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.
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
- Most CRAs work remotely from home and travel frequently:
- This requires being self-motivated and driven
- Sometimes performing a combination of onsite and remote monitoring
- Frequent communication with sites between visits:
- Email, etc.
- 60-80% travel possibility:
- 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
- Traditional onsite monitoring:
- Annual or semi-annual visits based upon the monitoring plan
- Risk-based monitoring/central monitoring
- Remote monitoring
- In-house CRAs and regulatory CRAs
- Types of monitors:
- 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