LOOKING FOR A CHALLENGING and rewarding career change? Consider transitioning from the clinical setting to the research field by becoming a clinical research coordinator (CRC). Sometimes called a study coordinator, research nurse coordinator, or nurse researcher, the CRC plays a key role in the clinical trial process. Because of the growth in the research industry, with its obligation to provide sound evidence-based treatment, the number of nurses moving into the role of the CRC is increasing dramatically.1
This article will explore the career pathway of a CRC, including how to make the transition from clinician to CRC. First, let's look at the role in more depth.
Who's on first?
Although research involves a whole team, the principal investigator (PI) and the CRC are key players. The PI assumes full responsibility for the conduct of the research study and oversees all aspects of the study, including training staff, administering informed consent, and protecting participant confidentiality.
The CRC, who is hired by the PI, often has the responsibility of aiding in the coordination, management, and conduct of clinical research.2 Like the unit charge nurse in a hospital, the CRC needs to look at the big picture, plan for small details, delegate tasks, manage time, and remember that the primary outcome is to improve patient care.
CRCs may be employed in various settings, including medical practices conducting research, organizations dedicated to research, and academic sites, which are usually affiliated with a university hospital. Although it's not required, most CRCs have a healthcare background, especially in nursing. Many CRCs have an associate's or bachelor's degree, and some have a master's degree, depending on the requirements of the specific position. Institutions conducting research often provide additional education for new CRCs.
Making the transition
Although transitioning from the clinical setting to the research field isn't difficult, it's a huge change from bedside nursing. Spilsbury and colleagues explored the scope and potential contribution of the CRC by conducting a focus group interview with 16 clinical research nurses.3 All 16 participants agreed that the research role is very different from the clinical role and that time is needed for the transition.
The CRC handles a diverse range of activities, including administrative, business, medical/nursing, and patient care duties. The CRC, like the clinical nurse, needs self-confidence, flexibility, and the ability to adapt to change. To comply with regulations and policies, the CRC must also pay close attention to details.
Fostering and maintaining good relationships will aid in recruitment and retention of study subjects (patients) and create an atmosphere of professionalism. A CRC also needs good people skills for dealing with representatives of sponsor companies, medical directors, administrators, and others involved in the study.
A successful transition involves multiple steps or stages. The first step is learning to think like a researcher rather than a clinician. Many nurses feel a need to fix things. Although CRCs wouldn't ignore an unsafe situation, they can't practice direct care because doing so could influence study results. For example, offering an opinion or advice to a subject involved in a study could skew the results.
A second step is to adapt to functioning independently. As a nurse, you're already used to thinking independently and delegating tasks, but as a CRC, you may be the sole person working on an area of the project.
Knowing and accepting Murphy's Law—if it can go wrong, it will—will help ease frustrations. The CRC needs to be flexible, especially to recruit and retain subjects. For example, it's not unusual to work diligently to schedule appointments for study participants only to have some no-shows. Also, studies frequently involve people who have unpredictable schedules because they're very sick.
One of the biggest challenges for a nurse becoming a CRC may be to gain and use skills in data management. Although undertaking course work in statistics and being familiar with statistical software may help, it may not adequately prepare you for managing data day to day.
Quite commonly, research studies require as many as 25 forms, and each subject may complete these multiple times over the course of the study. The CRC must be vigilant to enter all of these data into the database. The CRC will need to establish checks and balances for receipt of data, data entry, and verification of entry before the study begins.
Advantages and disadvantages
If you think you have the skills needed to become a CRC, take some time to consider the pros and cons. Because CRCs don't need to adhere to a rigid schedule, they have flexibility in their work schedules. The downside is that CRCs have to be available for study participants on evenings or weekends if needed.
Intellectual stimulation is an advantage of this job. Often the CRC will be involved with very bright people, and interacting with them can be exciting and inspiring. The position isn't as physically demanding as direct patient care, which is an advantage for nurses with physical challenges.
You may consider the salary for a CRC position a disadvantage because it may be less than you'd earn as a clinician. However, autonomy, flexibility in work schedule, and opportunities for learning may offset the disparity.
Needing to learn specialized clinical and technical skills, such as working with unfamiliar software packages, can be an advantage or a disadvantage, depending on your interests and your ability to pick up new skills quickly.4,5
If you decide to transition into a CRC role, choose an area of research that interests you. Then find a mentor, such as a faculty member or a supervisor or nurse educator. Their expertise and support will be invaluable. To get your foot in the door for your first job, consider taking a position as a nurse interventionist on a research study. This research nurse carries out the intervention that's under investigation in the clinical trial. Many organizations prefer to hire someone new to research for this position so he or she won't have preconceived biases.
Because the field is always changing, consider continuing your education. Further education will not only enhance your work performance, but it will also increase your market worth. Many colleges and universities offer certificate programs at a post-baccalaureate or graduate level, and most can be undertaken part time.
Certification may also help you advance in your career. Two organizations provide certification for the CRC: the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SoCRA). ACRP offers the designation of Certified Clinical Research Coordinator and SoCRA offers the Certification Program for Clinical Research Professionals.
Growth comes with experience. The key is to find that first job, be confident in the skills you already possess, and be ready for new opportunities. Your best reward may come when your contributions to sound evidence-based research lead to improved patient outcomes.
1. Yin CX. Improving the quality of clinical research: recognizing issues in training. Research Practitioner.http://goliath.ecnext.com/coms2/gi_0199-7508150/Improving-the-quality-of-clinical.html
2. Woodin KE. The CRC's Guide to Coordinating Clinical Research
. Boston, MA: CenterWatch; 2004.
3. Spilsbury K, Petherick E, Cullum N, Nelson A, Nixon J, Mason S. The role and potential contribution of clinical research nurses to clinical trials. J Clin Nurs
4. Mueller MR, Mamo L. The nurse clinical trial coordinator: benefits and drawbacks of the role. Res Theory Nurs Pract
5. Roberts BL, Rickard CM, Foote J, McGrail MR. The best and worst aspects of the ICU research coordinator role. Nurs Crit Care
Fedor CA, Cola PA, Pierre C. Responsible Research A Guide for Coordinators
. London; Chicago, IL: Remedica; 2006.