眼科研究型医院是推动医学创新与成果转化的核心平台。其中，专职临床研究护士（clinical research nurse，CRN）在提升临床研究的规范性及整体质量方面发挥着不可或缺的作用。然而，当前国内尚缺乏针对眼科领域CRN管理模式的系统总结和实践指导，制约了该群体专业价值的充分发挥和制度化建设的推进。本研究以中山大学中山眼科中心（三级甲等眼科研究型医院）2013—2024年间的CRN管理实践为样本，系统梳理其管理体系的构建路径与实施成效。研究发现，通过构建“准入-培训-双轨管理”体系和实践模式，能够显著提升CRN队伍的专业能力和研究项目的整体质量。机构质控数据显示，配备CRN后的研究项目质量评分由（67.5±17.2）分显著提升至（99.3±1.0）分（P<0.001），证实了该体系的有效性和可行性。研究结果还为我国眼科临床研究护理专业化发展提供了可复制的实践模板，还进一步分析提炼出CRN的三项核心职能：一是项目管理中的流程优化，保障研究环节高效协同；二是参与者管理，强化对受试者权益的保护；三是数据质量控制，确保研究数据的准确性与完整性。在此基础上，针对当前CRN发展中普遍存在的职责不清、培训缺失、政策滞后等问题，本文还提出推动“层级化培训常态化”“政策规范细则化”等优化建议，助力我国眼科临床研究由“经验驱动”向“体系驱动”转型，为临床研究护理专业化提供实践模板和决策参考。

Ophthalmic research hospitals serve as critical platforms for advancing medical innovation and translating research outcomes into practice. Dedicated Clinical Research Nurses (CRNs) play a pivotal role in enhancing the quality, compliance, and integrity of clinical research conducted within these settings. However, in China, there remains a lack of systematic models and practical guidance for CRN management specific to the field of ophthalmology, which has hindered the full realization of their professional value and the advancement of institutionalized development. This study examined CRN management practices at Zhongshan Ophthalmic Center, Sun Yat-sen University, a Grade A tertiary ophthalmic research hospital, between 2013 and 2024 as a case example to systematically examine the development pathway and outcomes of its CRN management system. The findings demonstrate that the implementation of a standardized system encompassing entry qualifications, tiered training, and structured practice models significantly enhanced both the professional competency of CRNs and the overall quality of clinical research projects. According to institutional quality control data, the quality score of clinical research projects increased significantly from 67.5±17.2 to 99.3±1.0 (P<0.001) following the integration of CRNs. Moreover, the study identifies three core functional domains of CRNs: (1) optimizing research processes to improve project coordination and efficiency; (2) managing research participants to safeguard ethical compliance and rights protection; and (3) ensuring data quality and integrity through rigorous oversight. In response to persistent challenges such as unclear role definitions, insufficient training systems, and lagging policy support, the study proposes actionable strategies, including the institutionalization of hierarchical and continuous training as well as the refinement of policy frameworks. These findings provide a scalable and evidence-based reference for promoting the professionalization and systemic development of ophthalmic clinical research nursing in China.