Standards Key to Preparing CRCs for Evolving Trials Landscape

Jim Kremidas, ACRP Executive Director

Jim Kremidas, ACRP Executive Director

While jobs are still plentiful today, clinical researcher coordinators (CRCs) must think about tomorrow, when the openings may begin to decrease even as the work becomes more complicated. With such innovations as remote monitoring and risk-based monitoring in place already or on the horizon, most experts agree that new demands on professionals will require new skills from those who expect to thrive in the future.

Key to gaining the necessary skills will be active programs that promote the development of the “grassroots” professionals—those who directly conduct clinical trials and who will be important drivers for implementing new ways to improve clinical trial quality and efficiencies, says Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). The Association’s goals include championing new ways to fill the job pipeline with well-trained CRCs.

“Employers have been complaining that university-prepared students are not entering the workforce with the ability to do the tasks required in their roles,” Kremidas said. He’ll share these and other ideas at the Clinical Trials & IoT (Internet of Things) Forum in Cambridge, Mass., November 7–8 (discount code for ACRP Members below).

ACRP advocates the creation of a hierarchy of competencies focused on performance, not longevity, in order to improve the quality of tomorrow’s workforce, Kremidas said. Specifically, competency should be based on a clearly defined set of standards demonstrating knowledge and skills.

CRCs know their work roles will changes significantly in the next few years. In an ACRP job survey with more than 1,000 responses, CRCs said they expected their roles to evolve in several ways, including:

  • Technology will outpace regulations
  • Corrective and preventive action (CAPA) and risk evaluation mitigation plans will require better understanding of data management principles
  • Transition from paper to electronic formats for everything
  • Clinical research associates (CRAs) will become site managers

Finally, CRCs believe that with this increasing complexity will come an even greater need for trained staff.

“We need to lay the foundation for a new wave of CRCs and CRAs who will be able to meet and surpass future challenges,” Kremidas said.

Common sense suggests these kind of clear standards will improve the workforce, Kremidas added. However, a review of U.S. Food and Drug Administration inspection findings in 2015 offers some harder evidence that core competencies need to be more clearly defined and enforced. The most common clinical investigator deficiencies spotlighted in the review include:

  • Failure to follow the investigation plan and/or regulations
  • Protocol deviations
  • Inadequate recordkeeping
  • Inadequate accountability for the investigational product
  • Inadequate communication with the institutional review board
  • Inadequate subject protection (failure to report adverse events and informed consent issues)

To be effective and recognized in industry, competencies should be measured and assessed by a reputable organization with the credibility to make such pronouncements, Kremidas said. Leading that charge has been the Joint Task Force for Clinical Trial Competency. Supported by MAGI, DIA, and ACRP, it is organized under the sponsorship of the Multi-Regional Clinical Trials Center at Harvard University and ACRES (Alliance for Clinical Research Excellence and Safety).

Kremidas will discuss the importance of workforce certification at the Clinical Trials & IoT (Internet of Things) Forum in Cambridge, Mass., November 7–8.

ACRP Members can receive 25% off all conference passes using discount code ACRP25.