Background Clinical research coordinators play a crucial role in ensuring the scientific rigor, regulatory compliance, and operational integrity of clinical trials. However, in Africa, they often lack access to structured, competency-based training, especially in operational, regulatory, and trial management domains. This study evaluated the effectiveness of a comprehensive training intervention designed to standardize and enhance core competencies of clinical trial coordinators.

Methods We conducted a prospective pre-post interventional study among cohorts of clinical research professionals completing a 10-week, internationally-accredited, Moodle-based clinical trial operations training program aligned with the Joint Task Force Core Competency Framework, covering 10 lessons and 25 domains. Self-reported competence was evaluated at baseline and post-training. Data analyses included paired t-tests for aggregate scores, McNemar’s exact test for domain-level proportions, multivariable logistic regression for predictors of improvement, and Cohen’s d for effect size.

Results Among the 166 participants enrolled from 19 African countries and completed the pre-training survey, 152 who completed the program and post-training survey were included. The training significantly increased the mean aggregate competence from 12.24±7.85 (out of a maximum of 25) to 23.35±2.73 (mean difference: 11.11; 95% CI 9.86-12.36; p<0.001; Cohen’s d=1.41). Score variance decreased, with the median score increasing from 12.0 (IQR: 6.0-19.0) to 24.5 (IQR: 23.0-25.0). All 25 domains improved (p<0.001), with the largest gains in complex, low-baseline domains: managing external partners (+59.2%), project management (+58.6%), financial management (+55.3%), and trial close-out (+57.2%). (+57.2%). Ethical principles and informed consent that had high baseline competence reached near-universal levels at 99.3% and 98.7%, respectively. No differences were observed by country or gender (p>0.05).

Conclusion Structured, competency-based training strengthens clinical trial coordinators’ capabilities, particularly in technical and administrative domains that are often overlooked. Accredited, framework-aligned clinical trial training programs promote consistent trial quality, strengthen research capacity, and sustain excellence in clinical trial delivery.

WHAT IS ALREADY KNOWN ON THIS TOPIC

- Clinical research coordinators play a crucial role in ensuring the scientific rigor, regulatory compliance, and operational integrity of clinical trials

WHAT THIS STUDY ADDS

- The study evaluated the effectiveness of a comprehensive training intervention designed to standardize and enhance core competencies of clinical trial coordinators in Africa, where they often lack access to structured, competency-based training

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

The authors have declared no competing interest.

This effort was made possible through funding from the Gates Foundation (Grant No.: INV-055202). The content is solely the responsibility of the authors.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Scientific and Ethics Review Committee of the Center for Innovative Drug Development and Therapeutic Trials for Africa, Addis Ababa University, approved the study

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All data produced in the present study are available upon reasonable request to the authors