Integrated risk-based human resource management in the clinical trial project organizations
DOI:
https://doi.org/10.31558/2307-2318.2025.2.6Keywords:
human resource management, human resource risks, communication, trainings, competence, organizationAbstract
The article is dedicated to strategic human resource management in clinical research organizations. It addresses the problem of staffing shortages among Clinical Research. Associates (CRAs). The authors propose an integrated, risk-oriented approach to personnel management. High staff turnover and a shortage of specialists with specific competencies pose significant risks, threatening the budget, quality, and deadlines of clinical research projects. The proposed method, called sequential-parallel engagement, involves phased training and support of junior CRAs by senior colleagues. This approach promotes gradual development of competencies, increases motivation, and helps retain staff within the organization. The method also allows for reducing sponsor and contract research organization (CRO) costs, as well as decreasing the workload on Senior CRAs. The model is effective provided there is a clear understanding of the seriousness of risks, transparency in the sponsor-CRO relationship, proper planning, alignment, and adherence to the sequential processes and requirements of ICH GCP. The economic part of the article demonstrates that training mid-level CRAs can replace Senior CRAs, reducing monitoring visit costs by nearly 63% after just four months of the implementation.
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