ACRP members and associates are working to create a “critical mass” of awareness and activity to address root cause problems threatening the future of high-quality clinical research, ACRP Executive Director Jim Kremidas told attendees at the 8th Annual Avoca Global Summit this week in Boston.
“We’re leading the charge together because the stakes are too high to sit back and do nothing,” Kremidas said. He outlined a number of initiatives ACRP is undertaking, as driver and partner, to confront such stubborn clinical trial trends as the facts that:
- People are unaware of clinical research as a career option.
- There is no clear understanding of what makes a good hire for entry-level roles in terms of competency.
- The site industry is fragmented, resulting in different types of role and responsibility definitions that don’t always translate from one place to the next.
- Many sites cannot afford to develop their own in-house training.
- Many individuals fail to see the value of certification in and validation of their research roles.
- Sponsors and regulators don’t mandate certification.
The ongoing problems created by these trends are clear, Kremidas said. At present, the industry is suffering from an alarming shortage of entry-level candidates. Compounding the problem, ineffective hiring and onboarding practices contribute to high levels of attrition, high levels of employee dissatisfaction, and low levels of performance.
“One of the unfortunate end results is a dearth of validated, competent professionals” on the horizon, Kremidas said. Unchecked, the problem will only grow more acute, he added.
Kremidas challenged the industry to do better. “We are identifying these problems, and now we are rolling up our sleeves to begin to solve them together,” he said. He called on other industry leaders to explore several active initiatives and helpful publications, including:
- The Partners in Workforce Advancement (PWA) campaign to introduce clinical trials as a career to a new wave of incoming professionals.
- White papers on Competency-Based Hiring for Entry-Level for Clinical Research Coordinators (CRCs) and Role-Specific Competency Guidelines for CRCs and Monitors.
- Work in progress by the Workforce Innovation Steering Committee to develop Principal Investigator Competence Standards.
ACRP and partners are also exploring the development of skills- and competency-based training and assessment tools for standardized, quality-focused onboarding of entry-level roles with a “micro-learning” focus. Plans are also under way to collect and disseminate data showing the positive impacts of certification on quality and other productivity measures in clinical trials.
“Common sense says better trained professionals are more motivated, higher level performers,” Kremidas said. “Turns out, there’s a growing collection of data and anecdotal evidence to support the idea, too.”
Author: Michael Causey