Demonstrating Clinical Trial Competencies

Erika Stevens, MA, FACRP, Principal, Recherche Transformation Rapide, LLC

Two pathways to learn JTF core skills

While demand for skilled clinical research professionals is at an all-time high, identifying candidates with the required skill sets is challenging.

“Clinical research is the only health profession that does not require a hands-on clinical practicum and assessment as part of the training,” says Erika Stevens, MA, FACRP, Principal, Recherche Transformation Rapide, LLC. “Over the last 10 years, there’s been a huge push for the clinical research industry to work toward professional competency and credentialing, with a vast influx of programmatic education. ACRP has been a leader in this field, offering a broad range of certifications and courses.”

Another important step forward was the core competency framework developed by the Joint Task Force for Clinical Trials Competency (JTF). This covers eight subject domains defining the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research. Each domain details the core competencies required at the basic, skilled, and expert levels.

“There are two main tracks to achieving the competencies outlined in the JTF framework,” explains Stevens. “One is continuing education through activities such as ACRP online learning modules, bootcamps, conferences, and certification. The second is through graduate education in clinical research. Both offer curricula geared toward meeting JTF competencies.”

“Our members rely on ACRP to continuously evolve the JTF framework so that it remains a go-to resource for creating roles and assessing performance for clinical research professionals,” said Susan Landis, Executive Director of ACRP. “At our ACRP 2023 conference, we’ll be discussing changes to make the assessment tool easier to use.”

Clinical Trial Competencies: Avenues for Meeting the JTF

Join Erika and Susan at ACRP 2023 [April 28 – May 1; Dallas, TX], where they will describe two leading practices for gaining knowledge, training, certification, education, and competency in clinical research, as outlined by the Joint Task Force. View complete schedule. 

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An interesting initiative is under way to add hands-on clinical experience as part of graduate education. “A promising option is to add clinical rotations to academic training – helping to support candidates wishing to enter the clinical research profession,” states Stevens. “This would offer an alternative to on-the-job training as a way to demonstrate competencies in clinical, administrative, and regulatory arenas. The MS in Clinical Research Management (CRM) within the School of Health Professions at Rutgers University offers this opportunity.”

“As the roles for clinical research professionals continue to expand, a clearly defined professional development path will help individuals demonstrate proficiency of the required competencies,” concludes Stevens. “This will support ongoing efforts within the clinical development enterprise to mitigate risk, produce high-quality data, and confirm regulatory compliance.”

Author: Jill Dawson