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The benefits of wearing many hats in clinical research

Monday, March 6, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

Anyone seeking a consistent and predictable work environment would likely not pursue a career in clinical research. The compassionate person who wants to impact humanity and cure disease, an intellectual who desires an important role in the drug development process, a person who longs to travel and work outside the 9-5 corporate structure—these are the people who pursue a career in clinical research. Once that career starts, two exultant feet hit the ground running, pausing only to breathe, learn and feel grateful for the opportunity.

Clinical researchers in academia and mainstream research are often required to wear many hats within their designated positions. Adaptability is key to survive and succeed. Consider these potential scenarios. The Clinical Research Associate (CRA) may need to serve as an additional data manager during an interim data analysis. The Principal Investigator (PI) may have to draw/process blood specimens for several patient screening visits if the study nurse is ill. A CRA manager may have to co-monitor (with the CRA they manage) a high-enrolling site for several months due to a backlog of Case Report Form (CRF) data/queries.

We all have had to assume responsibilities outside the parameters of our job description, which may even include a temporary transfer of position or department should the organizational need warrant (e.g. employee medical absence that leaves a position to be filled or low departmental workload that requires a transfer for the employee to stay billable). It is at the discretion of the manager whether the employee is asked or instructed to make this change, and this can greatly impact the employee’s perception of the directive. While the transfer is usually temporary (and the employee lulled with a fixed deadline), circumstance can extend the deadline to seeming permanence. While the change solves the larger staffing issue for management, it may negatively influence the peace of mind of the employee forced into the change.

The CRA asked to temporarily work in data management anticipates the stifling monotony of an office job, which he avoided with his exciting, engaging role as a traveling CRA.

The CRA manager tasked to help her CRA co-monitor anticipates that the additional monitoring will virtually triple her existing workload, add insurmountable stress and prevent her from adequately supporting her CRAs.

The PI required to draw/process blood specimens for patient screening visits to cover for his ill staff member anticipates frustration from his patients and colleagues due to his unavailability, and a negative impact on patient retention due to canceling/rearranging patient visits.

These are the anticipated negative outcomes for each individual thrust into this unexpected circumstance. Understandable, but eminently preventable with the right plan and the right mindset to combat factors influencing the negativity. If a paradigm change is accompanied by a strategy to mitigate collateral chaos, transitional anxiety transforms to transitional acceptance. Transitional acceptance influences a positive mindset that makes for enduring change.

Alternative outcomes are wrought by internal commitment/acceptance.

The CRA “loaned” to data management commits to role proficiency. He re-reviews the eCRF guidelines to best prepare for the transition. He observes a senior data manager expertly resolve queries and interact with once-frustrated investigative site staff. He learns accurate query creation and resolution with source data review. He is able to provide his sites with targeted guidance regarding query fields, adverse event and concomitant medication page population. This ultimately lowers the overall query rate at his sites, strengthening his site relationships. He feels grateful for the skills acquired.

The CRA manager decides to delegate a portion of team management and administrative duties to several trusted Senior CRAs. This had the dual advantage of workload management for the CRA manager and CRA exposure to a management role she may be considering in the future. The strongest byproduct of this delegation is increased trust and communication between senior staff and management. The CRA manager is reminded of how much she enjoyed monitoring and site engagement. It also increases her empathy and understanding for her traveling team if they occasionally miss a deadline due to a high workload.

The PI begins to seriously consider the benefits of hiring a backup study nurse to cover for absent staff. The PI also realizes that his full oversight of the study is lacking due to his busy private practice. He decides to dedicate one full day a week to research activities, such as study visit conduct, staff meetings/training and chart/SAE results review. His subsequent involvement strengthens staff relations and overall study conduct at his site. His study nurse is relieved that backup staff can cover the study patient visits in the event of her unexpected absence.


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 ebwcra@yahoo.com or tweet @ebwcra.

This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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