THE CLEAR VALUE OF CERTIFICATION
Adequately trained monitors/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 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.
“We value certification. It makes for stronger healthcare, it validates staff knowledge, and it’s attractive to sponsors.”
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 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.”
It doesn’t take a rocket scientist to see the value of certification, according to Brennan. She sees the positive impact of certification every day on the job at Northwell, where she has overseen clinical research support personnel, PIs, and other staff with mentoring and training since 2015. Her team includes more than 300 total research staff, with some 75 of them being Certified Clinical Research Coordinators (CCRCs) through ACRP. They are currently engaged in nearly 375 active clinical trials.
“We value certification,” Brennan says. Northwell reimburses staff if they make a passing score and considers it a sound investment in the present and the future. “It makes for stronger healthcare, it validates staff knowledge, and it’s attractive to sponsors,” she explains.
Brennan is a big advocate of certification across the board. “I’m a big believer that it’s not just about [the investigators]—you’ve got to have qualified coordinators. They are necessary to study success,” she says.
Valuing certification at the top of the organizational chart also has a positive impact on morale and broader company culture, Brennan says. “Coordinators feel empowered, and even new entrants are yearning to take the exam” because they want to be part of the movement toward higher quality and professionalization in the clinical trial workforce, she explains.