SOURCES OF BURNOUT OF CLINICAL MONITORS AND STAFF TURNOVER IN CONTRACT RESEARCH ORGANIZATIONS

Abstract

The relevance of this research is driven by the rapid expansion of the clinical trials industry and the resulting shortage of Clinical Research Associates (CRAs), which has intensified human resource risks in Contract Research Organizations (CROs). Professional burnout and high staff turnover pose critical threats to project stability, as CRAs perform a broad spectrum of operational tasks, ranging from data quality oversight to coordination among study stakeholders. Within matrix organizational structures, resource allocation conflicts and insufficient managerial involvement frequently become key triggers of burnout. The aim of the study is to identify the main organizational, structural, and psychological factors that generate risks of burnout and turnover among CRAs, as well as to determine causal relationships between job stress, managerial practices, and employees’ intention to leave the company. The methodology is grounded in systemic, process-based, and risk-oriented approaches. Methods applied include system analysis, content analysis, synthesis, comparative analysis, and correlation analysis of data from prior international studies. The results reveal: the systemic nature of human resource risks; the significant impact of horizontal conflicts between functional and project managers; the critical role of inadequate workload distribution and the absence of competency assessment tools; and statistically significant correlations between stress, burnout, and turnover intention. A mismatch was identified between the actual drivers of staff turnover and organizational responses, which often fail to address the root causes. Future research directions include developing a risk-based HR policy model for CROs, creating tools for early detection of CRA burnout, improving competency assessment frameworks, and evaluating the effectiveness of different matrix management models in reducing staff turnover.