Clinical Researcher—February 2025 (Volume 39, Issue 1)

ON THE JOB

Elizabeth Weeks-Rowe, LVN, CCRA

 

 

 

“Trial by fire.” “Test of mettle.” “Proving ground.” These are among the common phrases that describe the collective origin story of many clinical researchers and their not-so-gentle assimilation to this industry. Most stories have a similar inception; however, each storyline is unique as it unfolds in its own incredible fashion.

Whatever the circumstance, these individuals were thrown into clinical research without foreknowledge of the research landscape or its governing regulations. They strove to understand a superabundance of new information and develop new skills without any formal training. The results were all too often a rougher-than-necessary career path for those willing to endure the pressure of learning a new industry and a new role, which is sometimes the unfortunate plight of those brand new to this enterprise.

Most recall their “trial by fire” assimilation to clinical research as grueling, but with positive and humorous elements. Knowledge borne of error is substantial and not likely to be repeated due to profundity. That trial and error helped develop their self-reliance. On-the-spot problem-solving situations forced them to raise their standards for critical thinking in search of resolutions. These are positive elements.

They also remember a learning environment framed by stress and lacking, at times, in structure and coherency. They sometimes felt lost and unsupported in grueling circumstances.

They remember the humor as they attempted tasks for which they were so ill prepared. Using colored ink on a case report form page or white out on a 1572, answering queries with questions, forgetting passwords on the plethora of platforms they were saddled with, and feigning bravado during patient visits as they secretly felt like they “did not know what they were doing.”

On the Lighter Side

I can attest to the humorous side that hid among all the rest of such challenges. As a new study coordinator completing tasks far beyond my comfort level, the comedic elements varied according to the task.

Staining the walls of my principal investigator’s private bathroom purple when attempting to “stain” sputum samples for a pneumonia study.

Leaving the room to catch my breath and build my resolve when asked to help a study patient obtain a sputum sample.

Being asked to track patients “lost to follow up” and wondering why they were lost in the first place.

Laughing in the face of the seemingly impossible creates resolve. That resolve helps the impossible become habitual once tried and understood. Once habitual, the accompanying perspective becomes the lens allowing us to view obstacles as opportunities. However, finding oneself mired in it all without being prepared can affect peace of mind, create self-doubt, and impact quality of life at work and at home.

In Search of a Good Start

My origin story is not unique. I too was faced with learning a new industry and a new role. I was overwhelmed, and barely made it through those first three months as a new study coordinator. The training was piecemeal, lacking in structure, and only provided as time permitted. There was no curriculum or process. There were no reference materials to lend clarity and no job description to set expectations.

A safe, effective learning environment is key for clinical researchers faced with a new industry and a new role. It must have the substance and pacing to promote the confidence required for momentum. Once the fundamentals are introduced, the roles and responsibilities will be made clearer. This is crucial for patient safety and data quality.

No matter the size or infrastructure of the investigational site, there are essential training tools that will guide new clinical researchers through their dual learning paradigm:

• There should be an introductory clinical research manual or course to facilitate understanding of the clinical trials landscape. This should be the first training element. It would optimally include a high-level overview of research regulations/guidelines. The overarching goal is to provide the essential foundation from which the individual can build understanding and develop additional skills for their position.
• There should be a clear job description and standard operating procedures (SOPs)/guidelines for the research process. This is especially beneficial for those taking over a position without a transition from an individual being replaced. All too often, study coordinators take over from an absent predecessor and there is no direction on where to resume or what the priorities are, and this results in studies/patients/critical follow-up falling through the proverbial cracks.
• There should be more than one option for learning. Some individuals learn best from repetitive review, while some must have a task demonstrated before completing it, and then have the option to practice that task before independent conduct. All new learners benefit from a combination of theory and execution. Some institutions are so heavy on SOP review that they fail to include the practice environment in their new employee training, which renders the training virtually useless. The most effective onboarding programs have elements of each, and require new employees to review, observe, practice and be evaluated for competency before independent conduct.
• There should be a shadowing period. A new study coordinator should be required to shadow experienced staff as they complete research tasks until a comfort level is reached. Some examples include observing the investigator consenting a study patient, observing lab staff draw blood and process samples, and watching videos of staff giving injections and preparing medication. Exposure to all roles that form and contribute to the study lends perspective and builds knowledge, and from these seeds expertise grows.

A safe, structured learning environment prioritizes new clinical researchers obtaining a preliminary understanding of the clinical trials landscape and the chance to practice their role before independent conduct.

Elizabeth Weeks-Rowe, LVN, CCRA, has broad experience as a clinical research consultant, trainer, site evaluation and selection expert, content creator, and conference presenter. She is the author of The CRA’s Guide to Monitoring Research. Based in California, she last wrote for Clinical Researcher in April 2024 about “The Art of Investigational Site Relationships with Sponsors/CROs.”