A framework for upskilling the clinical trial site: Learnings from a clinical trial coordinator workforce capability...

Area of Science:

• Health Services Research
• Clinical Trial Management
• Workforce Development

Background:

• Clinical trial coordinators (CTCs) are vital to clinical trial operations.
• Significant disparities exist in CTC skills and knowledge across health service organisations.
• A need for standardized education and upskilling initiatives for CTCs is evident.

Purpose of the Study:

• To describe a novel, multimodal upskilling pilot program for health service organisations.
• To develop an innovative clinical trial education framework to standardize workforce skills.
• To address the disparity in skills and knowledge among clinical trial coordinators.

Main Methods:

• Implemented a stepwise engagement approach across 7 health service organisations.
• Incorporated mentorship, in-house training, and professional development initiatives.
• Guided by consultations from individual CTCs to organizational governance levels.

Main Results:

• Over 30 months, diverse site needs were identified, varying with site maturity.
• Tailoring upskilling elements to specific site circumstances and maturity was crucial.
• An upskilling framework was established based on program learnings.

Conclusions:

• The pilot demonstrated the potential of a tailored, multimodal upskilling approach for CTCs.
• Harmonization and structured support are necessary for clinical trial site adoption of upskilling programs.
• Upskilling CTCs is essential for developing clinical trial site capability to meet community demands.