Global Role Standards for Clinical Research Nurses (CRNs) and the Need for Official Title Recognition and Institutionalization in South Korea

This review compares international systems and role standards for Clinical Research Nurses (CRNs) and proposes the need to establish an official title and role definition in Korea.In major countries such as the United States, the United Kingdom, and the European Union (EU), national authorities have institutionalized the legal definition, job descriptions, ethical and Good Clinical Practice (GCP) standards, educational systems, and career development frameworks for CRNs.In contrast, in Korea, although nurses actively participate in clinical research, undertaking key responsibilities such as patient care, clinical intervention, and protocol management, the title 'Clinical Research Nurse' has not been officially defined, and there is no consensus on its use.Most institutions instead use the broader, less clearly defined title of 'Clinical Research Coordinator (CRC)', under which the roles and scope of nursing practice remain ambiguous.This review employs a Global Network Analysis approach to identify the common international roles of CRNs and to discuss the need for establishing an official title and institutional framework within the Korean clinical research environment.To this end, it examines: 1) the institutionalization and operational status of CRNs worldwide; 2) the current status and regulatory context of CRN practice in Korea; 3) existing operational limitations; and 4) potential policy improvements derived from global role standard comparisons.Such institutionalization will not only enhance the quality of clinical trials, strengthen protections for research participants, and ensure professional recognition for nurses.Still, it will also provide a crucial foundation for advancing the global competitiveness of Korean nurses by aligning with international guidelines.