The Study Coordinator (SC)-CRA relationship is pivotal to site success.
The critical development and management of this partnership requires patience, productivity and transparency by both participants. The relationship dynamic between CRAs and SCs is as diverse as the therapeutic indications in which they work, and can range from sharing a friendship outside the workplace to keeping it strictly business at work. Ultimately, despite the variables, the shared goals of patient safety and accurate data drive the success of the partnership.
Site management is a joint effort of the SC and CRA; neither role is superior or subordinate. Their individual contributions form the cohesive structure of site management. The two individuals clean data, resolve queries and ensure GCP compliant study conduct. One is incomplete without the other—one requires the other to resolve, complete and fulfill all study requirements. The dynamic assures strong, successful performance, just as adversarial or passive behavior contribute to negative study performance.
I learned early on the importance of being able to work through personality conflicts to ensure the success of a clinical trial. You do not have to like the CRA or SC, as long as your goals are aligned. It truly is an accomplishment if results are produced despite personal conflict.
This applies to each step of the monitoring process, particularly when making a first impression during site selection. How a Principal Investigator (PI) and staff present their facility, equipment and research process, their level of feedback and their professionalism will determine selection—not their ability to make small talk or crack jokes.
In a recent discussion at a pre-study visit, a PI and an SC spoke about their unfortunate experience with several prior monitors. This particular PI was extremely conscientious about his responsibility and oversight. He was available at every monitoring visit to speak to the CRA about the study and site performance. He would actively solicit feedback to improve processes at his site. He was vested in the site/CRO/sponsor partnership, which contributed to his success.
For example, it was important to him that the CRA and his staff work together to resolve findings and queries during monitoring visits, as opposed to the common practice of the CRA documenting a list of findings for the SC to address before the next monitoring visit. This process was communicated to each monitor the site hosted to promote efficiency, communication and respect. As a monitor, I would have had no problem spending extra time with the SC to address my findings if it made data retrieval more efficient and timely, a win-win for all parties.
Yet despite repeated requests, the site’s last several monitors had left long lists of queries but no time to assist staff in resolving them. Taking this small extra step would have strengthened the relationship between the site and the CRA.
As a new monitor, I learned the importance of putting aside my pride for the greater good of the trial. I was assigned a well-known, and quite challenging, site for an oncology study. The site director was known to raise her voice to her staff and to any unsuspecting monitor on her radar. I got a knot in my stomach at just the thought of dealing with her. The first several monitoring visits were extremely frustrating. I did not yet understand the importance of compromise, empathy and open dialogue to discuss unfair treatment. As a result of my stubbornness, I was given the worst monitoring schedule and the smallest work area.
Another monitor working at the site had worked successfully with the director for years. She observed my interactions and my frustration, and gave me some sage advice: to compromise with the director and recognize each small victory I may have gained by not giving in hindered trial performance and prolonged my frustration. She advised me to listen and find common ground with the director for the success of the trial. At my wits’ end, I followed her advice and redirected my approach. I listened and, as a consequence, developed empathy. I learned the director’s bark was worse than her bite. She merely asserted her authority when dealing with new individuals but backed off once she trusted and respected the relationship.
I learned a lot from that experience: I never called the director a friend, but in swallowing my pride I gained a healthy respect for her experience and strength. It resulted in a more peaceful and productive relationship, and I earned a better monitoring schedule, faster data retrieval and more respect from the site overall.
The most important lesson from this experience: no matter how seemingly insurmountable a conflict, the key is to find a common ground for the greater good of the trial.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and business development director. She has written and edited newsletters for CROs, created training curriculum and writes for several research publications. She currently works in relationship development/study startup in the CRO industry.
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