2026 年 57 巻 5 号 p. 111-123
Clinical research coordinators (CRCs) play a central role in ensuring the scientific validity and ethical conduct of clinical trials; however, they have been reported to experience substantial psychological burden in the course of their work. In Japan, CRCs are broadly categorized into hospital-based CRCs, who are employed by medical institutions, and SMO-CRCs, who are employed by site management organizations (SMOs) and dispatched to medical institutions. In a previous study, we explored resilience factors among hospital-based CRCs in order to obtain implications for educational interventions aimed at fostering resilience and alleviating psychological burden among CRCs. Building on this work, the present study aimed to explore resilience factors among SMO-CRCs. Semi-structured interviews were conducted with eight female SMO-CRCs with more than 10 years of professional experience, and the data were qualitatively analyzed. The findings indicated that, as with hospital-based CRCs, four groups of resilience factors were identified among SMO-CRCs: (1) individual characteristics and ways of thinking, (2) meaning, goals, and motivation, (3) ways of dealing with work and ability to perform work, and (4) support from those around them. In addition, several factors characteristic of SMO-CRCs were identified, including acceptance of difficult situations, role perceptions emphasizing tangible outcomes such as meeting deadlines and achieving participant enrollment, and a support structure centered on work-related personnel. These findings suggest that, given the distinct adaptation mechanisms across different institutional settings of CRCs, their psychological burden should not be treated solely as a matter of individual resilience; instead, it must be evaluated in relation to organizational and environmental support structures.
