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State of the Industry: Established Competencies Will Drive Better Practices in Clinical Research

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This guest blog post by Michael Causey comes from our partner Association of Clinical Research Professionals (ACRP).

While the demands on clinical research professionals to deliver high-quality study data more quickly and efficiently have arguably never been greater, industry continues to shy away from adapting technologies and new best practices that could help lighten the load, experts say.

“There is a lot of work to be done to manage the disparate pieces” of the clinical trial business, says Ken Getz, an associate professor and director of the Tufts Center for the Study of Drug Development at Tufts University. “There are tremendous inefficiencies and fractured collaborative efforts” slowing real forward progress, he adds.

Today’s clinical research industry needs to better prepare for tomorrow with targeted education and an embrace of technology and other new competencies, adds Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP).

One solution: The adoption of agreed-upon core competencies for different clinical research team roles and the overall professionalization of the industry. “It is important that we acknowledge that a focus on competency helps to drive better practices,” Getz says. “For the longest time, we’ve looked at tenure as the primary criteria to determine whether an individual will perform successfully professionally, and we’ve learned time and time again that it’s much more about broad competency.”

“We need a baseline of competency,” adds Kremidas. Experience in the form of tenure can be helpful, yet it alone does not prove a person is good at his or her job.

ACRP’s data show that, whether looking at a clinical research associate (monitor), clinical research coordinator, or some other industry role, the failure rate on competency exams is about the same for a professional with two years of experience compared to someone with five, 10, or even 30, Kremidas says. “What that says is tenure is not a solution,” he explains. Instead, industry needs to define core competencies and improve training for each role, and to give existing workers and prospective new entrants a clear path to learn and demonstrate their new competencies.

“Reducing the variance in training is likely to reduce performance errors, too,” Kremidas says.

Getting this right will provide a brighter career path even as it helps to ease the current workforce shortage of monitors. Up to now, industry has been “fuzzy” in how it defines roles and competencies, Kremidas notes.


The Association of Clinical Research Professionals (ACRP) is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings.  ACRP's on-demand eLearning courses equips your staff with not only an understanding of the core concepts of Good Clinical Practice (GCP) but how to put those concepts into action through a series of ongoing "knowledge checks" and real-world scenarios likely to be encountered during a clinical trial.  The courses provide formal training on the International Conference on Harmonization (ICH) Guidelines for GCP, the globally recognized standard for the conduct of clinical trials, for clinical research professionals.  Developed by leading Subject Matter Experts, the ACRP GCP training library is a collection of titles designed to train your staff on the most current standards of care.  For more information about the Good Clinical Practices training library, click here.