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

Aim: This paper describes a simple education model for health service organisations engaging in clinical trials. Clinical trial coordinators (CTCs) are essential to operations of the clinical trial workforce; however, there is significant disparity in their skills and knowledge. The TrialHub upskilling pilot program is a novel, multimodal upskilling initiative which aims to develop an innovative clinical trial education framework to build consistent standards across the workforce, irrespective of site location and maturity. Method: The upskilling pilot program was implemented across 7 health service organisations with varying levels of clinical trial maturity. The program adopted a stepwise engagement approach, and incorporated elements including mentorship, in-house training program strategies, and ongoing professional development initiatives. This approach was guided by consultation at individual CTC level to health service organisation governance levels, enabling education programs driven by CTC needs and oversight strategies for upskilling standards at each site. Site activity engagement sessions were tracked to map the progress of upskilling element implementation, and informed on framework development. Results: Over a 30-month period (January 2022 to June 2024) site engagement tracking indicated diverse needs at each site, aligned with varying levels of site maturity and evolving upskilling priorities and focus throughout the pilot period. These insights underscore a requirement for tailoring upskilling elements and education initiatives to sites' specific circumstances and changing maturity during development. Subsequently an upskilling framework, informed by these program learnings, was established to guide future workforce development and growth needs. Conclusion: Although limited by a small sample size, this pilot program has demonstrated the potential of a tailored multi-modal upskilling approach to provide valuable professional learning experiences in clinical trial coordination, and support clinical trial site capability development. Clinical trial sites adoption of upskilling programs requires harmonisation and structured support through adaptive implementation, as described by the CTC upskilling framework. Upskilling CTCs in parallel with increasing clinical trial site capability is required if sites are to be adequately mature, and be able to meet the growing demands of Australian communities.