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Clinical Research Professional Competency

Focus Area: Capacity Building

Focus Area: Current Project

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. In 2018, the Joint Task Force for Clinical Trial Competency (JTF) defined competencies at Fundamental, Skilled and Advanced levels for all 47 competencies in the Framework. This “leveling” concept applies to recruitment, retention, and professional development of all clinical trial professionals and study team members. 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.

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

Deliverables:

Deliverables:

  • Adding competencies for clinical project management

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: Disseminated Framework through simultaneous publication in 5 peer reviewed journals including Clinical Researcher, Journal of Clinical Research Best Practices, and CenterWatch White Papers
  • October 2016: Convened Joint Task Force Core Competencies Workshop to discuss real world applications and potential future revisions of competency framework
  • November 2016: Initiated 2 new workgroups in the wake of the workshop:
    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: Launched first website of Joint Task Force for Clinical Trial Competency
  • September 2017: Launched Version 2.0 of Core Competency Framework
  • December 2017: Released Summary of Harmonized Core Competency Framework Version 2.0  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: Published Leveling of Joint Task Force Core Competencies for Clinical Research Professionals
  • December 2018: Released summary of Leveling the Harmonized Core Competency Framework Version 3.0 at MRCT Center Annual Meeting
  • February 2019: Launched new Joint Task Force for Clinical Trial Competency project website

Project Leadership: Barbara Bierer, Stephen Sonstein, Sarah White

Program Manager: Carmen Aldinger