Clinical Trial Practitioners Extol Virtues of Training, Certification

Maggie Potrikus, BSN, CCRC, MBA, Quality Assurance and Compliance Manager, Concentrics Research

Adequately trained monitors/clinical research associates (CRAs) “will be prepared for just about anything” an increasingly complex clinical trial landscape is liable to throw at them, says Maggie Potrikus, BSN, CCRC, MBA, a quality assurance and compliance manager with Concentrics Research, a contract research organization (CRO), and former contracted CRA to Roche Diagnostics. On the other hand, “a lack of training means you won’t get the big picture and you’ll miss important things as a CRA,” she adds.

Certification will be critical in the future,” says Potrikus, who is certified as a clinical research coordinator through ACRP. Already important today, it is only going to become more so, as the demands of clinical trials and the evolving workforce fundamentally change how trials are conducted, she notes.

For example, Potrikus sees a new “entrepreneurial spirit” entering the CRA workforce, meaning more CRAs will operate independently or work for multiple CROs. In that case, unchecked variance in performance standards will threaten overall quality. “I think ACRP can help fill that void with its [training for CRAs],” she adds.

Training isn’t always cheap, and the benefits aren’t immediate, Potrikus acknowledged. However, failure to devote enough time and attention to training and certification is nothing less that “short-sighted,” she says.

“We need to take a step back and look at how we are conducting training as an industry,” says Jaylene Weigel, director of clinical research operations at Children’s Mercy Hospital at St Luke’s School of Nursing in Kansas City. She’s a big advocate of mentors and mentoring programs. “Mentors are especially critical during the first six to nine months on the job,” Weigel says.

A revamped training approach is critical if the clinical trial industry wants to become a driver of change rather than a reactor, says Christina Brennan, MD, MBA, vice president for clinical research at Northwell Health. “It’s hard enough to get any change in clinical research,” she notes, “and it’s going to happen even more slowly if we just train our CRAs to be what we’ve always thought them to be.”

Author: Michael Causey