Activities and Role Perceptions of Clinical Research Nurses in Participating Italian Scientific Research Hospitals: A Multicentre Cross-Sectional Survey

Abstract

Highlights What are the main findings? Clinical research nurses rated all surveyed activities as highly important, but their reported involvement was uneven and concentrated on trial implementation and investigational medicinal product management rather than protocol assessment and planning. Workload-related stress and role ambiguity were reported by 48% and 39% of respondents, respectively, despite generally high perceived role adequacy and job satisfaction. What are the implications of the main findings? Italian research hospitals should involve clinical research nurses earlier in protocol development and planning and define their competencies consistently across institutions. Structured education, career pathways and organisational support are needed to reduce role ambiguity and make fuller use of clinical research nurses’ expertise, potentially improving trial quality and workforce sustainability. Abstract Background/Objective: Clinical research nurses (CRNs) support participant care and trial conduct, yet their role is inconsistently recognised and integrated in Italian Scientific Institutes for Research, Hospitalisation and Healthcare (IRCCSs). This study aimed to describe the perceived importance and self-reported frequency of CRN activities, professional-role perceptions and selected organisational characteristics among CRNs working in participating Italian IRCCSs. Methods: A cross-sectional online survey used the validated Italian Clinical Trials Nursing Questionnaire (149 items; 12 sections) via REDCap. All 53 IRCCSs were contacted. Eligible nurses worked in an IRCCS and devoted at least 50% of their working time to research-related nursing activities. Complete eligible questionnaires were summarised descriptively. Results: Twenty-five IRCCSs provided contacts and 308 CRNs were invited; 167 questionnaires were completed and 149 were eligible. Respondents had a median age of 38 years (IQR 31.5–48.5) and 4 years of CRN experience (IQR 2–7.5); 19% were male. Mean perceived importance was high across activity sections (4.06–4.65), while mean frequency varied (2.90–4.08). Protocol assessment (2.90) and planning (2.99) were least frequent; investigational medicinal product management (4.08) and implementation/evaluation (3.88) were more frequent. Workload-related and role-ambiguity stress were reported by 48% and 39%, respectively, despite high role adequacy (86%) and job satisfaction (81%). Conclusions: CRNs considered all assessed functions important, but their involvement was concentrated in trial delivery rather than upstream protocol work. Respondents with higher education reported more frequent involvement in protocol assessment/planning, recruitment, and informed consent, although these findings are descriptive.