Enhancing competency in clinical trials management: Findings from a multicountry trial coordinators interventional training program

Abstract

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, McNemars 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, SD 7.85 (out of a maximum of 25) to 23.35, CD 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. Keywords: Clinical trial, trial coordinators, Africa, training, research management, competency.