The CRA life: Dedication, passion, adaptability
To achieve a level of expertise in a clinical research role, dedication that exceeds standard performance is required. It requires a passion for innovation, the willingness to work outside your position or comfort zone, and the ability to adapt what you’ve learned to align with regulatory standards.
I repeatedly witness this level of dedication by clinical research professionals. For example: the investigator (on my flight) with his tray table close to buckling under the load of medical journals, to the chagrin of the harried flight attendant who has to remind him repeatedly to raise it for landing. Or the CRA with study materials spread across the sitting area of the gate, so engrossed in reading that he nearly misses his flight. Their commonality: dedication to the research craft is not limited to 9-5 business hours, nor is it confined to brick and mortar structures. It occurs after hours, at home, in transport, at rest; a near obsession that drives every decision to treat, audit, discover and resolve.
Discovery propels us to continually learn lest we grow stagnant. Therefore, an ambitious individual who has assimilated the relevant knowledge of one specialty will logically progress to the next level to learn new information. The desire to increase a knowledge base is never sated; however, the downside is that the change is often accompanied by a different set of requirements that can render the expert a novice, tempering enthusiasm with stress.
I experienced the same internal shift, the feeling that the skill set was mastered and I was ready for the next challenge, several years after I was promoted to Senior CRA. I had conducted each monitoring visit type, and had trained and mentored CRAs across all position levels. Therefore, when a former supervisor approached me about a CRA management position at her company, I jumped at the opportunity.
How to transition back to a clinical operations monitoring role after a prolonged absence.
- Read and familiarize with ICH E 6, and 21CFR Parts 11, 50, 54 56, 312, 314.
- Memorize your specific job description and every organizational SOP/WPD that dictates your role, and monitoring visit conduct.
- Review FDA guidances on Risk-based monitoring, Investigator responsibilities
- Read the question/answer document for the study to which you are assigned.
- Schedule a meeting with the study team manager or project manager to obtain
- additional insight to study process, challenges, deadlines
- Call each investigational site to which you have been assigned, introduce yourself as the new monitor and speak to the study coordinator about the trial, and status quo.
I worked as a CRA manager for 3 years, and learned to manage a CRA team through training, resourcing and career development. The leadership skills I acquired from the position were invaluable, but the entire experience reinforced that I was forever a creature of clin ops. I yearned for the frenetic pace of a study.
To my good fortune, a position in study start up opened at my former company. They had recently formed a pilot team of CRAs dedicated to investigator assessment. The CRAs had been selected for their expertise in training, diversity of therapeutic familiarity and SWAT monitoring ability. The premise of the team was rapid investigator selection, and the experience of the collective team would facilitate that process.
Though I had not conducted a pre-study visit in 4 years, I knew I was qualified for the position. Fortunately, my former employer shared this opinion and offered me a position on the team. They did not have any concerns with my absence from the monitoring role. And I did not anticipate any difficulty returning to such an ingrained clinical process. Monitoring was like riding a bike, I reasoned to myself. The skill set returned as soon as you sprang from the proverbial kick stand. Or so I thought…
As the date of my first pre study visit approached, I realized I had I underestimated my nervousness about visit conduct. This was not due to a question of ability, but unreasonable personal expectations. Having a type A, perfectionist personality, usually beneficial to a monitoring role, had become an Achilles heel in returning to the role. I had always conducted monitoring visits with strict adherence to protocol and GCP compliance. This assured a strong level of confidence with investigational site interaction. It was imperative that my return to this dynamic was as competent and structured, so I over prepared for the pre-study visit, and put a lot of unnecessary pressure on myself. I repeatedly reviewed the organizational SOP for site assessment conduct. I committed the protocol and product package insert to memory, as if it were a complex oncology trial instead of a simple trial design for an over-the-counter product (which it was). I googled the investigator for a specific experience to reference, and confirmed investigator status with the FDA deparment and audit listing on the FDA website. Lastly, I created a 20 page checklist to ensure each topic was covered and no piece of equipment unconfirmed. I felt I had to master this meeting, for my own peace of mind, and to confirm that my company had made the right decision to rehire me.
As it happens, the pre-study visit was completed uneventfully and was rather anticlimactic in the aftermath of such intense preparation. Though my diligence may have been overkill, it allowed me to present the study information in a comprehensive manner. The irony was that the study coordinator informed me that I made it appear so easy. The effort wrought a successful return to clinical, though I stressed myself out in the process.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in clinical research roles including CRA, CRA trainer, CRA manager and clinical research writer. She has authored the novella Clinical Research Trials and Triumphs. Email email@example.com