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Joint Task Force for Clinical Trial 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. In 2019, the MRCT Center led a workgroup that updated the Framework to include competencies related to clinical project management.

The MRCT Center will continue to lead the Joint Task Force for Clinical Trials Competency to adapt and evolve the Framework to meet the needs of its stakeholders globally. To date, the Framework has been translated into Spanish and Japanese.

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:

Upcoming:

  • Self-Assessment Survey of Clinical Research Competency

Key Milestones:

Project Leadership:

  • Barbara E. Bierer, MD, Faculty Director, MRCT Center
  • Stephen Sonstein, PhD. Senior Advisor, MRCT Center
  • Sarah White, MPH. Executive Director, MRCT Center

Program Manager: Carmen Aldinger, PhD, MPH, PMP