关键词: 临床研究护士；角色职责；核心能力；培养；综述

Abstract: As core members of clinical trial teams, clinical research nurses play a key role in comprehensive management and quality assurance throughout the trial lifecycle. With the rapid development of the clinical trial in China, the professional development of clinical research nurses has become one of a critical factor influencing the standardization of clinical research practices. This review systematically summarizes the current roles, core competencies, and educational development status of clinical research nurses in China, highlighting persistent challenges in role definition and existing educational frameworks. It also proposes targeted strategies to enhance professional standardization and facilitate career advancement for clinical research nurses.

Key words: clinical research nurse; role responsibility; core competency; cultivation; review