If “recruiting and screening patients who try new treatments and monitoring and reporting on patient progress” sounds like a reasonable, if skimpy, definition of the duties of a clinical research coordinator (CRC) at a clinical trial site, imagine the surprise of a newly minted CRC who finds themself tasked with exploring a shuttered hospital in search of old research records, or visiting the local jail in hopes of finding participants who have gone missing mid-study.
Dee Tilley, RN, CGRN, CCRC, ACRP-MDP, ACRP-PM, FACRP, a 35-year Clinical Research Nurse at Mercy Health St. Vincent Medical Center in Toledo, Ohio, has experienced both of those situations, and so many more “other duties as assigned” that she never thought would be part of her work on trials when she first earned her Certified Clinical Research Coordinator (CCRC®) designation from ACRP 18 years ago.
Clarifying that she has never had to do anything illegal in pursuit of keeping patients safe and data flowing in studies at her site, Tilley, who is an ACRP Fellow and member of The Academy Board of Trustees, nevertheless recalls how she once went “to a subject’s home with a plain clothes, armed guard to retrieve [the study drug being tested] and do a study visit.” She has also more than once made long road trips with her principal investigator and study supplies “to complete study visits when subjects were unable to return to our office,” and has helped clean out a self-storage unit filled with study records (and all the accumulated grime that came with them) going back 10 years.
Not exactly possibilities that the typical job description for CRCs is likely to include at most sites, you say? Nor, perhaps, are forays into such arenas as site process improvements, quality assurance, safety management, or medical procedure assistance, all of which another CCRC holder told ACRP she has unexpectedly experienced in her work for a trial site. Which isn’t to say that “unexpected” equals “unwelcome” or “irresponsible” where CRC duties are concerned, as some new challenges may go on to become the best parts of a CRC’s routine.
“When I first became a CRC, I never thought that I would be assisting with medical procedures and/or devices,” the anonymous CCRC noted. “Another thing that I never expected to be doing was quality assurance work, which has quickly become my favorite part of the job. I love coming up with innovative ways to improve our department and participant safety, as well.” For example, when participants were signing onto studies in high volumes in the midst of short staffing conditions during the COVID-19 pandemic, she “helped develop a system in which we were able to operate quickly while still ensuring that participant safety was the top priority.”
In their 2021 Clinical Researcher article on “Are Clinical Research Coordinators Recognized as Professionals?,” authors Erika Stevens, MA, FACRP, and Liz Wool, RN, BSN, FACRP, CCRA, CMT, wrote that, “[a]s the number of global clinical trials continues to rise, so does the need and demand for qualified research support personnel, which further drive expectations for clearly established job functions. Variability in the assigned roles and responsibilities among [CRCs] creates opportunity to provide clarity in defining the profession. …The ability to establish a clearly defined career roadmap for the CRC—one based on a thorough understanding of the role’s salient competencies—better enables job performance and provides opportunities for career advancement and credentials to those in the profession.”
The authors may not have meant those “opportunities” to involve things like a CRC setting their alarm for 2 a.m. to call and remind a bedside nurse to draw pharmacokinetic samples from a study participant, or stopping for doughnuts and juice on their way in to work to feed a subject’s six kids so she would come in for her visit, both of which Tilley has done, but a “whatever it takes” attitude will often send one down the right path in this line of work.
Resources:
ACRP Hiring Guidelines for Entry Level Clinical Research Coordinators™
Study: Credentialed Principal Investigators and CRCs Perform Better
9 Reasons Sponsors Should Pay for CRCs to Attend Conferences
Author: Gary Cramer
