A successful CRA is diligent and has help
Monday, January 23, 2017
The Pulse on Study Conduct by Elizabeth Weeks-Rowe
What makes a Clinical Research Associate (CRA) successful? Medical training and clinical research experience provide basic fundamentals. Monitoring experience and therapeutic training provide role infrastructure. But experience alone does not distinguish the exceptional from the merely competent. Exceptional CRAs possess intrinsic qualities that define their performance. Some CRAs are effective communicators and can translate complicated medical jargon with ease. Other CRAs have superior data review skills that rival regulatory agency auditors. These qualities are difficult to quantify and are not universal.
Diligence is one shared trait among successful CRAs. The application of diligence to the core monitoring skill set will improve quality. Quality is what drives CRA proficiency and is the strongest assurance of credible data.
I once had the privilege of managing a new CRA 1 (let’s call her Susan) who embodied diligence in every action; this enabled her to overcome difficult obstacles and achieve great success as a CRA. She had laser sharp focus on career development. She imposed a learning opportunity on every experience, and inspired me to redirect my own career path.
Susan was a new transfer to the team of CRAs I managed, and had recently been signed off to independently monitor during a CRA assessment visit. Her assessment paperwork confirmed her monitoring competency despite challenging circumstances at the site. The only deficiencies noted were related to timing and prioritization. I contacted the line manager who assessed Susan to discuss the challenges identified during the visit. The manager confirmed Susan’s proficiency with the difficult protocol, and outlined the deviations she had discovered during the monitoring visit:
- The study drug infusion dose was based on a BSA calculation and there were discrepancies in documentation of the individual vs. collective vial dose between the source and CRFs.
- The site had not provided full source documentation of key inclusionary medical history criteria for several study patients; only a study coordinator (SC) generated source note clarified the appropriate medical history consistent with the inclusion criteria.
I asked the line manager about the challenges encountered during the visit. He confirmed that the noted protocol deviations did not sit well with the defensive SC, who questioned the accuracy of the findings and the CRA’s overall experience. Though the SC was understandably frustrated over CRA turnover at the site (Susan was the third CRA in six months), the criticism directed toward Susan was due to the SC’s error and subsequent deflection to mitigate said error. The assessor tried to allay Susan’s concern by explaining this, but it still caused Susan anxiety regarding her overall performance. The assessor also explained that while Susan’s review of critical data points and drug accountability was extremely thorough, her need (due to self-doubt) to re-verify information had prevented efficient data review. The SC’s incessant negativity during the monitoring visit had impacted Susan’s ability to prioritize successfully. There was a backlog of CRF data at the site and the noted obstacles prohibited overall data retrieval. Susan had only reviewed 20% of the outstanding CRF pages. The circumstances of the current monitoring visit had created a prohibitive site dynamic that would potentially impact future monitoring visits. Susan would require additional support to assure successful site management.
I thanked the line manager for his time and formulated a training plan targeting prioritization and efficient data review. My goal was to further develop Susan’s monitoring skills, which would, in turn, bolster her confidence and empower her to effectively deal with the SC.
I incorporated training elements into each of our one-on-one discussions. During one meeting we focused on drug accountability, study drug calculation, preparation and dispensation for oral, infusion and injection modalities. We reviewed best documentation practices for nursing staff administering the infusion and pharmacy staff maintaining subject-specific dispensation logs. We spent several hours discussing protocol questions gleaned from her monitoring visits, and reviewed a variety of monitoring visit prioritization strategies including site enrollment, quality/outstanding issues and specific study deadlines.
The most critical component to the educational process was Susan’s diligence in learning industry regulations. She spent her off hours reviewing clinical research textbooks and GCP guidelines. She began to trust her judgement instead of questioning her instincts. By the second monitoring visit, she was able to complete additional data review and improve the relationship with the SC. After the third monitoring visit, Susan was elated to inform me that she had retrieved 75% of the outstanding CRF data, and the SC had even thanked Susan for her assistance to the site.
Susan was given supportive strategies specific to her learning requirements—the same tools that facilitated my own CRA training. Though guidance may have influenced Susan’s conduct of the monitoring process, she was diligent in educating herself enough to execute the guidance to positive resolution. Her actions dictated the successful outcome.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and clinical research writer. She works in relationship development/study startup. Email email@example.com or tweet @ebwcra.
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