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Clinical Research Professional Competency

Focus Area: Training

Clinical Research Professional Competency

The MRCT Center co-led an effort to convene a group of diverse stakeholders for this project. The group agreed to work toward aligning and harmonizing the many focused statements relating to core competencies for clinical research professionals into a single, high-level set of standards which 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 a diverse group of stakeholders who have utilized the Framework in their own organizations.  Case studies were presented to highlight real-world applications, to gather feedback on potential revisions of the Framework, and to develop future objectives. The MRCT Center is now co-leading the Joint Task Force for Clinical Trials Competency as the group adapts and evolves 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:

  • Identify training materials for mapping and harmonization of competencies
  • Harmonize and draft framework for domains and competencies
  • 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 – this group was named the Joint Task Force for Clinical Trial Competency
  • March 2014 – Completed harmonization of clinical trial competencies within specific domains
  • Spring 2014 – Work 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, whose objective is to update the Harmonized Core Competency Framework based on suggestions from implementers and stakeholders;
    and The Levelling Workgroup, which will develop additional resources for workforce development.
  • 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 2017Summary of Harmonized Core Competency Framework Version 2.0 released at MRCT Center Annual Meeting

Program Manager: Carmen Aldinger