Professional unity is key
A diverse group that shares the same vision and successfully collaborates to achieve the common goal is the truest form of professional unity.
I have twice had the privilege of working on a specialized team that exemplified unity with their commitment to each endeavor: A team of clinical research associate (CRAs), with members selected for their unique skill set that benefitted the group dynamic. My colleagues were highly trained; our collaborations advanced my research training better than any classroom curriculum.
- Choose CRAs with a minimum of five years of monitoring experience.
- Choose senior CRAs or above; they often have team management experience.
- Choose CRAs that have SWAT or co-monitoring experience, and who have extensive
- experience in conducting all study visit types (pre-study visit, site initiation visit, monitoring visit and closeout visit).
- Choose CRAs that have strong presentational skills—creating and delivering content—for they will need to learn and understand clinical content very quickly within this environment.
- Choose CRAs who have worked across all study indications and study phases.
The first experience occurred 10 years ago. Our CRA team was dedicated to co-monitoring and training. We assisted understaffed, high-profile project teams (due to interim analysis or high-enrolling sites) with site selection, initiation and monitoring visit conduct. The need was very quick, and often last-minute, which required a rapid assimilation of study data. Our unspoken mission statement was “take a protocol and go.” Our CRA team was experienced in a diversity of therapeutic indications and study phases, which enabled effective assistance to all project teams. The level of dedication demonstrated by my colleagues motivated my best performance. As the project assignments were very challenging, the team members collectively supported the individual effort of each CRA with logistical and therapeutic expertise; no matter the time (weekend phone calls) or the correspondence (fax and email), help was readily available. Our biggest strength was the ability to work cohesively as a group, even when assigned to independent projects. The team effort resonated despite distance or circumstance.
One situation in particular proved that our diverse yet harmonized expertise could resolve the most insurmountable problem.
Several of us had been tasked to spend several weeks assisting a project team in Trial Master File (TMF) reconciliation for a global phase III study: 200 sites, 900 patients, three years of study conduct that encompassed a plethora of amendments and ICF versions. All hands were called in to assist the backlog. The contract with the sponsor committed the last physical TMF folder to be shipped by 5 p.m. Friday; a frantic energy directed the effort. They were an important sponsor, which meant the deadline was nonnegotiable.
Our group had been assigned to reconcile three years of study Investigational New Drug (IND) safety reports with investigational site regulatory binders, to ensure consistency. We were each assigned 10 sites. My site folders thankfully were organized; my review was uneventful that week, so the deadline did not seem so ominous (for me) that final Friday morning. When I finished my final file review, I started to assist my colleagues. To our dismay, we discovered that two investigational site TMF sections were missing 10 investigator-signed safety reports. Of course, this discovery occurred at 1 p.m. on deadline Friday. So we sprang into action. We contacted the sites and luckily were able to reach each study coordinator (SC).
Somehow we convinced the SCs to fax the signed reports to the office, by 4 p.m., for TMF filing. Our happiness turned to concern when we realized the critical time lost during the process. It was now 3:15 p.m. Our return flight home was scheduled to depart at 5 p.m. If we left for the airport immediately, we would just make the required check-in time. That would force us to abandon resolution and compromise our deadline, which was never going to happen. Our unspoken decision to change our flights spurred our resolve. We were able to secure seats on the last flight out that evening and continue our important task. We received the missing IND safety reports around 4:15 p.m., finished the TMF reconciliation and delivered the final TMF folders to the FedEx drop-off at 5p.m. We met the sponsor deadline and the project successfully concluded. The project team’s unity during such a critical time was nothing short of amazing.
I left one year later to pursue a management position. It felt like the next logical step of career progression. The irony is that I struggled to find my way back to that organization ever since my departure. While I gained an invaluable skillset (managing employees) and am grateful for the experience, I never truly flourished as I did within the clinical environment. With that team, I felt like an important part of the entire process, not just an inconsequential element of a larger process. It was the best work experience I have ever had.
Six years later, I was recruited to work for that same organization on a specialized team in study startup. This team had expertise in site evaluation and pre-study assessment visits. Candidates were required to have strong therapeutic and study phase experience, and the ability to rapidly assimilate data due to the quick timeline in study start. The recruiter had done her homework in candidate consideration. When I was offered the position, I learned that four former colleagues also were being hired. It was exciting to think of our old team reuniting. For me, it meant I had come full circle with my career path, and was once again back where I belonged.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has served in a variety of clinical research roles including CRA, CRA trainer, CRA manager and clinical research writer. She works in relationship development/study startup in the CRO industry. Email email@example.com.
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