Clinical Researcher—June 2020 (Volume 34, Issue 6)

SITE STRATEGIES

Elizabeth Weeks-Rowe, LVN, CCRA

 

Learning to become a clinical research coordinator (CRC) can be an exhilarating and overwhelming process. Whether you are employed at a small research site or a large academic institution, the expectations are the same: to gain a foundational understanding of clinical research and new position responsibilities. Allowing sufficient time for this assimilation process to run its course is critical if performance gains are to follow.

The probationary employment period for a new CRC is a test of diligence, endurance, and resourcefulness. It is an emotional roller coaster of anxiety/accomplishment. A day filled with understanding confirms this life-changing career choice; a day fraught with misunderstanding renders uncertainty over it. The probationary learning period is critical for developing the behaviors to successfully conduct this position: critical thinking, comfort, and confidence. Organizational investment in an appropriate employee onboarding/developmental process promotes a confident, sustainable workforce.

Different, But Not Equal, Paths to Follow

There are several training methods for the CRC role, and your institutional model, policies, and resources generally determine the method used. Most sites/institutions employ a methodical process of blended learning or lesson/practice—new CRCs initially attend training workshops (either sponsored by the institution or outsourced to a training vendor) to learn the elemental functions of their role. They also complete online Good Clinical Practice (GCP) training, Human Subject Protection (HSP) training, clinical research history, regulations and guidelines training, and site-specific research ethics/institutional review board policy training.

During, or soon after the theoretical portion, comes the execution of the learning process. This includes observation/sign-off on the fundamental responsibilities of the position. The new CRC would observe an experienced colleague conducting tasks such as consenting patients, completing study visits/procedures, data review/extrapolation, regulatory submissions, etc., and then the CRC is likewise observed completing the task until confirmation of independent conduct.

The experienced colleague serves as a mentor to supplement/support the learning process. The onboarding process can take from six weeks to three months, and generally includes a mixture of theoretical and executional elements noted above, with the exact contents being dependent on the individual learning process and the environment in which the training is conducted.

An alternative and less optimal learning process is the “trial by fire” learning process. This process does not allow a controlled learning environment where all candidates can flourish. It forces the new hire to complete his or her own haphazard, inconsistent onboarding since a formal training/mentoring process does not exist. This puts a large burden on study monitors, with trial progress contingent upon the CRC’s performance of duties, by forcing them to spend more time training and less attention to their workload. This impacts productivity and unnecessarily strains the CRC-monitor relationship.

Trial by fire training widens the disparity between angst and confidence, whereas a structured training helps transform anxiety to accomplishment with each lesson learned. It introduces error into the learning process with the lack of direction, and it increases attrition/turnover of less resilient (but no less competent) employees who are unable to flourish in an ineffective training environment.

The approach of treating “error as a learning opportunity” is valid, but only at the end of a study or process, to ensure the next endeavor does not suffer the same mistakes. When new hires are given this—and only this—approach as the organization’s training method, it can impact fledgling confidence, not to mention create preventable quality/data issues.

Benefits from Following the Best Path

There is no standardized blueprint for new CRC onboarding/development. Each site should include institutional best practices, available resources, and strong employees to facilitate the process.

Monitors observe and CRCs experience the results of organizational investment in employee training during monitoring visits in terms of the quality of data collected/reported, GCP-compliant safety levels achieved, recruitment and consenting processes successfully handled, and quality trials efficiently conducted. Indeed, during a recent site evaluation visit teleconference with a new CRC, I observed firsthand the confidence, transparency, and resourcefulness that is possible in an employee whose organization has made an investment in their proper training and support.

The process for such teleconference evaluation visits is identical to the onsite evaluation visit process, and includes protocol and recruitment discussions with the investigator and key staff; confirmation of regulatory activities, site training, research processes, staff experience, and workload; and assessment of the suitability of site staff, equipment, and facilities for study conduct. The confirmation letter for the visit includes an agenda of discussion points, timeframes, and key staff required for the discussions. It is best practice to include all relevant details required for preparation, as it must address a variety of experience levels.

The primary CRC with whom I was in touch for the confirmed evaluation teleconference worked for a large academic health center. She informed me that she would have an experienced colleague attend the teleconference with her, as she was new and wanted to make sure I had the correct information. Her supervisor worked in the same office space and would be available by instant message to answer additional questions I had. She has also arranged for the research pharmacist to call in and provide information on study drug shipment/storage and preparation.

During the teleconference, she informed me that her training process included online GCP and CRC training, as well as an observation and sign-off process. She added that since this was her first independent visit, she and her supervisor had worked to ensure critical staff and information were available to facilitate the teleconference. She was organized, transparent, and earnest in her efficiency and presentation. Her confidence level for the study at hand was the welcome result of a structured training process that benefitted the employee, institution, and sponsor.

Elizabeth Weeks-Rowe, LVN, CCRA, (elizabethwrowe@gmail.com) is a former CRC who now works in site selection and education in the contract research organization industry. She last wrote for Clinical Researcher in December 2019’s “An Overview of Oversight.”