Everyone pursues a nursing career for slightly different reasons, but at its core, we’re all striving for one basic goal—to help our patients be healthier and live a longer, fuller life. Of course, there are a number of roles we can take on to achieve this goal, some of which you may not be particularly familiar with. Research nursing is perhaps one of these less talked about career paths, but one that can be extremely rewarding professionally and personally.
Seventeen years ago, I began my nursing career as an oncology/HIV nurse, later transitioning onto a surgical service team and then to a post-anesthesia care unit. Worn out by too many long “on call” shifts, I decided to transition into research nursing, which provides a more predictable schedule and no on-call requirements.
I began as a research nurse in a private practice that focused on allergy, asthma, immunology, and rheumatology. There was a lot of new information thrown at me in my initial months as I learned about the necessary regulations and compliance requirements of clinical research while still maintaining a regular schedule of patients. Dealing with pharmaceutical clinical trials, there was a more rigid flow to these patient visits as I was required to perform specific assessments, document their results, and record lots of information based upon specific study protocols. I obtained my certified research coordinator status after 2 years, which cemented my proficiency in the field.
The National Institutes of Health defines a clinical trial as one in which “one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”1 These clinical trials range from small tolerability or exploratory studies (phase 1 trials) all the way through large studies to assess short- and long-term safety and efficacy (phase 3 or 4 trials).
Pharmaceutical companies are involved in the majority of these trials as the direct or indirect study sponsor, developing the study protocol, creating consent documents, and identifying vendors/sites to help enroll patients and collect data. Some trials are funded by government agencies, foundations, or individual investigators themselves. Regardless of the source of the trial, the role of the research nurse and the larger research team is similar.
Every trial has a study coordinator who is appointed to guide the team of principal investigators, bench scientists, lab personnel, other physicians, and nurses, and to ensure that the study protocol and principals of human research trials are followed. The safety of clinical trial subjects is always at the forefront of any clinical trial as these are patients potentially being given a drug whose effects—both positive and negative—are not fully known. There are medical review and safety monitoring boards who periodically review the progress of clinical trials to ensure that the team is adhering to the study protocol, following appropriate regulations, and maintaining subject safety.
In my current role as a research nurse at the University of Rochester Division of Medicine in Allergy, Immunology, and Rheumatology, I am involved in a variety of clinical studies looking into the basic science of inflammatory and rheumatic diseases. These studies are looking at human cell science (bone, biopsies, and blood samples) to try to identify biomarkers that can help define a disease process or predict prognosis for patients. This would then be translated into identifying new treatment options for a specific disease or syndrome.
My daily responsibilities vary of course, but typically involve some combination of the following:
- Reviewing medical records to determine whether interested patients meet inclusion criteria for specific studies.
- Budgeting and documenting study finances. This includes day-to-day supplies, specialty services charges, and subject reimbursement for items such as travel.
- Creating study documents for subject visits that detail all assessments to be completed at the visit.
- Ordering, scheduling, and documenting results from study-specific testing such as ultrasounds of inflamed joints, biopsies of affected or healthy tissue, and blood draws that may be required to determine the presence or absence of specific biomarkers in a subject’s blood and/or tissue.
- In conjunction with the principal or co-principal investigator, obtaining patient medical histories, lab draws, taking vital signs, teaching medication administration protocols, and other patient-related responsibilities.
- Entering results from subject visits and study assessments into an electronic database or spreadsheet.
One of the most rewarding parts of my job is playing a role in cutting-edge research. For example, one of our current studies is looking at markers in the blood or skin of psoriasis patients to determine if that patient is at risk of developing psoriatic arthritis. The study includes collecting skin biopsies, completing blood draws, and performing ultrasound testing. There are also multiple joint, psoriasis, and pain assessments that need to be performed on a set schedule. Findings from all of these components need to be documented and logged into a database on a regular basis.
I find that there are a variety of reasons why patients (or research subjects as they are often called in these studies) agree to take part in clinical trials. Many have failed multiple previous medications and are still dealing with significant symptoms. Some could not afford the necessary co-pays for their medications (in clinical trials, medications are free to all research subjects). Some appreciate the value of clinical research and potentially helping other patients with their condition in the future. The reputation and demeanor of the referring physician or principal investigator may also be a factor.
I now have more than a decade of experience as a research nurse and study coordinator. It’s true that there is a lot of paperwork and material to document, but my day-to-day role is both interesting and rewarding. I have learned to multitask effectively and balance face time with patients along with time at my desk. Being a good research nurse requires a strong base of medical and medication knowledge along with computer proficiency.
Every year, I find that there are frequent opportunities to advance my personal education and improve my skills as a research nurse. It helps to work with a team of smart professionals who share my passion for learning and advancing the practice of medicine. My clinical training certainly has relevance to my responsibilities, but I’ve had to round out my professional repertoire of skills to add the necessary value to my team.
Transitioning from a traditional nursing career into a role as a research nurse is certainly not for everyone. It requires mental flexibility, attention to detail, organization, and a love (or at least a tolerance) for data entry. But for those nurses who value a structured professional schedule and enjoy playing a role in developing areas of medicine, it is definitely a viable career with many rewards.
Amy Wielgosz, RN, CCRC, is a clinical research nurse at the University of Rochester Medical Center in Rochester, NY. She graduated from Genesee Community College in Batavia, NY, with an Associate Degree of Science in Nursing and obtained Registered Nurse licensure thru the state of New York and Clinical Research Coordinator certification thru the Association of Clinical Research Professionals. She is currently working as a Senior Human Subject Research Coordinator in the Research Division of Allergy, Immunology, and Rheumatology at the University of Rochester Medical Center in Rochester, NY, under the direction of Christopher Ritchlin, MD.
1. National Institutes of Health. NIH Clinical Trials Definition. Available at www.nidcd.nih.gov/research/clinical-studies/researchersprofessionals/
clinical-trials-definition. Accessed August 31, 2018.