See All Projects

Clinical Research Professional Competency

Focus Area: Capacity Building

Clinical Research Professional Competency

The MRCT Center co-led an effort in 2013 to convene a group of diverse stakeholders to align and harmonize the many focused statements relating to core competencies for clinical research professionals into a single, high-level set of standards that could be adopted globally and serve as a framework for defining professional competency throughout the clinical research enterprise.

Since the Harmonized Core Competency Framework was released in 2014, institutions around the world have utilized and applied the Framework to develop job descriptions, training modules, and other resources. In 2016, the MRCT Center hosted a workshop that brought together representatives who had utilized the Framework in their own organizations.  Case studies highlighted real-world applications and participants provided feedback on potential revisions of the Framework.  The MRCT Center is now leading the Joint Task Force for Clinical Trials Competency to adapt and evolve the Framework to meet the needs of its stakeholders globally.

PI-Competence

Current Status: Active work groups

Impact: Clinical trial researchers and training organizations will be able to rely on a single set of harmonized competencies for training and qualification purposes.

Objectives:

  • Evolve the Framework to meet the needs of clinical researchers globally
  • Develop additional resources to aid in the professional development of clinical researchers

Key Milestones:

  • March 2013: Convened first meeting of stakeholder groups including industry, academia, clinical research organizations, clinical sites, and professional societies; the group was termed the Joint Task Force for Clinical Trial Competency
  • March 2014: Completed harmonization of clinical trial competencies within 8 specific domains
  • June 2014: Framework disseminated through simultaneous publication in 5 peer reviewed journals including Clinical Researcher, Journal of Clinical Research Best Practices, and CenterWatch White Papers
  • October 2016: Joint Task Force Core Competencies Workshop to discuss real world applications and potential future revisions of competency framework
  • November 2016: In the wake of the workshop, 2 new workgroups were initiated:
    The Revisions Workgroup, constituted to update the Harmonized Core Competency Framework based on suggestions from implementers and stakeholders;
    and The Levelling Workgroup, to define and stratify competencies at fundamental, skilled, and advanced levels.
  • May 2017: Joint Task Force for Clinical Trial Competency launched website
  • September 2017:  Joint Task Force for Clinical Trial Competency launched Version 2.0 of Core Competency Framework
  • December 2017: Summary of Harmonized Core Competency Framework Version 2.0 released at MRCT Center Annual Meeting
  • April 2018: Joint Task Force for Clinical Trial Competency was one of three finalists for the ACRP Innovation in Workforce Development Award
  • October 2018: Leveling of Joint Task Force Core Competencies for Clinical Research Professionals published

Project Manager: Carmen Aldinger