Clinical Research Nurses: Roles and Qualifications in South Korea

Abstract

This study aimed to determine the standard roles, proficiency, and qualification of clinical research nurses (CRNs) in clinical trials/research in South Korea. Seventy-one investigators with experience working with CRNs and 79 current CRNs were conveniently sampled. Data were collected using a questionnaire including demographics, perceived roles, proficiency, and qualification of CRNs. The top three roles of CRNs perceived by investigators were scheduling subjects, communicating with investigator and sponsor, and completing case report forms. The top three roles of CRNs perceived by current CRNs were completing case report forms, communicating with investigator and sponsor, and screening subjects. The most important proficiencies perceived by investigator and current CRNs was communication and human relationship skills. Both investigators and current CRNs considered the key role of CRNs as communicating with investigator and sponsor; a bachelor’s degree and more than one year of clinical experience were seen as the minimum qualification.