ACRP develops framework in response to 'significant' CRA shortage

By Melissa Fassbender

- Last updated on GMT

ACRP developed CRA framework open for comment

Related tags Clinical research

The Association of Clinical Research Professionals (ACRP) has published a new guidance addressing the standardization of competence required for clinical trial monitors.

The new Core Competency Framework for Clinical Research Associates (CRAs) has been posted​ for public review and comment until March 5, 2017.

To learn more about the framework, Outsourcing-Pharma.com talked with Terri Hinkley, ACRP’s Workforce Innovation Officer.

Why did ACRP develop the framework?

Terri Hinkley
Terri Hinkley

ACRP embarked on the development of the monitoring competencies in the fall of 2015 in response to the significant shortage of experienced CRAs in the industry.

The Joint Task Force for Clinical Trial Competency had published a competency framework for clinical research professionals in 2014 and ACRP felt the JTF framework was an appropriate starting place to develop monitoring specific competencies.

How was it developed?

ACRP began this initiative by forming a Task Force of 12 individuals with a broad representation of the clinical research industry. The Task Force reviewed the JTF competencies as well as other publicly available or Task Force member company competency frameworks. They then developed the monitoring competencies required in each domain and ‘levelled’ the competencies based on experience from entry level through to the expert or CRA lead role.

ACRP then formed a Steering Committee, which is made up of 10 senior level executives from several sponsor and CRO organizations. The Steering Committee is responsible for reviewing and approving the competencies drafted by the Task Force and both groups are further tasked with promoting the dissemination and adoption of the monitoring competencies.

What are some of its key components?

The key components of the competencies are the domain areas, the competency statements and the leveling across experience levels. The competencies were built to address on-site monitoring as well as some of the aspects of remote/central monitoring.

Currently, what are some of the main reasons there has been a shortage of CRAs in the workforce?

In the absence of competencies, the industry has required that CRAs have a minimum of two years monitoring experience to be ‘billable’ on study activities. As the industry grows and matures, this requirement has meant there is no clear path into a CRA role at the beginner level.

As a result, there is no pipeline of talent being developed as attrition occurs within the existing CRA population. The CRA role is a challenging one that requires a significant amount of travel and many CRAs move laterally or upwards out of monitoring roles to reduce the amount of travel required.

What are some of the initiatives working to address this?

Many CROs have developed internal training programs to bring in new CRAs but in the absence of a set of standards by which they can be evaluated, there has been a slow uptake of these new CRAs. The competency framework is intended to provide a means by which competency can be assessed and to provide some agreement within the industry on what those competencies are. ACRP, as a non-profit organization, is well positioned to lead this initiative given our neutral, non-biased perspective.

Further, the Consortium of Academic Programs in Clinical Research (CoAPCR) is a group of educational institutions that are working to get academic programs in clinical research accredited. Their standards for accreditation are also based on the Joint Task Force competency framework, which ensures that individuals enrolled in accredited clinical research programs are also being educated to the competencies identified and developed for all clinical research professionals. ACRP is also a supporting member of the CoAPCR.

(Feature image: iStock/3D_generator )

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