The Evolution Of A Clinical Research Coordinator
By Dan Schell, Chief Editor, Clinical Leader
Like many people in this industry, Briana White admits that her career in clinical research was more accidental than planned. “I first heard about clinical research from an advisor while working on my undergraduate degree,” she explains. “At the time, I didn’t think much about it because my plan was to go onto med school. Eventually I decided against med school, but I still wanted to stay in the healthcare field. That’s when I remembered that conversation about clinical research.”
After graduating, she spent a little time as a medical assistant at a local physician’s office and then decided to take a research specialist course at a local community college. [White notes that this was just a certificate program, and that other colleges like Durham Technical College offer two-year programs in clinical research.] Feeling this was the path she wanted to pursue, she joined the Facebook page for Black Women in Clinical research. There, she posted that she was looking for a CRC position and asked for any assistance on landing a job. Surprisingly, she found exactly what she was looking for, and it was only about 10 minutes from where she lives in Smithfield, NC!
IT STARTS WITH ON-THE-JOB TRAINING
That was four years ago, and since then she has been the study coordinator at Superior Clinical Research, which has a primary site and four satellites in more rural nearby areas. Approximately 73% of Superior’s typical patient demographic are African American. Beyond that, about 15% are Hispanic, 8% are white, and the remaining are a mix of categories such as pacific islander and native American. With those types of diverse demographics, it’s no wonder many of the trials Superior works on are for TAs such as diabetes and hypertension. However, White notes that the site really is multitherapeutic, having run trials for narcolepsy, autoimmune diseases, lupus, rheumatoid arthritis, respiratory-related conditions, and idiopathic pulmonary fibrosis.
She says, at first, there was a lot of on-the-job training, with her really leaning on the site’s research director and research assistant for guidance. After she had been there awhile, they decided to develop a more structured training program. “We’re not a big site, so we all support each other in terms of what my role looks like,” she explains. “We’re not departmentalized where certain people strictly handle things like data, regulatory, or patient visits; it’s all shared, which is now part of the training.”
HOW MUCH TECH IS TOO MUCH?
No matter how big a site is, there’s usually one challenge that surfaces when talking with any site personnel — technology sprawl and its corresponding training issues. Especially for a site like Superior that uses paper source, during study startup, having to learn six or seven different systems each with their own password all while you’re running 5-7 other trials at the same time, can be frustrating, to say the least.
“We have one study right now that uses only three systems, and I thought that was amazing,” White says. “But then we have others that use seven. I keep wondering, why do we need all of this? And the worst part is that these disparate systems don’t talk to each other; they're not integrated. That is one way to make things more efficient and easier for coordinators and anyone at a site who’s handling data. Everyone in clinical research always wants everything fast or immediately. Integrating at least some of this technology sure would go a long way in helping.”
Beyond technology challenges, White says there are the typical budgeting and contract challenges to deal with. For example, they recently had a sponsor that didn’t want to pay for monitoring visits, and specifically, those done remotely, because they felt they were part of the site’s normal regulatory requirements. As Dr. Daniel Fox of CRPN noted in my recent interview with him, the amount of time and effort associated with monitoring visits, including uploading (as with a paper-based site) info to the required systems, is “…only invoiceable if you negotiate them in your contract.”
SITE & COMMUNITY CONNECTIONS
When an issue comes up that White and the Superior staff would like to get another opinion on, they often contact other sites they’ve developed relationships with over the years. They may have questions, for example, on how the other site deals with a specific sponsor or CRO, or it may be a technology problem or an issue with patient recruitment or retention. Often, these relationships start when they encounter a patient during screening who wants to participate but is from a different state or locale. In those instances, the Superior staff will search clinicaltrials.gov and find the nearest research site to the patient and call the site with the referral. “This helps us build valuable connections with fellow sites,” White says. “Even when we go to conferences like SOS, one of our goals is to connect with as many sites as we can to let them know that we are in this together and figure out how can we support each other, whether by referrals for a study or some other aspect of running a site.”
Connecting with their community is also a big focus for Superior. During our interview, White often mentioned the importance of community-based research, which she describes as looking at the community as a partner in advancing research and study design. In fact, this was the topic of Superior’s recent LinkedIn Live Coffee and Conversations webinar episode, which White cohosts. Other past topics have included strategies for sites to attract more inclusive trial participants, how heart health relates to research, and women’s health. The site also sponsors or gets involved with community events such as health fairs and CPR training.
“Focusing on the community component has really helped us with trial participants,” White says. “It enables us to show the community who we are and what we do. It’s because of those relationships that we end up getting so many referrals from people who've already participated in our research.”
Many CRCs at larger sites frequently lament about the fast-paced nature of the job and the seemingly never-ending battle between providing the best patient care/interaction possible while also ensuring any data input meets quality standards. White can relate, although she enjoys the balance between patient-facing duties and those that are more administrative. “Over the years, one thing I’ve learned is the art of completing your workday and leaving all those emotions and stress behind. It took me awhile to get to that point, though.”