. This question is a great chance for you to demonstrate your knowledge of the regulations and protocols that govern clinical research and how to ensure that the trial is conducted in a safe and ethical manner.

Start by talking about the importance of patient safety in clinical research and how you prioritize it in your work. You can then discuss any protocols or regulations that you are aware of, such as those outlined by the FDA or other governing bodies. Talk about specific steps that you take to ensure patient safety, such as monitoring for adverse events, reporting any incidents, and following up with participants throughout the trial. Finally, mention any experience you have had with handling patient safety issues.

Example: “Patient safety is always my top priority when I am conducting clinical research. I always ensure that I am familiar with the relevant regulations and protocols, such as those outlined by the FDA, that govern clinical trials. I also take a number of steps to ensure patient safety, such as monitoring for adverse events and responding quickly if any are reported. I report any incidents to the appropriate parties and follow up with participants throughout the trial to ensure that they are comfortable and informed. I have also had experience in the past dealing with patient safety issues and I understand the importance of addressing them quickly and thoroughly.”

10. Have you ever worked on a project where there were language barriers between yourself and the research participants? If so, what did you do to overcome them?

Clinical research associates often have to work with people from different cultures and backgrounds, and they need to be able to communicate effectively with them. This means working with people who may have limited English proficiency or who use language that is unfamiliar to the interviewer. By asking this question, the interviewer is looking to find out if the candidate has the skills necessary to work in a multicultural environment and to find creative solutions to language barriers.

This question is designed to assess your ability to work with people from different cultural backgrounds and language abilities. You should be prepared to explain how you have handled language barriers in the past, such as utilizing translators or other resources, learning some basic phrases of the language, or using visual aids to communicate. Be sure to emphasize any successes that you’ve had in overcoming these challenges. Additionally, if you don’t have direct experience with this, discuss how you would go about tackling a similar challenge in the future.

Example: “I have worked on several projects where language barriers have been present. In these cases, I have employed a variety of strategies to ensure that I am able to communicate effectively with research participants. For instance, I have used translators to bridge the language gap, learned some basic phrases of the language, and utilized visual aids to communicate important research information. I have also found that having a friendly and open attitude towards the research participants helps to make them feel more comfortable and willing to communicate. Overall, I am confident that I have the skills necessary to effectively overcome language barriers in order to achieve successful research outcomes.”

11. What strategies do you use to ensure that research protocols are followed correctly at each research site?

Clinical research associates are responsible for ensuring the research protocols are followed correctly and that the data collected is accurate and reliable. They must be able to develop and implement strategies to ensure research sites are following the protocols established by the study sponsor. This question allows the interviewer to understand how the candidate approaches this responsibility and assess their level of experience in this area.

To answer this question, you should explain the strategies you use to ensure that research protocols are followed correctly at each research site. This may include conducting regular on-site monitoring visits, providing training and support to study staff, developing standard operating procedures (SOPs) for each research site, and ensuring all data collected is accurate and complete. Additionally, you can discuss any additional strategies you have used in the past such as establishing a system of checks and balances or implementing quality assurance processes.

Example: “I use a variety of strategies to ensure that research protocols are followed correctly at each research site. This includes conducting regular on-site monitoring visits to ensure that all study staff are following the protocols and procedures established by the study sponsor. I also provide training and support to study staff to ensure that all data collected is accurate and complete. In addition, I have developed standard operating procedures (SOPs) for each research site and established a system of checks and balances to ensure that all protocols are followed correctly. I have also implemented quality assurance processes to ensure that all data collected is accurate and reliable.”

12. Describe your experience working with Institutional Review Boards (IRBs).

Clinical research associates must have a strong understanding of the regulations and ethical considerations that surround the medical research field. Working with IRBs is a critical part of ensuring that a research study is conducted in a safe, ethical, and legal manner. This question is designed to ensure you have the knowledge and experience necessary to understand and comply with the applicable regulations.

To answer this question, you should provide specific examples of how you have worked with IRBs in the past. Talk about any protocols or procedures that you have followed to ensure compliance with regulations and ethical considerations. You can also mention any experience you have had submitting applications for approval, as well as any feedback you have received from the IRB on a research study. Additionally, it is important to demonstrate your understanding of the importance of working with an IRB and why their role is so critical in medical research.

Example: “I have extensive experience working with Institutional Review Boards (IRBs). I have prepared and submitted applications for approval, as well as developed protocols and procedures to ensure compliance with regulations and ethical considerations. I have also interacted with IRBs to discuss any changes or modifications that need to be made to the study. I understand the importance of working with an IRB and the role they play in ensuring that a research study is conducted in a safe, ethical, and legal manner. I am confident that I have the knowledge and experience necessary to work with IRBs effectively.”

13. What steps do you take to ensure that informed consent forms are properly completed by research participants?

Clinical research associates are responsible for ensuring that research participants are properly informed and have given consent before taking part in any study. This is a critical part of the job, and the interviewer wants to know that you understand the importance of this and are capable of following the necessary steps to ensure compliance with the applicable regulations.

Start by outlining the general steps you take when obtaining informed consent from research participants. Explain that you clearly explain the study to the participant and review any relevant documents or materials with them, such as the protocol and the informed consent form. You should emphasize that you always ensure that the participant fully understands what they are agreeing to before they sign the form. Additionally, discuss any additional steps you take to ensure compliance, such as having a witness present during the consent process or providing additional resources for the participant to review after signing the form.

Example: “When obtaining informed consent from research participants, I make sure to clearly explain the study and all relevant documents and materials, such as the protocol and the informed consent form, to the participant. I also ensure that they understand what they are agreeing to before they sign the form. Additionally, I always have a witness present during the consent process and provide additional resources for the participant to review after signing the form. This helps to ensure that the participant has been fully informed and is comfortable with the study before agreeing to participate.”

14. How do you handle conflicts between research staff and investigators?

Clinical research associates are responsible for managing the research process from start to finish, which includes managing any conflicts that may arise between research staff and investigators. The interviewer wants to ensure that the candidate can handle these conflicts in a professional, effective manner, and that they have the necessary skills to do so. This includes the ability to listen to both sides of the issue and identify potential solutions that work for everyone.

Start by describing a situation in which you had to manage a conflict between research staff and investigators. Explain the steps that you took to resolve the issue, such as listening to both sides of the story, understanding each person’s perspective, and identifying potential solutions that worked for everyone involved. Be sure to emphasize your ability to remain calm and professional throughout the process. Additionally, mention any strategies or techniques that you use to prevent conflicts from arising in the first place, such as proactively communicating expectations and keeping all parties informed about progress.

Example: “When I encounter conflicts between research staff and investigators, I always try to remain calm and professional. My top priority is to listen to both sides of the issue and understand all perspectives. I then identify potential solutions that work for everyone, and I make sure that all parties are informed about the outcome. I also take proactive steps to prevent conflicts from arising in the first place, such as setting clear expectations and timelines at the outset of a project, and keeping all parties informed about progress throughout the process.”

15. What methods do you use to monitor research progress and identify potential issues before they become serious problems?

Clinical research associates are responsible for overseeing research projects from start to finish, and they must be able to identify potential issues before they become serious problems. This question is designed to help the interviewer understand how you plan, monitor, and evaluate research projects and how you handle unexpected issues that might arise.

You should explain the methods you use to monitor research progress, such as tracking timelines and milestones, reviewing data regularly, and communicating with key stakeholders. You should also discuss how you identify potential issues before they become serious problems, such as proactively addressing any deviations from protocol or analyzing data for trends that may indicate a problem. Finally, you should describe how you handle unexpected issues, such as by quickly assessing the situation and taking appropriate action.

Example: “I use a combination of methods to monitor research progress and identify potential issues. I track timelines and milestones closely to make sure that the research is progressing on schedule, and I review data regularly to ensure accuracy and integrity. I also communicate regularly with key stakeholders to ensure that everyone is on the same page and that any potential issues are addressed quickly. Furthermore, I proactively analyze data for trends that may indicate a potential problem, and I address any deviations from protocol immediately. When unexpected issues arise, I quickly assess the situation and take appropriate action to ensure that the research progresses smoothly and that any potential issues are addressed in a timely manner.”

16. Do you have any experience with developing recruitment materials for clinical trials?

Clinical research associates are responsible for the day-to-day management of clinical trials, including patient recruitment and enrollment. Developing recruitment materials is a key part of the job, and interviewers will want to know if you have the experience to do it effectively. This question also serves as a way to gauge your understanding of the clinical research process and your overall knowledge of the industry.

If you have experience developing recruitment materials, this is a great opportunity to discuss your successes and the strategies you used. Talk about how you developed creative and effective messaging that resonated with potential participants and drove high-quality enrollments. If you don’t have any direct experience in this area, talk about transferable skills from past roles such as copywriting or marketing, and explain why they make you a strong candidate for this role.

Example: “I have extensive experience developing recruitment materials for clinical trials. In my previous role as a clinical research associate, I was responsible for designing and executing a comprehensive recruitment strategy for a high-profile clinical trial. I designed a series of print and digital materials targeting potential participants, which resulted in a high-quality enrollment of more than 500 participants. My approach was creative and data-driven, and I was able to use insights from our research to craft effective messaging that resonated with our target audience. I also have experience in copywriting and marketing, which I believe makes me well-suited for this role.”

17. How do you approach training new research staff members?

Clinical research associates are responsible for training and managing staff, as well as providing guidance to ensure research is conducted according to protocol. This question allows an interviewer to gauge your ability to lead and mentor others, as well as the level of detail you provide when providing instruction.

When answering this question, it’s important to demonstrate your ability to lead and guide others. Talk about the steps you take when training new staff members, such as providing a detailed overview of the protocol and expectations, offering hands-on demonstrations, and giving feedback throughout the process. You should also discuss the importance of remaining patient and understanding during the training process, especially if the individual is unfamiliar with the research field. Lastly, be sure to mention any additional techniques or methods you use to ensure new research staff understand the protocols and procedures they are expected to follow.

Example: “When training new research staff members, I make sure to provide a comprehensive overview of the protocol and expectations, and then I walk them through each step of the process. I also make sure to provide hands-on demonstrations of the tasks they will be expected to complete, and I give them feedback throughout the process. I understand that some research staff are new to the field and may not have the same level of experience as others, so I always make sure to remain patient and understanding. Additionally, I make sure to provide additional resources and materials they can refer to as needed, so they can continue to learn and grow in their role.”

18. What strategies do you use to maintain relationships with research sponsors?

Clinical research is a collaborative process, and it’s important for research associates to develop strong relationships with the sponsors they’re working with. Interviewers want to know that you’re able to maintain these relationships and keep them in good standing. By asking this question, they’re looking for an understanding of how you approach communication with sponsors and build trust with them over time.

The best way to answer this question is by providing concrete examples of strategies you’ve used in the past. You can talk about how you keep sponsors updated on progress and timelines, provide clear communication around any changes or delays, and show appreciation for their support. Additionally, you should emphasize your ability to be proactive and anticipate potential needs or issues that could arise. By demonstrating a strong understanding of how to maintain relationships with research sponsors, you’ll demonstrate that you have the skills necessary to be successful in the role.

Example: “I believe that strong relationships are the foundation of successful clinical research. I strive to maintain positive relationships with sponsors by being organized, reliable, and proactive. I always keep sponsors updated on progress and timelines, and I make sure to be clear and transparent in my communication around any changes or delays. I also make sure to show my appreciation for their support. Additionally, I’m always looking for opportunities to anticipate potential needs or issues that could arise and proactively address them. I believe that my commitment to communication and relationship building has been an essential part of my success as a clinical research associate.”

19. Describe a time when you had to present complex research results to a non-technical audience.

Clinical research associates are often responsible for communicating complex research results to a variety of stakeholders, from scientists and physicians to government representatives and the public. It’s important to be able to effectively communicate the results of your research in an understandable and accessible way. This question helps determine if you have the ability to do that.

To answer this question, you should provide an example from your past experience of a time when you had to present complex research results to a non-technical audience. Talk about the challenges you faced in terms of understanding their level of knowledge and how you overcame them. Describe how you were able to explain the research results in a way that was easy for them to understand. Finally, discuss what you learned from the experience and how it has helped you with similar presentations since then.

Example: “I once had to present a complex study on cancer genetics to a group of local government representatives who weren’t experts in the field. I was nervous at first, because I knew they wouldn’t understand the technical details of the research. But I was able to break down the results into simple language and visuals that made it easier for them to comprehend. I also made sure to answer any questions they had in a way that was easy for them to understand. After the presentation, I received positive feedback from the representatives, and I felt confident that I had communicated the study results effectively. From this experience, I learned the importance of tailoring my message to the audience, and I now make sure to do this for all of my presentations.”

20. What challenges have you faced while conducting remote clinical trials?

Clinical research associates often work remotely, and this question is designed to assess your understanding of the challenges associated with that type of work. It’s important to be able to communicate effectively with colleagues and stakeholders, as well as to be able to troubleshoot any issues that may arise while working remotely. This question also assesses how well you handle the unique challenges of remote clinical trials.

Be prepared to discuss the challenges you’ve faced while working remotely, such as difficulty in communication and coordination with colleagues, or problems with data collection. Additionally, talk about how you have overcome these challenges, such as using video conferencing tools or other technology platforms to stay connected with colleagues. You can also mention any strategies you use to remain organized and efficient while conducting remote clinical trials.

Example: “I’ve had a lot of experience conducting remote clinical trials and I’m well aware of the challenges that come with it. One of the biggest challenges I’ve faced is staying organized and on track with data collection. To overcome this, I use project management software and task tracking tools to ensure that data is collected on time and accurately. I also communicate regularly with my colleagues via video conferencing and other online collaboration tools to ensure that everyone is on the same page. I’ve found that these strategies have been effective in helping me to stay organized and efficient when conducting remote clinical trials.”

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Clinical Research Associate: A Full Guide on Becoming A CRA

Clinical Research Associate

A complete guide on how to become a clinical research associate.

Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care.

As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree.

This is why a career as a CRA should be considered with clinical research coordinator training. We train over 500 students each month in clinical research coordinator training and clinical research associate training (depending on prior background).

For those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career.

Because the position is unlike actually working in the lab and more of a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.

Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered).

Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year: an amount that is uncommon in other science-degree careers.

CCRPS is one of the only major US-based ACCRE, ACCME, ANCC, ACPE, and Transcelerate Biopharma accredited CRA certification courses that accepts students with no prior background for certification. T

his is because our course is thorough and created by Senior CRAs who have been in the field for long enough to understand what you need to know to begin working and applying. The course can be completed in as little as 7 days with dedicated full-day study time.

Clinical Research Associate Certification Qualifications

Foreign Doctors Welcome : A Clinical Research Associate or Coordinator plays a vital role in directing and supervising clinical trials conducted by physicians, nurses, and other science professionals. This career path is particularly attractive to many foreign doctors with completed medical degrees (MBBS) who can utilize their expertise in the US healthcare system by pursuing a CRA career instead of taking the USMLE or repeating residency training. For those interested in coordinating aspects, consider the Clinical Research Coordinator course .

Distinct Skillset : Unlike the traditional medical field you may be familiar with after years of schooling, Clinical Research Associate training provides a distinct and valuable skillset. For comprehensive understanding of Good Clinical Practice, see the ICH-GCP course .

Most Extensive Online Course : Our program goes beyond basic introductions, offering a comprehensive curriculum with over 110 modules – the most extensive Clinical Research Associate course available online. This in-depth training ensures you're well-prepared to secure a coveted CRA position.

Superior Coursework : Securing a CRA role is a strategic career move compared to the limitations of many traditional medical positions. While generic courses abound, we've observed that graduates often struggle due to a lack of substantive content. Our Clinical Research Associate course addresses this gap by providing Senior Clinical Research Associate-level training through 110 intensive modules grounded in the latest scientific principles. For those looking to assist in clinical trials, the Clinical Trials Assistant Training may also be of interest.

Diverse Career Opportunities : This high-demand science-based medical field offers diverse opportunities:

Work in the Private Sector : Pursue a CRA career with renowned pharmaceutical companies like Pfizer. Enhance your skills with the Advanced Clinical Research Project Manager Certification .

Academic Opportunities : Work in the academic sphere at medical schools. Those aiming for higher responsibilities may consider the Advanced Principal Investigator Physician Certification .

Unmatched Flexibility and Knowledge : In addition to our exceptional course content, we boast the largest number of clinical research courses available online, providing you with unmatched flexibility and knowledge. For those interested in safety monitoring of drugs, the Pharmacovigilance Certification and Medical Monitor Certification can enhance your capabilities in these critical areas.

Why Take A CRA Certification Course

 The role of the clinical research associate is to ensure that medical devices, new treatments and new drugs are approved for patients' use.

This field is taken as a certificate program course in many schools. For example, you may find associate degree programs. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.

If you opt for a fully online program, you can still get an immersive education. Different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as the lecturers.

Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order for students to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.

These certificate programs are generally designed for professionals that are already in the medical fields (like medical assistants or nurses) and are interested in moving to the field of clinical research.

They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.

Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials.

During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.

The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective. The need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience in clinical trials.

Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.

In applying for the post of a clinical research associate , ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to.

Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might increase your chances.

Further certification can enhance your resume such as the ACCRE accredited CRA program which contains 110 learning modules for Clinical Research Associate Training and Placement

The Best CRA Certification Course For Entry-Levels

There is a huge shortage of well-trained CRAs, but many companies are reluctant to hire untrained entry-level clinical monitors because of patient and trial safety. Because of this, even the beginner entry-level jobs require certification or training.

Our program is considered one of the top clinical research graduate programs online. Most courses provide very light training that may look good because of the company names, but alone is not sufficient to pass the interview rounds a company conducts.

Because our modules are prepared help even Senior Clinical Research Associates, we find more of our students with no background quickly passing their interview rounds.

CCRPS Course covers double to triple the amount of course content than other courses. While many courses are simply 5-20 simple interactive modules, our course covers 140 dense modules in thorough detail.

After each session, students can ask their questions privately with the course instructor, all of whom have 15+ years of CRA experience.

Currently, 82% of our students are hired within the first month of taking the course. Students with limited background or those looking to gain extra experience are offered a remote internship of up to 6 months during the time they are interviewing.

This advantage allows many students with limited experience to get hired with a higher paying job than previously offered.

While a majority of our students are physicians, a majority of the CRA workforce are Science Grads and Nurses. nonetheless, we train all students at a Senior CRA level regardless of background because clinical research monitoring is vastly different from any lab or science course you may have taken.

Clinical research associates are given the protocol of a study including all medical protocol that must be followed but because they do not diagnose or treat. Medical knowledge is supplemental but not sufficient in this career path.

This is the main reason why our Clinical Research Training includes all possible scenarios you may face at the protocol and guideline level in your future company.

How To Get Experience For Clinical Research Associate Jobs

CCRPS, like other educational institutes, is only associated with educating and certifying clinical research professionals so we do not provide job placement. We want to make sure you apply with your best foot forward. Below are links we readily refer to graduates who are looking for job support. Having a great CV and cover letter are essential to applying for jobs. Recruiters are paid by the company which hires you and thus are free for searching employees. Be realistic but also be driven. Make sure you get continue reaching out until you get a true rejection from any job you apply to as they may never have seen your application if you received no response.

Clinical Research Job Advising: Kunal at ClinicalTrialPodcast

Free Resume Review: TopCV TopCV provides a free review and feedback for your current resume.

Resume Distribution: ResumeRabbit Resume rabbit distributes your resume to 60 job posting sites.

Clinical Research Recruiters: I-Recruit I-Recruit distributes your resume to clinical research recruiters.

Clinical Research Job Bulletin: Indeed Indeed usually provides the most uptodate job bulletin for clinical research jobs

Always use a cover letter specific for the company and job when applying if you are not using a recruiter.

The ICH-GCP in Clinical Research

Regardless of the type of clinical research or function of an IP being tested, it is important that clinical research should meet two critical criteria:

The clinical research process should respect the rights, freedom and dignity of tested patients (human participants).

Data from the clinical research process should be accurately collected, safely stored, rigorously scrutinized and correctly interpreted.

One way to ensure that these requirements are met is to follow a set of internationally recognized and accepted standards for clinical research. 

Most countries across the world today follow ICH-GCP, that is, International Committee for Harmonization of Good Clinical Practice guidelines in conducting clinical research on human participants7.

The ICH-GCP outlines procedures and precautions that are essential in order to protect the safety and wellbeing of human research participants during clinical research, and to ensure the integrity of data from clinical research studies.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.z

Qualifications and Qualities of a CRA

According to the International Accrediting Organization for Clinical Research (IAOCR), candidates for CRA positions usually hold either a biological science degree, or one in medicine or nursing10. 

The New Scientist recommends that aspiring CRAs should possess a good working knowledge of one or more of the following subjects – anatomy, biology, biochemistry, chemistry, immunology, microbiology, pharmacology, physiology or toxicology11.

In addition to a background in medical or life sciences, a CRA is required to have a good grasp of data management, including Electronic Data Capture (EDC), data analytics and reporting12.

Sketching the CRA work profile, the authors Diane St. Germain and Marjorie Good state that CRAs are the ones who scrutinize clinical study data most closely from start to finish—as a result, they are often the first to notice critical patterns and interesting trends, and to report these to the research team as well as to the CRO13.

Equally if not more importantly, a CRA must possess a high level of emotional and interpersonal savvy. This is a crucial area, since a CRA’s success hin ges upon his/her ability to elicit the best from team members, in terms of both performance and probity. 

Core Competency Framework for CRAs

To illustrate, the ACRP’s ‘Core Competency

Framework for Clinical Study Monitoring’

requires that a CRA should be able to identify

and correct compliance violations at a study

site. The CRA must not only bring such

violations to the attention of site staff, s/he

must induce them to take corrective action,

as well as reporting the matter and even

escalating it, where necessary14.

The table below summarizes the ideal

competencies of a CRA, and provides

insights on how each ability contributes to

the CRA’s performance.

CRA Career Path

In the past, CRA positions were often filled by individuals with medical or nursing backgrounds, with little thought given to their lack of research training15. As awareness grew about the importance of research experience for a CRA, employers began preferring those with years of experience in clinical research settings, such as Clinical Trials Assistants (CTAs) and Clinical Research Coordinators (CRCs)16.

However, in recent years, the focus has shifted once again from a tenure-based mindset to a skills-based evaluation17. In part, this change has been brought about by the growth in professional courses and training programs in the field. 

For instance, many leading US Universities today offer master’s programs in clinical research18. In addition, there are some widely recognized certification programs for clinical research associates, such as those offered by the ACRP19 and the Society of Clinical Research Associates (SOCRA) 20.

Note: You must already be working as a CRA to qualify for the ACRP and SOCRA certification programs.

A Toe in the Door: CRA Certification for a Non-CRA

By this point, you might be wondering, “I have no research experience… I’ve never worked as a Clinical Trials Assistant (CTA) or a s a Clinical Research Coordinator (CRC). Nor do I have a degree in Clinical Research. Can I still become a CRA?”

The simple answer is, yes, you can.

You might be a life sciences graduate looking for a lucrative career in the pharmaceutical or biotechnology sectors. Or, you’re excited by a career in research, but unsure whether the drudgery of a Ph.D. is your thing.

Maybe you’re just looking for a job that represents a great option for someone with your combo of science background plus detail-orientedness.

Whichever of these descriptions best applies to you, a career as a Clinical Research Associate could be exactly right for you.

With the right training, you can be recruited directly to a Clinical Research Associate position, even without a background in clinical research.

So, what kind of training will help me break through the ‘experience’ barrier and land a job as a CRA?

As you’ve already gathered from the table, the skill-set required to be a successful CRA is pretty extensive.

Aside from an in-depth knowledge of scientific and medical concepts and principles, a CRA must have a sound grasp of medical research regulatory requirements, a penchant for being thorough and systematic, as well as a knack for coordinating and managing people with diverse skills, roles and backgrounds.

To our knowledge, CCRPC’s ‘Advanced Clinical Research Associate Certification’ (ACRAC) is one of a kind: The ACRAC is the only multi-accredited* certification program in the US that offers the kind of exhaustive as well as intensive training that equips candidates from a non-clinical background with the abilities and competencies that make a good CRA.

Best of all? The ACRAC is open to fresh graduates holding a B.S. degree in any of the life sciences, with no requirement for prior exposure or experience in clinical research.

*The ACRAC program offered by CCRPC is accredited to ACCRE (Accreditation Council for Clinical Research & Education), ACCME (Accreditation Council for Continuing Medical Education), ACPE (Accreditation Council for Pharmacy Education), ANCC (A merican Nurses Credentialing Center), as well as Transcelerate Biopharma.

Training to be a CRA through CCRPS ACRAC

The ACRAC program includes over 100 course modules that cover all the important knowledge domains and skill-sets required by a CRA.

Designed for a total study time of approximately 250 hours, this training program can be completed at your own pace, or, for those able to dedicate the whole day to study, in as little as two to three weeks.

Starting with a broad overview of clinical research jargon and terminology, the course walks students through the principles of Good Clinical Practice, familiarizing you with the relevant sections of the ICH-GCP and the FDA’s E6(R2).

The program places particular emphasis on ethical practices in research with vulnerable populations.

Students going through the ACRAC are trained in all major aspects of designing a Clinical Trial Protocol in keeping with the Code of Federal Regulations (CFR).

They additionally learn the steps involved in the IRB/IEC approvals process and how to prepare required documents.

Finally, students become aware of the importance of pharmacovigilance and the regulatory process for new drug testing.

A major chunk of the ACRAC certification centers around equipping the CRA for day-to-day responsibilities, such as different types of site visits – preliminary (Site Qualification), preparatory (Site Initiation) and progress monitoring visits (Routine Monitoring).

Crucially, the ACRAC covers essential documentation such as the Case Report Form and Trial Master File, as well as electronic data capture (EDC) and remote monitoring systems.

A vital component of the training program involves empowering students to tackle challenging situations.

For a CRA, these include identifying protocol deviations and violations, and recognizing as well as reporting research fraud and ethical misconduct.

In addition to its comprehensive coverage, the ACRAC certification offers the great advantage of including 17.5 CME credits – that is, course credits that count towards ‘Continuing Medical Education’.

These credits can be used by individuals desiring to further their education and/or careers in healthcare-related fields, including medicine, nursing, pharmacy and research.

Clinical Research Associate Training

Get ahead in clinical research with advanced accredited online CRA certification for $450. Demo our on-demand course below.

Clinical Research Associate Certification

Advanced clinical research associate certification (acrac).

Chapter 1: Introduction

This chapter orients you to the concept of Continuing Medical Education (CME) and outlines how the CCRPS CRA program contents meets AMA requirements for CME. Given that, across the US, physician practitioners are required to complete between 20 and 50 hours of CME credits yearly, the ACCME-accredited CCRPS CRA course can be used not only to build knowledge and skills in the field of clinical trial management, but also to further a successful medical career. Additionally, the introductory chapter introduces you to the clinical terminology and abbreviations commonly encountered in clinical research, for example, Investigational Product (IP), Good Clinical Practice (GCP), Institutional Review Board (IRB) and so on. 

Chapter 2: Roles and Relationships in Clinical Trials

The unit presents the foundational background to beginning and building a career as a clinical research associate (CRA). As you know, a CRA plays a critical role in setting up as well as monitoring the clinical trials process for an investigational product or IP – a medical drug or device under development. In this unit, you will learn how a CRA interacts with other stakeholders, including the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC),other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

Chapter 3: Sponsor and Investigator Roles

In this unit, you will gain insight into the ICH-GCP guidelines, particularly addendum E6, sections 2 through 5, which outline procedures and precautions essential for protecting the safety and wellbeing of human research participants during clinical research. These include guidelines for obtaining informed consent from human subjects, maintenance of trial records, reporting of compliance, safety and research progress, as well as procedures for suspension or termination of the trials process. The chapter familiarizes you with the critical importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

Chapter 4: Clinical Trial Design

In this chapter, you will acquire insight into the different phases of the clinical trials process, from the pre-clinical phase through Phases 0 to 4 of clinical testing. The unit will familiarize you with important concepts of clinical trials, such as the structure and goals of each phase of clinical trials, approaches to dosing, toxicology of pharmaceutical products, in vitro and in vivo testing, dose escalation and so on. Finally, the chapter reviews the FDA’s drug approval process.

Chapter 5: ICH-GCP – Overview

The chapter dives deep into GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as  Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

Chapter 6: Ethical Research in Vulnerable Populations

The unit provides a detailed walk-through of the regulations and compliance requirements for conducting clinical trials with human subjects who meet the definition of a ‘vulnerable population’, including pregnant women and fetuses, children, mentally incapacitated individuals (those with cognitive functioning impaired by neurolopsychological conditions or chronic substance abuse), as well as prisoners. You will acquire familiarity with the challenges of research in such populations, including the requirement for parental consent, fair but not excessive incentive, justifiable deception or incomplete disclosure, coercive practices and so forth.

Chapter 7: Adverse Events

Through this module, you will gain a bird’s eye view of the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects. 

Chapter 8: Clinical Trial Protocol

The chapter provides an in-depth tutorial on the structure and elements of a CTP or clinical trial protocol, as well as guidelines on writing a CTP. Important concepts reviewed include study Risk Benefit Analysis (RBA), study sample statistics (sample size, statistical power, plan for data analysis), risk management and study administration. Additionally, the module covers concepts central to study sample selection, addressing inclusion and exclusion criteria, especially safety and ethics considerations in sampling. 

Chapter 9: Protocol Deviations and Violations

Through this unit, you will gain familiarity with the many potential causes of protocol deviations and violations, learning to distinguish between minor (deviations) and major departures or violations of protocol. Content provides understanding of the most commonly occurring violations, including both minor (off-schedule subject assessments, subjects’ use of prohibited drugs, and so on) as well as major violations (failure to obtain informed consent, failure to report AEs and so forth). Further, the chapter reviews principles for reporting protocol deviations, IRB approval for planned deviations and related concepts. 

Chapter 10: IRB and DSMB

This chapter briefly reviews the history of IRBs and examines the principles guiding IRB decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.   

Chapter 11: Review Questions

The module provides a self-assessment tool by including questions that review the content covered in previous chapters. The set of 71 questions examines all aspects of ICH-GCP previously discussed.

Chapter 12: Site Monitoring Visits

In this module, an overview is provided of the different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

Chapter 13: Site Qualification Visit (SQV)

The chapter gives an in-depth understanding of the stages and steps involved in selecting a study site. Elements reviewed within the module include the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). Importantly, the module reviews the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.  

Chapter 14: Site Initiation Visit (SIV)

The module dives into the details of an SIV or site initiation visit. You will review the procedure for pre-SIV preparation, including filing for IRB and other necessary approvals, permits and licenses. Additionally, the chapter examines elements of the SIV agenda, mainly orientation and training of site staff, creation of important study-related documents such as the Trial Master File (TMF) and post-SIV filing of compliance documents such as FDA form 1572 and Financial Disclosure Form (FDF) for relevant site personnel. 

Chapter 15: Routine Monitoring Visit (RMV)

In this unit, the elements of a routine or periodic monitoring visit are discussed in detail. You will become familiar with the agenda of an RMV, which prioritizes receiving updates on AEs from site staff (incidence, documentation, seriousness and so on), as well as oversight of the overall progress of trials. The chapter covers different approaches to site monitoring, contrasting traditional (full-scale) monitoring with risk-based monitoring (RBM), as well as comparing on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is central to obtaining meaningful, high-quality data from clinical trials.

Chapter 16: Site Close-Out Visit (SCOV)

The module gives you a comprehensive overview of the protocol and procedures involved in terminating or closing out a trial site. Aspects covered in the chapter include pre-SCOV preparations such as IRB notification and schedule coordination among site staff (PI, other investigators, medical staff) and monitoring team (CRC, CRAs and so on), agenda for an SCOV – drug inventory management, database verification and lockdown, subject intimation and completion of all subject-related documents, staff-related documentation as well as other administrative tasks including close-out report compilation.

Chapter 17: Tools for Monitoring Visits

This unit outlines a host of tips and tools that can help a CRA in successfully tackling the complex process of monitoring clinical trials. The chapter lists numerous physical accessories you can use for effective monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions. 

Chapter 18: Audit and Inspections

The module deals with one of the most crucial and often most feared aspects of a CRA’s career – audits and inspections by the CRO (sponsor), FDA or other regulatory authority. Starting from the basic distinction between an audit and an inspection, the chapter covers in detail the protocols for both audits and inspections. Crucially, the chapter will enable you to grasp the difference between a routine audit/ inspection and a ‘for-cause’ audit/ inspection. Further, it lays out the sequence of an FDA inspection in full (including a detailed walk-through of the FDA BIMO or Biomedical Research Monitoring Program inspection), and provides important guidelines on the do’s and dont’s for CRAs during an audit/ inspection, such as the critical ‘3 to 5 minute rule’. You will acquire familiarity with important audit and inspection-related documents such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation) as well as the Establishment Inspection Report (EIR) prepared by the auditor/ inspector. Finally, you will gain insight into the classes of observations provided in an EIR, including NAI (no action indicated), VAI (voluntary action indicated) and OAI (official action indicated)—the last is commonly termed an ‘FDA warning letter’.

Chapter 19: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of clinical trial quality monitoring, including monitoring visits, tools as well as audits and inspections.

Chapter 20: SDV and Informed Consent

In this chapter, the ICH-GCP section 4.8 guidelines on obtaining informed consent from subjects are discussed in detail, highlighting the need for using non-technical language, transparent delineation of risks, consent without undue influence, obtaining consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to conform to ICH-GCP requirements that subject trial data (as recorded in Case Report Forms or CRFs) must correspond to source data (previous medical records).

Chapter 21: Case Report Form

The module provides an in-depth tutorial on the structure and elements of a Case Report Form or CRF, including the different forms for PI verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events and so on. In addition, the chapter outlines important data notation rules, such as the use of accepted acronyms (‘ND’ for missing data and ‘UNK’ for unknown information, MM-DD-YY format, time-stamp data and so forth), as well as guidelines for the design of CRFs (such as consistency of notation, avoidance of data fields that can be computed and of duplicate data fields and so on).

Chapter 22: Quality Control and Safety

Within this unit, you will learn the central concepts of Quality Control (QC) in the context of clinical trials, including definitions of QC and its relationship with the complementary process of Quality Assurance (QA), the use of Key Performance Indicators (KPIs) in QC, need for a Corrective and Preventive Action (CAPA) plan and so on. Additionally, the module examines the QA process, focusing on the central role of RBM or risk-based monitoring in present-day QA as well as providing guidelines on Quality Metrics (QMs) for evaluating the trials process. The chapter also reviews ICH-GCP guidelines on subject safety, underlining risk-benefit assessment, stoppage rules (for instance, in case of SAEs) and reporting responsibilities. Finally, it introduces the FDA’s Human Research Protection Program (HRPP) as a platform that provides training and support for personnel involved in clinical trials.

Chapter 23: Technology in Trials

In this chapter, an in-depth tutorial is provided of the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs) including IVRS and IWRS (Interactive Voice and Web Response Systems, respectively) as well as RTSM systems for Randomization and Trial Supply Management are examined.  The unit reviews the benefits of standardized data management and data sharing, approaches to database management and the concept of an Independent Data Monitoring Committee (IDMC). Critical elements of data integrity, such as proper anonymisation and coding, completeness of data, data safety precautions and logging of site visits and other progress reports are highlighted. The unit further examines the essential features of a good Clinical Data Management (CDM) system that complies with FDA CFR Title 21 and HIPAA regulations, such as setting access privileges, tracking changes and updates, data security and locking, flagging and reconciliation of AEs and so forth. Finally, the chapter looks at CTMSs (Clinical Trial Management Systems) in depth, covering the aspects that allow management of day-to-day trials in multi-site studies. 

Chapter 24: Modernized Monitoring (Remote, Risk-based, Centralized)

 This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements. Finally, the unit examines how risk-based monitoring approaches have allowed centralized monitoring to evolve into a cost-effective and safe method for clinical trial monitoring.

Chapter 25: Pharmacovigilance and Regulatory Affairs

Through this unit, you will gain insight into the process and rationale behind pharmacovigilance (PV) and its central role in the clinical trials process. The chapter reviews the statistics on AEs, distinguishes between Type A and Type B AEs, and profiles seriousness of ADRs or Adverse Drug Reactions as well as the iGuard Drug Risk Rating System. Importantly, the unit covers ADR causality assessment in detail, including both severity and probability assessment. An important element of PV addressed in this module is the Individual Case Safety Report (ICSR), its structure, content and role in trial monitoring. Other concepts discussed include types of PV inspections (routine vs. ‘for cause’), PSURs or Periodic Safety Update Reports and study criteria for instituting DSMBs (Data Safety Management Boards). Finally, the module also reviews the domain of Regulatory Affairs (RA) as a function of PV, outlining roles and responsibilities of RA personnel as well as the importance of RA in streamlining the process of drug development by ensuring compliance throughout manufacturing, clinical trials, marketing and advertising.

Chapter 26: Investigational Product

In this chapter, an in-depth review is provided of the protocol for receiving, storing and dispensing the IP or investigational product. At every stage, guidelines lay down strategies for ensuring verifiability, accountability and safety of both study subjects and staff. Thus, IP handling precautions include the need for logging date of manufacture, temperature throughout transit, as well as batch number and individual unit numbers (such as bottle or tube identifiers) carefully and accurately, as well as recording shipping details and filing shipping receipts. Additionally, the unit addresses the need for IP dispensing precautions, such as limiting dispensation to authorized personnel only, as well as maintaining individual subject IP logs.

Chapter 27: Local and Central Labs

The module profiles the evolution of lab testing in clinical trials, from error-prone localized laboratory testing to centralized testing that allows homogeneity of testing procedures and measurements, thus minimizing errors and improving outcomes. The chapter reviews standards for clinical trial laboratories as per the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments), as well as providing guidelines for lab audits, including fire safety, protective gear, staff training and so forth.

Chapter 28: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of trial documentation (SDV, CRF, ICSR), quality control, pharmacovigilance, as well as IP and lab guidelines.

Chapter 29: Regulatory Documents in Clinical Trials

The chapter reviews essential documentation to be created and maintained throughout the course of the clinical trials, including the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312, besides ethics approval documents such as the IRB-approved protocol, informed consent form, subject education and study advertising materials. You will acquire in-depth familiarity with each of these forms, and learn the importance of maintaining and updating records, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. In addition, the unit summarizes the need for filing documents outlining study- and site-specific procedures, including SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

Chapter 30: CFR Title 21 Part 11 – Electronic Signatures

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR), including Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56) and so on, Series on food (100), pharmaceuticals (200 and 300) and so on, as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES), laying down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

Chapter 31: New Drug Application

Through this module, you will gain knowledge of the FDA process for evaluating a drug under development, and the role of a CRA in streamlining this process. An important distinction covered here is the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The chapter discusses in-depth the criteria used in evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, the unit covers FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators. 

Chapter 32: Trial Master File

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF. 

Chapter 33: Disclosures and Payments for PI, Site, Patients

In this chapter, FDA guidelines regulating financial disclosure are discussed in-depth, covering the definition of ‘conflict of interest’ and the stipulations of Title 21 Section 54 on disclosure requirements. The unit helpfully contrasts FDA requirements with Canadian and UK/EU policies. You will study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on ‘fair market value’ as well as the Federal ‘Anti-Kickback Statute’. The unit contains guidelines on clinical trial budgeting and subject payments. Finally, the chapter reviews IRB guidelines on advertising to recruit human participants for clinical trials, including stipulations against misleading and coercive language, as well as excessive incentives.

Chapter 34: Patient Recruitment, Retention and Compliance

The unit provides an overview of the process of patient (subject) recruitment in clinical trials, from population research to identify motives for participation, to media support for building up public awareness and interest, to community and physician outreach for referrals and enrollment. Additionally, the chapter identifies common barriers to meeting recruitment goals and outlines strategies for maximizing recruitment, such as relaxing overly stringent criteria, offering reasonable incentives such as travel reimbursement and highlighting benefits of participation. Similarly, the unit covers common causes of patient drop-out as well as strategies for minimizing drop-outs, such as improving patient experience (increased attention and listening to patients, flexible scheduling of visits to suit patients’ convenience and so on). Finally, the unit discusses novel strategies to increase patient retention and improve compliance in clinical trials; these techniques harness technology to yield better outcomes, for example, simplifying form completion through digitized forms with auto-fill features, gamifying elements of compliance reporting, and so forth.

Chapter 35: Misconduct and Fraud

This module discusses the various motives for committing scientific fraud and the fallout of fraudulent practices in clinical trials. A scale for classifying errors in clinical trial data is presented, with ‘honest, isolated mistake’ at one end of the spectrum and ‘deliberate data falsification with malicious intent’ at the other. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will gain familiarity with the signs to watch out for during the actual clinical trials process. 

Chapter 36: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, including questions on all aspects of regulatory documents, site documents (TMF and contents), trial budgeting and payments, patient recruitment and scientific fraud.

Chapter 37: Site Visit Templates 

This module contains a set of templates that you can use for documenting the details of site monitoring as a CRA, either in their current form, or in a form adapted to the needs of your own study. The templates included in this unit include:

Site Qualification Visit (SQV) – checklist for preparations, questionnaire for assessing the site prior to the actual visit, assessment form and follow-up letter

Site Initiation Visit (SIV) – agenda for visit, confirmation letter to request PI attendance during SIV, report following SIV

Routine Monitoring Visit (RMV) – confirmation letter to request PI attendance, report following RMV, follow-up letter

Site Close-Out Visit (SCOV)  – confirmation letter to request PI attendance, agenda for SCOV, report following SCOV, follow-up letter

CRA transition letter  – document notifying site PI of appointment of new monitor (yourself as CRA) 

Chapter 38: Interviewing and Career

In this unit, you will find suggestions and recommendations for making a positive impact in interviews for CRA positions, as well as tips and strategies for making rapid progress in a clinical research career.

Chapter 39: Final Examination

This module comprises a comprehensive 51-item, self-paced quiz to assess your competency in the skills and knowledge required for a Clinical Research Associate position. 

https://www.beroeinc.com/category-intelligence/clinical-research-organizations-market/

https://www.linkedin.com/jobs/search?keywords=Clinical%20Research%20Associate&location=United%20States&geoId=103644278&trk=public_jobs_jobs-search-bar_search-submit&position=1&pageNum=0

https://www.centerwatch.com/articles/24791-demand-for-experienced-clinical-trial-professionals-outpacing-supply-acrp-says

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3317309/

https://www.niaid.nih.gov/research/dmid-investigational-product

https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860

https://www.fda.gov/files/drugs/published/E6%28R2%29-Good-Clinical-Practice--Integrated-Addendum-to-ICH-E6%28R1%29.pdf

https://www.who.int/groups/research-ethics-review-committee/recommended-format-for-a-research-protocol/

https://iaocr.com/finding-first-clinical-research-job/

https://jobs.newscientist.com/en-au/article/a-career-in-clinical-research/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/

St. Germain DC, Good MJ. 2017. Data management in clinical trials. In: Gallin JI, Ognibene FP, Lee Johnson L, editors. Principles and practice of clinical research. San Diego: Academic Press. p. 531-545. ISBN 978-0-12-849905-4

https://acrpnet.org/wp-content/uploads/dlm_uploads/2017/04/clinical-study-monitoring-competencies.pdf

https://www.clinicalleader.com/doc/starting-a-career-in-clinical-research-things-we-wish-we-knew-0001

https://www.proclinical.com/blogs/2021-9/how-to-get-a-job-as-a-clinical-research-associate-cra

https://acrpnet.org/2018/06/11/5-clinical-research-trends-emerge-at-acrp-2018/

https://www.collegechoice.net/sciences/clinical-research/best-masters-degrees/

https://acrpnet.org/certifications/cra-certification/

https://www.socra.org/certification/program-overview/

Pharmacovigilance: A Complete Guide to Pharmacovigilance and Drug Safety Training

The ultimate guide to clinical research monitoring.

Career Progression in Clinical Research: Transitioning from a Clinical Research Coordinator to a Monitoring Clinical Research Associate (CRA)

Thomas Boothby, MS, CCRP CRA II, Boston Scientific

Abstract : Research coordinators may transition to clinical research associates/monitors during their careers. This article provides an overview of how to determine whether it is the right time to make this transition, how to evaluate current competencies and gaps that must be filled in order to make this transition, and how to address needs during the on-boarding process. A roadmap in the form of a checklist is provided to help make the transition from research coordinator to clinical research associate (CRA) a smooth one.

Disclosure: The author has a relevant financial relationship with respect to this article with Boston Scientific, where he is employed as a monitoring CRA.

Introduction

A research coordinator is a person at the clinical research site who is involved in the daily tasks of enrollment, data entry, and all other aspects of clinical trials at the site level. A clinical research associate (CRA), or monitor, is the individual who visits clinical research sites to review their medical records and do the standard monitoring visits. Before the author was a CRA, he was a research coordinator for fourteen years. This article describes how the author made the transition from clinical research coordinator to CRA/clinical research monitor and includes some suggestions for those looking to make a similar career change.

When to Transition from Research Coordinator to CRA

While people naturally want to progress their careers as fast as possible, it is important to only make thetransition from research coordinator to CRA when the time is right. The grass is not always greener on the other side of the work fence.

The author knew that he was ready to make the transition from research coordinator to CRA because he felt that he had mastered all the tasks of a research coordinator. His job became stagnant, and he was looking for something better. Fatigue in the current work environment is another reason for why individuals may be looking to make this transition. Of all members of the clinical research team, research coordinators have the most difficult job. In the author’s opinion, they are often overworked and underpaid, and their contributions to the overall study are sometimes overlooked. Other reasons to make the transition from research coordinator to CRA include potential career progression and the opportunity to try something new. Some individuals may find that the travel component that goes along with being a monitor is a positive as well.

There are five stages of change according to a behavioral change model: pre-contemplation, contemplation, determination, action, and maintenance. In the pre-contemplation phase, people are not thinking about transitioning yet or may have obstacles in their daily lives that are preventing them from exploring new opportunities. When people are becoming serious about change, they are in the determination or action phases. During these phases, research coordinators who want to transition to CRAs might apply for new positions or become certified clinical research professionals (SOCRA CCRP®) as they try to gain new skills for the job market. When considering a transition from research coordinator to CRA, it is important to identify one’s place in the behavioral change model.

Qualifications and Background of CRAs

When the author was applying for CRA positions in 2015, he always saw a requirement for at least two years of experience as a monitor. This requirement is often a barrier to those looking to make this career transition. In 2010, ClinicalTrials.gov listed more than 100,000 clinical studies. By 2019, that number has increased to more than 300,000 clinical studies. The clinical research market has exploded over the last decade. More people are needed to monitor and to run clinical studies now than ever before. While some companies are less likely to require two years of monitoring experience now due to a depleted pool of candidates, these same companies may be more open to supplemental forms of experience such as certifications, course work, and on-the-job experience.

Thus, this is a great time to act on the decision to transition from research coordinator to CRA. From 2014 to 2024, the United States Bureau of Labor Statistics estimates that CRA positions will increase 14% annually. This increase in the job market, coupled with the high level of CRA turnover, could lead to a very strong job market in the future. At Boston Scientific, turnover among CRAs is fairly low due to the strong structure and principles. Many CRAs within Boston Scientific have been with the company for 10 to 20 years or longer.

Table 1 highlights the typical background of CRAs. Most CRAs are current or former nurses who have experience as a research coordinator or a research assistant. Many universities now offer bachelor’s, master’s, and certificate programs in clinical research as another form of training for these research related roles. In Michigan, where the author is from, Eastern Michigan University has a two-year master’s degree program in clinical research. Like the author, CRAs can often be a former research coordinator.

When the author was transitioning from research coordinator to CRA, he got his foot in the door by working closely with a monitor who still works for Boston Scientific. Relationships between research coordinators and CRAs can be contentious due to the nature of monitoring. Research coordinators should treat monitors and sponsor staff well and with respect, and they should treat monitoring visits as a learning opportunity and not a criticism of the coordinator’s work. These relationships do not need to be contentious. A good working relationship with a clinical research site’s CRAs can serve as a potential audition for a monitoring position.

CRAs typically have a clinical research certification, either SOCRA’s certified clinical research professional (CCRP®) or the Association of Clinical Research Professionals-Certified Professional (ACRP-CP). Some companies provide tuition reimbursement for programs and certifications such as these as a way of employee enhancement. Research coordinators can participate in enrichment programs such as these and obtain certifications to help boost their resume and become more marketable to CROs and sponsors. When researching these programs, individuals must do their due diligence to ensure that the program or certification is offered by a legitimate organization and is accredited. Hiring managers know where to find the gold standards in clinical research programs and certifications, and those that do not fit this standard can even be viewed as a negative on ones resume.

The author is a SOCRA CCRP®, Certified Clinical Research Professional, which is an excellent indicator of knowledge for a monitoring position. The test includes knowledge of the regulations and the role of the monitor. There are also some CRO-development programs such as SOCRA’s Clinical Research Monitoring Conference and one-year certificate programs such as the Harvard Medical School global clinical scholar’s research training program.

Networking through the clinical research site’s CRAs and professional forums and groups such as SOCRA is a great way to find CRA positions and interact with other research professionals. At conferences, CROs often have booths in the exhibit hall where research coordinators can meet CRO staff, learn more about opportunities, and leave their resume with CRO staff.

A Typical Day in the Life of a CRA

The life of a CRA has its positives and negatives (Table 2). There are many things that the author wishes he knew before he became a monitor. The author works from home a great deal of the time. If he is not on the road visiting a clinical research site, he is working at home either preparing for a visit, writing follow-up visit letters, or performing other administrative work. Visit preparation and follow up is a crucial part of the home office work. CRAs have very strict compliance guidelines for completing monitoring visits and monitoring reports in a timely manner. Since recently becoming a lead CRA, the author has also been doing a great deal of administrative and compliance work with more of a global view of a clinical trial.

Some clinical research organizations (CROs) and sponsors have onsite monitors who can do remote visits and activities. Whether visits are onsite or remote, monitors are constantly in contact with clinical research sites to follow up on action items from monitoring visits or to answer protocol specific questions the site coordinators may have.

At most companies, about 60-80% of the monitor’s time is spent traveling to sites. The author currently covers all of Michigan, and he has covered other areas, including Wisconsin, New York, Pennsylvania, and Ohio. CRAs are often away for several days at a time depending on the current workload. This can be difficult on families and personal relationships. While the author travels extensively, there are some times when he travels more than others. Sometimes he does back-to-back visits and may be gone for several days at a time. After that, he may be home for several days. The extensive travel required of CRAs is a key consideration when exploring this career transition.

Being a CRA takes a great deal of self-discipline. Monitoring offers a flexible work arrangement, so monitors can work later in the day or take time off during the normal workday. However, if the CRA does not accomplish what he/she should accomplish, this will be glaringly obvious. Management and co-workers will immediately know if the CRA does not show up to meetings or has difficulty answering questions about his/her monitoring activities or their monitor role in general.

Starting a Monitoring Job

Boston Scientific has a rigorous onboarding process comprised of four to six months of training. After the author was hired as a CRA, he spent months learning the work instructions and going out on preceptor visits. In the beginning, the new CRA observes a senior CRA. Over time, the new CRA does more of the monitoring. By the end of the training, the new CRA is doing the monitoring visit, and the senior CRA is observing and making suggestions to the new hire on how the new hire can improve.

There are various levels of monitors at Boston Scientific: CRA I (for new hires), CRA II, and senior CRA. More experienced CRAs often mentor new CRAs. It is extremely helpful to find CRAs who can serve as mentors and answer questions.

CROs and sponsors have many systems that CRAs must learn. At Boston Scientific, these systems include             electronic data capture, clinical trial management, auxiliary programs to help remote employees, and cloud-based filing systems. Being a CRA might be very difficult for people who are resistant to change or have difficulty with technology.

There are several types of monitoring (Table 3). The author would be considered a traditional CRA or monitor. By this, he does traditional onsite monitoring via annual or semi-annual visits to clinical research sites based upon the study’s monitoring plan. At smaller organizations, monitors may travel more often or may have an expanded territory to cover. It is important to ask how much travel is involved and how many monitors are on the team during the interview process. If a company has fewer monitors, more travel will be involved.

Many Boston Scientific protocols require annual monitoring visits. The author visits his clinical research sites at minimum once a year but generally 2-3 times per year. Some of the more difficult sites, high enrollers, and those that are more likely to be inspected by the U.S. Food and Drug Administration are monitored more often. Many sites are participating in more than one Boston Scientific study. For example, the author monitors a site in New York that is conducting several studies. He will monitor two studies during one visit. This saves him time and travel and saves the company money by reducing travel costs. Boston Scientific also uses a risk-based monitoring strategy.

In-house regulatory CRAs at Boston Scientific, called trial management CRAs, interact with the sites on regulatory matters, study startup, and study closure. They work primarily by email and lean on traditional CRAs such as the monitor to be the face of the company with the research coordinators and help ensure that tasks are completed on time. Many hospitals also run their own clinical studies and may have in-house monitors.

Boston Scientific does use remote monitoring in certain studies and circumstances. Remote monitoring takes a great deal of work and technological experience at both the sponsor and site level. It involves a great deal of scanning and correspondence by the research coordinators, which can take a lot of their time and resources.

Sponsor CRAs generally deal with one indication, while CRO CRAs can work on studies for different indications or therapies. In one month, for example, CRO CRAs may be doing four indications at four sites for four sponsors. This requires understanding a great deal of information and being able to use different systems. Good organization is key when working as a CRA, whether for a sponsor or a CRO.

Recently, the author progressed from a CRA II to a senior CRA. As a senior CRA, the author has a larger leadership role and is expected to participate more in training and mentoring other CRAs. Boston Scientific has some centralized monitoring that will look at certain metrics and internal documents to guide monitors in their daily monitoring activities. Monitors are closely linked to the trial managers who actually run the studies. They also deal with safety and data managers as well as their CRA manager and the director of operations. Boston Scientific recently created an associate clinical trial manager position as a way to slowly transition some staff members into clinical trial managers, and the author is also transitioning into this role. 

One common drawback about this transition process from research coordinator to CRA is that a CRA is one step removed from patient care. Working directly with patients as a research coordinator is something that the author misses. It is important to remember that CRAs help protect patients who are participating in clinical studies at more of an indirect level. This ideology helps prevent burnout, especially when monitors are swamped with the many reports that are necessary as part of the monitoring process.

Checklist for Transitioning from Research Coordinator to CRA

Table 4 has a checklist for determining whether one is ready to make the transition from research coordinator to CRA. Prior to applying for positions, the research coordinator must consider his/her stage in the behavior change model. Unless the research coordinator is ready to transition to a CRA position, he/she should not do it. Becoming a CRA can be difficult without two to five years of research experience in medical devices, pharma, or academia in some capacity. A research coordinator who wants to transition to a CRA should work closely with current CRAs who can provide mentoring and networking opportunities as well as exploring other networking avenues such as SOCRA and ACRP forums, LinkedIn, and also attending the annual events or local events put on by these organizations.

It is important for research coordinators to bolster their resumes by completing supplemental training or certifications. Resumes should be up-to-date and attractive to potential employers. This means including details about accomplishments along with basic information such as job titles and education.

The research coordinator must also consider the travel demands of a CRA position, the types of monitoring to pursue, and his/her stage in the behavior change model. Travel is a major part of a CRA position and should be a focal point of your conversation with a hiring representative. Finally, the types of monitoring including central monitoring, remote monitoring, and regional monitoring should be considered.  

Monitoring is a great job. It allows a lot of freedom. However, CRAs also have a great deal of responsibility. CRAs must be driven, willing to put in the time, and have the necessary work ethic while maintaining vigilance and holding others accountable for good clinical practices.

Typical Background of a CRA

• Nursing degree with a clinical research background
• Bachelor’s or master’s degree in clinical research
• Former/current research coordinator
• Clinical experience (medical assistant, registered nurse, or nurse practitioner)
• Clinical research certified ( SOCRA CCRP ® or ACRP-CP)
• Research experience/background
• Science/academic research background

The Life of a CRA

• This requires being self-motivated and driven
• Sometimes performing a combination of onsite and remote monitoring
• Email, etc.
• At times, CRAs are gone for several days at a time depending on current workload
• Visit preparation and follow-up is a crucial part of work at home

Types of Monitoring

• Annual or semi-annual visits based upon the monitoring plan
• Risk-based monitoring/central monitoring
• Remote monitoring
• In-house CRAs and regulatory CRAs
• Sponsor CRA/monitor
• CRO CRA/monitor 

Checklist for Transitioning from a Clinical Research Coordinator

to a Monitoring CRA (Clinical Research Associate)

• 2-5 years of research experience as a research coordinator or research assistant
• Able to work with current CRAs as part of a mentorship or network with CRAs
• Completion of supplemental training or certifications to support career goals and bolster resume
• Explore networking avenues
• Up-to-date resume that is attractive to potential employers
• Able to meet travel demands of a CRA position
• Consideration of types of monitoring to pursue
• Stage in the behavior change model

7 thoughts on “Career Progression in Clinical Research: Transitioning from a Clinical Research Coordinator to a Monitoring Clinical Research Associate (CRA)”

Your articles are always helpful and I always get something new to learn from them.

Research Update Organization

you are always giving something new. thank you for that.

Very clear and helpful article! The tables listing the different types of monitoring roles and the items to consider whether this is right transition are a great summary, too.

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This is a very clear and collective article. The tables are the best helpful tips and resources for anyone interested for career advancement in clinical research. I really appreciate the author’s time and effort to sharing this article.

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Clinical Researcher

Navigating a Career as a Clinical Research Professional: Where to Begin?

Clinical Researcher June 9, 2020

Clinical Researcher—June 2020 (Volume 34, Issue 6)

PEER REVIEWED

Bridget Kesling, MACPR; Carolynn Jones, DNP, MSPH, RN, FAAN; Jessica Fritter, MACPR; Marjorie V. Neidecker, PhD, MEng, RN, CCRP

Those seeking an initial career in clinical research often ask how they can “get a start” in the field. Some clinical research professionals may not have heard about clinical research careers until they landed that first job. Individuals sometimes report that they have entered the field “accidentally” and were not previously prepared. Those trying to enter the clinical research field lament that it is hard to “get your foot in the door,” even for entry-level jobs and even if you have clinical research education. An understanding of how individuals enter the field can be beneficial to newcomers who are targeting clinical research as a future career path, including those novices who are in an academic program for clinical research professionals.

We designed a survey to solicit information from students and alumni of an online academic clinical research graduate program offered by a large public university. The purpose of the survey was to gain information about how individuals have entered the field of clinical research; to identify facilitators and barriers of entering the field, including advice from seasoned practitioners; and to share the collected data with individuals who wanted to better understand employment prospects in clinical research.

Core competencies established and adopted for clinical research professionals in recent years have informed their training and education curricula and serve as a basis for evaluating and progressing in the major roles associated with the clinical research enterprise.{1,2} Further, entire academic programs have emerged to provide degree options for clinical research,{3,4} and academic research sites are focusing on standardized job descriptions.

For instance, Duke University re-structured its multiple clinical research job descriptions to streamline job titles and progression pathways using a competency-based, tiered approach. This led to advancement pathways and impacted institutional turnover rates in relevant research-related positions.{5,6} Other large clinical research sites or contract research organizations (CROs) have structured their onboarding and training according to clinical research core competencies. Indeed, major professional organizations and U.S. National Institutes of Health initiatives have adopted the Joint Task Force for Clinical Trial Competency as the gold standard approach to organizing training and certification.{7,8}

Recent research has revealed that academic medical centers, which employ a large number of clinical research professionals, are suffering from high staff turnover rates in this arena, with issues such as uncertainty of the job, dissatisfaction with training, and unclear professional development and role progression pathways being reported as culprits in this turnover.{9} Further, CROs report a significant shortage of clinical research associate (CRA) personnel.{10} Therefore, addressing factors that would help novices gain initial jobs would address an important workforce gap.

This mixed-methods survey study was initiated by a student of a clinical research graduate program at a large Midwest university who wanted to know how to find her first job in clinical research. Current students and alumni of the graduate program were invited to participate in an internet-based survey in the fall semester of 2018 via e-mails sent through the program listservs of current and graduated students from the program’s lead faculty. After the initial e-mail, two reminders were sent to prospective participants.

The survey specifically targeted students or alumni who had worked in clinical research. We purposefully avoided those students with no previous clinical research work experience, since they would not be able to discuss their pathway into the field. We collected basic demographic information, student’s enrollment status, information about their first clinical research position (including how it was attained), and narrative information to describe their professional progression in clinical research. Additional information was solicited about professional organization membership and certification, and about the impact of graduate education on the acquisition of clinical research jobs and/or role progression.

The survey was designed so that all data gathered (from both objective responses and open-ended responses) were anonymous. The survey was designed using the internet survey instrument Research Electronic Data Capture (REDCap), which is a secure, web-based application designed to support data capture for research studies. REDCap provides an intuitive interface for validated data entry; audit trails for tracking data manipulation and export procedures; automated export procedures for seamless data downloads to common statistical packages; and procedures for importing data from external sources.{11}

Data were exported to Excel files and summary data were used to describe results. Three questions solicited open-ended responses about how individuals learned about clinical research career options, how they obtained their first job, and their advice to novices seeking their first job in clinical research. Qualitative methods were used to identify themes from text responses. The project was submitted to the university’s institutional review board and was classified as exempt from requiring board oversight.

A total of 215 survey invitations were sent out to 90 current students and 125 graduates. Five surveys were returned as undeliverable. A total of 48 surveys (22.9%) were completed. Because the survey was designed to collect information from those who were working or have worked in clinical research, those individuals (n=5) who reported (in the first question) that they had never worked in clinical research were eliminated. After those adjustments, the total number completed surveys was 43 (a 20.5% completion rate).

The median age of the participants was 27 (range 22 to 59). The majority of respondents (89%) reported being currently employed as clinical research professionals and 80% were working in clinical research at the time of graduate program entry. The remaining respondents had worked in clinical research in the past. Collectively, participants’ clinical research experience ranged from less than one to 27 years.

Research assistant (20.9%) and clinical research coordinator (16.3%) were the most common first clinical research roles reported. However, a wide range of job titles were also reported. When comparing entry-level job titles of participants to their current job title, 28 (74%) respondents reported a higher level job title currently, compared to 10 (26%) who still had the same job title.

Twenty-four (65%) respondents were currently working at an academic medical center, with the remaining working with community medical centers or private practices (n=3); site management organizations or CROs (n=2); pharmaceutical or device companies (n=4); or the federal government (n=1).

Three respondents (8%) indicated that their employer used individualized development plans to aid in planning for professional advancement. We also asked if their current employer provided opportunities for professional growth and advancement. Among academic medical center respondents, 16 (67%) indicated in the affirmative. Respondents also affirmed growth opportunities in other employment settings, with the exception of one respondent working in government and one respondent working in a community medical center.

Twenty-five respondents indicated membership to a professional association, and of those, 60% reported being certified by either the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

Open-Ended Responses

We asked three open-ended questions to gain personal perspectives of respondents about how they chose clinical research as a career, how they entered the field, and their advice for novices entering the profession. Participants typed narrative responses.

“Why did you decide to pursue a career in clinical research?”

This question was asked to find out how individuals made the decision to initially consider clinical research as a career. Only one person in the survey had exposure to clinical research as a career option in high school, and three learned about such career options as college undergraduates. One participant worked in clinical research as a transition to medical school, two as a transition to a doctoral degree program, and two with the desire to move from a bench (basic science) career to a clinical research career.

After college, individuals either happened across clinical research as a career “by accident” or through people they met. Some participants expressed that they found clinical research careers interesting (n=6) and provided an opportunity to contribute to patients or improvements in healthcare (n=7).

“How did you find out about your first job in clinical research?”

Qualitative responses were solicited to obtain information on how participants found their first jobs in clinical research. The major themes that were revealed are sorted in Figure 1.

Figure 1: How First Jobs in Clinical Research Were Found

Some reported finding their initial job through an institution’s job posting.

“I worked in the hospital in the clinical lab. I heard of the opening after I earned my bachelor’s and applied.”

Others reported finding about their clinical research position through the internet. Several did not know about clinical research roles before exploring a job posting.

“In reviewing jobs online, I noticed my BS degree fit the criteria to apply for a job in clinical research. I knew nothing about the field.”

“My friend recommended I look into jobs with a CRO because I wanted to transition out of a production laboratory.”

“I responded to an ad. I didn’t really know that research could be a profession though. I didn’t know anything about the field, principles, or daily activities.”

Some of the respondents reported moving into a permanent position after a role as an intern.

“My first clinical job came from an internship I did in my undergrad in basic sleep research. I thought I wanted to get into patient therapies, so I was able to transfer to addiction clinical trials from a basic science lab. And the clinical data management I did as an undergrad turned into a job after a few months.”

“I obtained a job directly from my graduate school practicum.”

“My research assistant internship [as an] undergrad provided some patient enrollment and consenting experience and led to a CRO position.”

Networking and referrals were other themes that respondents indicated had a direct impact on them finding initial employment in clinical research.

“I received a job opportunity (notice of an opening) through my e-mail from the graduate program.”

“I was a medical secretary for a physician who did research and he needed a full-time coordinator for a new study.”

“I was recommended by my manager at the time.”

“A friend had a similar position at the time. I was interested in learning more about the clinical research coordinator position.”

“What advice do you have for students and new graduates trying to enter their first role in clinical research?”

We found respondents (n=30) sorted into four distinct categories: 1) a general attitude/approach to job searching, 2) acquisition of knowledge/experience, 3) actions taken to get a position, and 4) personal attributes as a clinical research professional in their first job.

Respondents stressed the importance of flexibility and persistence (general attitude/approach) when seeking jobs. Moreover, 16 respondents stressed the importance of learning as much as they could about clinical research and gaining as much experience as they could in their jobs, encouraging them to ask a lot of questions. They also stressed a broader understanding of the clinical research enterprise, the impact that clinical research professional roles have on study participants and future patients, and the global nature of the enterprise.

“Apply for all research positions that sound interesting to you. Even if you don’t meet all the requirements, still apply.”

“Be persistent and flexible. Be willing to learn new skills and take on new responsibilities. This will help develop your own niche within a group/organization while creating opportunities for advancement.”

“Be flexible with salary requirements earlier in your career and push yourself to learn more [about the industry’s] standards [on] a global scale.”

“Be ever ready to adapt and change along with your projects, science, and policy. Never forget the journey the patients are on and that we are here to advance and support it.”

“Learning the big picture, how everything intertwines and works together, will really help you progress in the field.”

In addition to learning as much as one can about roles, skills, and the enterprise as a whole, advice was given to shadow or intern whenever possible—formally or through networking—and to be willing to start with a smaller company or with a lower position. The respondents stressed that novices entering the field will advance in their careers as they continue to gain knowledge and experience, and as they broaden their network of colleagues.

“Take the best opportunity available to you and work your way up, regardless [if it is] at clinical trial site or in industry.”

“Getting as much experience as possible is important; and learning about different career paths is important (i.e., not everyone wants or needs to be a coordinator, not everyone goes to graduate school to get a PhD, etc.).”

“(A graduate) program is beneficial as it provides an opportunity to learn the basics that would otherwise accompany a few years of entry-level work experience.”

“Never let an opportunity pass you up. Reach out directly to decision-makers via e-mail or telephone—don’t just rely on a job application website. Be willing to start at the bottom. Absolutely, and I cannot stress this enough, [you should] get experience at the site level, even if it’s just an internship or [as a] volunteer. I honestly feel that you need the site perspective to have success at the CRO or pharma level.”

Several personal behaviors were also stressed by respondents, such as knowing how to set boundaries, understanding how to demonstrate what they know, and ability to advocate for their progression. Themes such as doing a good job, communicating well, being a good team player, and sharing your passion also emerged.

“Be a team player, ask questions, and have a good attitude.”

“Be eager to share your passion and drive. Although you may lack clinical research experience, your knowledge and ambition can impress potential employers.”

“[A] HUGE thing is learning to sell yourself. Many people I work with at my current CRO have such excellent experience, and they are in low-level positions because they didn’t know how to negotiate/advocate for themselves as an employee.”

This mixed-methods study used purposeful sampling of students in an academic clinical research program to gain an understanding of how novices to the field find their initial jobs in the clinical research enterprise; how to transition to a clinical research career; and how to find opportunities for career advancement. There are multiple clinical research careers and employers (see Figure 2) available to individuals working in the clinical research enterprise.

Figure 2: Employers and Sample Careers

Despite the need for employees in the broad field of clinical research, finding a pathway to enter the field can be difficult for novices. The lack of knowledge about clinical research as a career option at the high school and college level points to an opportunity for broader inclusion of these careers in high school and undergraduate curricula, or as an option for guidance counselors to be aware of and share with students.

Because most clinical research jobs appear to require previous experience in order to gain entry, novices are often put into a “Catch-22” situation. However, once hired, upward mobility does exist, and was demonstrated in this survey. Mobility in clinical research careers (moving up and general turnover) may occur for a variety of reasons—usually to achieve a higher salary, to benefit from an improved work environment, or to thwart a perceived lack of progression opportunity.{9}

During COVID-19, there may be hiring freezes or furloughs of clinical research staff, but those personnel issues are predicted to be temporary. Burnout has also been reported as an issue among study coordinators, due to research study complexity and workload issues.{12} Moreover, the lack of individualized development planning revealed by our sample may indicate a unique workforce development need across roles of clinical research professionals.

This survey study is limited in that it is a small sample taken specifically from a narrow cohort of individuals who had obtained or were seeking a graduate degree in clinical research at a single institution. The study only surveyed those currently working in or who have a work history in clinical research. Moreover, the majority of respondents were employed at an academic medical center, which may not fully reflect the general population of clinical research professionals.

It was heartening to see the positive advancement in job titles for those individuals who had been employed in clinical research at program entry, compared to when they responded to the survey. However, the sample was too small to draw reliable correlations about job seeking or progression.

Although finding one’s first job in clinical research can be a lengthy and discouraging process, it is important to know that the opportunities are endless. Search in employment sites such as Indeed.com, but also search within job postings for targeted companies or research sites such as biopharmguy.com (see Table 1). Created a LinkedIn account and join groups and make connections. Participants in this study offered sound advice and tips for success in landing a job (see Figure 3).

Table 1: Sample Details from an Indeed.Com Job Search

Note: WCG = WIRB Copernicus Group

Figure 3: Twelve Tips for Finding Your First Job

• Seek out internships and volunteer opportunities
• Network, network, network
• Be flexible and persistent
• Learn as much as possible about clinical research
• Consider a degree in clinical research
• Ask a lot of questions of professionals working in the field
• Apply for all research positions that interest you, even if you think you are not qualified
• Be willing to learn new skills and take on new responsibilities
• Take the best opportunity available to you and work your way up
• Learn to sell yourself
• Sharpen communication (written and oral) and other soft skills
• Create an ePortfolio or LinkedIn account

Being willing to start at the ground level and working upwards was described as a positive approach because moving up does happen, and sometimes quickly. Also, learning soft skills in communication and networking were other suggested strategies. Gaining education in clinical research is one way to begin to acquire knowledge and applied skills and opportunities to network with experienced classmates who are currently working in the field.

Most individuals entering an academic program have found success in obtaining an initial job in clinical research, often before graduation. In fact, the student initiating the survey found a position in a CRO before graduation.

• Sonstein S, Seltzer J, Li R, Jones C, Silva H, Daemen E. 2014. Moving from compliance to competency: a harmonized core competency framework for the clinical research professional. Clinical Researcher 28(3):17–23. doi:10.14524/CR-14-00002R1.1. https://acrpnet.org/crjune2014/
• Sonstein S, Brouwer RN, Gluck W, et al. 2018. Leveling the joint task force core competencies for clinical research professionals. Therap Innov Reg Sci .
• Jones CT, Benner J, Jelinek K, et al. 2016. Academic preparation in clinical research: experience from the field. Clinical Researcher 30(6):32–7. doi:10.14524/CR-16-0020. https://acrpnet.org/2016/12/01/academic-preparation-in-clinical-research-experience-from-the-field/
• Jones CT, Gladson B, Butler J. 2015. Academic programs that produce clinical research professionals. DIA Global Forum 7:16–9.
• Brouwer RN, Deeter C, Hannah D, et al. 2017. Using competencies to transform clinical research job classifications. J Res Admin 48:11–25.
• Stroo M, Ashfaw K, Deeter C, et al. 2020. Impact of implementing a competency-based job framework for clinical research professionals on employee turnover. J Clin Transl Sci.
• Calvin-Naylor N, Jones C, Wartak M, et al. 2017. Education and training of clinical and translational study investigators and research coordinators: a competency-based approach. J Clin Transl Sci 1:16–25. doi:10.1017/cts.2016.2
• Development, Implementation and Assessment of Novel Training in Domain-based Competencies (DIAMOND). Center for Leading Innovation and Collaboration (CLIC). 2019. https://clic-ctsa.org/diamond
• Clinical Trials Talent Survey Report. 2018. http://www.appliedclinicaltrialsonline.com/node/351341/done?sid=15167
• Causey M. 2020. CRO workforce turnover hits new high. ACRP Blog . https://acrpnet.org/2020/01/08/cro-workforce-turnover-hits-new-high/
• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. 2009. Research electronic data capture (REDCap): a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 42:377–81.
• Gwede CK, Johnson DJ, Roberts C, Cantor AB. 2005. Burnout in clinical research coordinators in the United States. Oncol Nursing Forum 32:1123–30.

A portion of this work was supported by the OSU CCTS, CTSA Grant #UL01TT002733.

Bridget Kesling, MACPR, ( [email protected] ) is a Project Management Analyst with IQVIA in Durham, N.C.

Carolynn Jones, DNP, MSPH, RN, FAAN, ( [email protected] ) is an Associate Professor of Clinical Nursing at The Ohio State University College of Nursing, Co-Director of Workforce Development for the university’s Center for Clinical and Translational Science, and Director of the university’s Master of Clinical Research program.

Jessica Fritter, MACPR, ( [email protected] ) is a Clinical Research Administration Manager at Nationwide Children’s Hospital and an Instructor for the Master of Clinical Research program at The Ohio State University.

Marjorie V. Neidecker, PhD, MEng, RN, CCRP,  ( [email protected] ) is an Assistant Professor of Clinical Nursing at The Ohio State University Colleges of Nursing and Pharmacy.

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Clinical Research Quiz Questions And Answers!

When it comes to health and illness, clinical research comes into role. To check your knowledge on the same, you can take this clinical research quiz. Basically, clinical research involves the prevention, diagnostics, and treatment of a specific illness. Most of the clinical research is done in labs with samples of human specimens. This quiz will help you increase and check your knowledge about clinical research. Take the quiz and share the result! All the best!

What are the documents mandatory to enroll in a clinical research study?

Case Report Form

Informed Consent Form

Investigator's Brochure

Rate this question:

Preclinical studies are conducted on animals and artificial cells in labs.

A clinical research study is conducted in how many phases, to begin with a clinical research study, it is mandatory to get approval from.

Both regulators and ethics committees both

Tuskegee syphilis study was done from 1932 till 1972.

Neonatal deaths happened as a result of the thalidomide tragedy., the ……….. is an institution or individual who initiates, manages and finances a clinical trial., in clinical research studies, conflict of interest is a risk factor for scientific misconduct., who is responsible for preparing essential documents like protocol/ investigators brochure/ informed consent form/ case report form during clinical trials.

Investigator

Ethics committee

Adverse Drug Reaction reporting is mandatory during clinical trials.

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Guest Column | November 24, 2020

Starting a career in clinical research: 7 things we wish we knew.

By Laurie Halloran and Michelle Pratt, Halloran Consulting Group, Inc.

This experience has shaped my passion for clinical research education at all levels and my vow to pay it forward. I try to consistently work on initiatives that bring better learning opportunities and more defined competencies and standards to clinical research roles. – Laurie Halloran

In recent years, careers in clinical research have become more plentiful and the opportunities for formal clinical research education are more accessible. The industry, however, is still looking at a talent shortage that could become acute in the next decade. 1 A main contributor to this shortage is a lack of focused intervention at every level to identify the skills, behaviors, and knowledge that will enable motivated candidates to begin and mature their careers in the industry. The real challenge clinical research professionals face at every stage on their career paths is the need to be two things: technically astute (e.g., regulatory knowledge, medical/pathophysiology expertise, data science, technology solution navigation) and emotionally intelligent. These two components of clinical research professionals are pivotal to the success at every level. The intent of this three-part series is to provide insight and guidance to help professional clinical researchers effectively navigate their careers.

Entry-Level Clinical Research Positions And Potential Career Paths

A clinical research coordinator (CRC) 2 works under the direction of a principal investigator (PI) at a clinical site to coordinate and facilitate the daily clinical research activities, including screening and recruiting patients, collecting and recording data, and maintaining study documentation. Working at the site provides a different perspective of clinical research than a CRA or clinical trial associate (CTA) role. Progression on the site side of clinical research typically starts with more senior CRC roles, CRC manager, and, depending on the size of the research site, even leading an entire research department. Many CRCs also move to the industry side of clinical research into a CTA or CRA role.

CTA is a position that supports management of clinical trials under the direction of the clinical trial manager (CTM). In this role, a CTA gains exposure to many aspects of trial management, including working directly with study plans and timelines, vendor oversight, patient enrollment, regulatory documentation, and oversight of the trial master file (TMF) (all study documentation). Many CTAs advance their career though more senior CTA roles, CRA roles, and eventually as CTM or clinical project manager (CPM).

A CRA 3 is the most commonly available clinical research position. In this role, a CRA acts as a liaison between the clinical trial management and the clinical sites that are enrolling subjects. The main responsibilities are clinical monitoring, overseeing the progress of the clinical trial at the site and ensuring that it is being conducted appropriately. The daily focus is on protocol and regulatory compliance, data reliability, and the proper care, treatment, and safety of patients. Many CRA positions can be found at contract research organizations (CROs); however, some sponsor companies also have typical CRA roles or an in-house CRA position. In terms of career development, a CRA typically progresses up through more senior CRA roles to team lead, CRA manager, or potentially to CPM.

Any of these positions is a great way to get into clinical research. Each of these positions provides an education on all elements of clinical research and a foundation for future roles and growth in the industry. By getting this broad view, you will be able to learn more about the specific aspects of clinical research that interest you so you can tailor your career path 4 in that direction. In addition, try to identify an area that continues to challenge you and helps you grow.

If you are interested in exploring different options, we suggest visiting the ACRP’s Find Your Element campaign. 5

Advice From Former Entry-Level Candidates

While the behaviors and skills expected for an entry-level position in clinical research are similar to those that would be expected of any professional candidate, the importance of patient safety, the volatility of the industry, and the number of technical skills you must develop in a short period of time are challenges unique to the life sciences space. For those who have not had any formal training in clinical research, here are seven insights that would have been helpful at the beginning of our careers.

1. Patient Safety Drives All the Work You Do

Clinical research has strict regulations worldwide that have been inspired by key historical events (e.g., Tuskegee syphilis experiments, Jesse Gelsinger’s death). 6,7,8 Change has often come following tragedy or public outcry. Understanding the historical context helps you understand why clinical research is differentiated from other experimentation. Also, it is important to understand that whether or not you are working directly with patients, you can impact patient safety.

2. Understand the “Whys”

You can work in this industry for a long time and never be directly involved in drug or device development. Review the drug discovery and development process 9 to understand the different phases of development and associated regulations. Figure out where your position fits into this process and why it is important. Become familiar with the roles of the different departments in your company and why you need to interact with them. Understanding the bigger picture, emphasizing the reason why every responsibility you have, regardless of career level, is meaningful and important to help you understand why the clinical trial you are working on is being done.

3. Learn your GxPs

Good practice quality guidelines 10 ensure that your drug or device is safe and functions as expected. Having at least a high-level understanding of these guidelines will help you approach your work with a quality mindset and support a culture of quality at your company.

4. If It Is Not Documented, It Didn’t Happen

Everything in clinical research must be documented, and document control is not optional. All companies should have standardized processes for the preparation, recording, and correction of data as well as the maintenance of the records throughout the life cycle of a document. Be organized in your document filing and don’t put your TMF filing and maintenance on the back burner.

5. You Will Have Many Questions

In this industry, you will never have all the answers, regardless of how experienced you are. Questions not only help you but help study team members or sites who “don’t know what they don’t know.” Question things that do not make sense operationally (e.g., ask if a procedure is really necessary when developing a protocol), always considering the patients, the big picture, and your objectives.

6. Communication Skills Are Key 11

With so many moving parts in clinical research, having effective communication habits is necessary. Educational programs do not necessarily set you up with the soft skills 12 that you need when entering the workforce. Become familiar with the concept of soft skills and when you join a company, take the time to understand their communication best practices.

7. You Are the Driver of Your Career

Larger companies in the industry may have a developed training program; however, at many smaller companies you will be learning on the job. Be as proactive as you can to create a network and a system of support (e.g., a coach or mentor). Volunteer for opportunities outside of your comfort zone, mentor others, and learn as much as you can. Advocate for yourself and try not to compare yourself to others, as there are so many different needed skillsets in this industry. Find a path that feels like the right fit, based on your strengths and passions.

As an individual contributor in clinical research, your speed, high-quality results and deliverables, proactivity in keeping management informed, and attention to detail are all equal. Different skills, abilities, and insights will be needed depending on if you would like to continue in a contributing role or move toward management and leadership. In our next installment of this series, we will discuss the transition from an individual contributor to a management role.

References:

• https://www.pharmavoice.com/article/2016-11-talent-war/
• https://forteresearch.com/news/roles-and-responsibilities-of-a-clinical-research-coordinator/
• https://clinicalresearchfastrack.com/clinical-research-associate-career/
• https://tracs.unc.edu/index.php/services/education/careers
• https://careersinclinicalresearch.org/
• https://blog.lillytrialguide.com/clinical-trial-history-regulations-regulatory-guidelines-requirements/
• http://cdn2.hubspot.net/hub/149400/file-410979295-pdf/docs/CRT_Timeline_download.pdf
• https://clinicalcenter.nih.gov/recruit/ethics.html
• https://www.nebiolab.com/drug-discovery-and-development-process/
• https://www.ich.org/page/quality-guidelines
• https://www.indeed.com/career-advice/resumes-cover-letters/communication-skills
• https://www.indeed.com/career-advice/resumes-cover-letters/soft-skills

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