建置臨床研究護理師之研究管理能力教育訓練課程方案

研究目的:探討臨床研究護理師(CRN)之研究管理能力與教育訓練需求，進而發展研究管理職能內容，並建置臨床研究護理師之研究管理能力的教育訓練課程大綱。方法:本研究以立意取樣，採取問卷調查法及德爾菲法分兩階段進行，第一階段參考研究護理師專業發展與活動之相關文獻，綜整研究管理活動項目及職能。邀請20位臨床研究產業之研究對象填寫問卷後，以SPSS 26.0套裝軟體進行描述性統計分析。第二階段則參照勞動部公告之「新藥開發人員職能基準」，編製德爾菲法專家問卷，內容包括工作任務、職級與行為和知識、技能及態度之職能基準；邀請7位具CRN認證資格者擔任專家，進行問卷填寫，經由兩回合之意見調查，達成專家一致性共識，至此完成CRN研究管理職能內容之確立。並建置CRN研究管理能力之課程大綱。結果:(1)確立12項研究管理活動項目與79項職能；(2)建置並確認CRN Level 1至Level 4之12項知識與技能面向與10項態度面向的職能基準；(3)建置CRN研究管理課程大綱，包含課程主題、描述與目標。結論與應用:「人才(Talent)」是產業發展與成功的關鍵條件，而「研究管理」臨床研究護理師的主要專業範疇之一，佔總工作時數的50%以上。本研究建置臨床研究護理師之研究管理職能基準與課程，可成為CRN職涯路徑建置、磁吸專業營造與CRN專業教育參考；聘僱機構之選、育、用、留及績效評核指標參考，並擴展應用於協助臨床研究產業人才培訓制度的建立，改善學用落差之現況，進而提升台灣在全球臨床研究產業之可見度與影響力。

關鍵字

臨床研究；研究管理；專業職能

並列摘要

Objective: To identify the dimension of study management and educational training needs in the field of clinical research nursing，then develop the occupational competency standard (OCS) content and establish the training curriculum outline for clinical research nurses in Taiwan. Method: The study is in purposive sampling, using survey method and Delphi survey to collect related data. According to the relevant literature review regarding the professional clinical nursing activities and development, then elaborate the study management competency and activities. The software package of SPSS 26.0 for descriptive statistical analysis for 20 completed questionnaires. The Delphi survey is referring from the occupational competency standard (OCS) for talent of new drug development from Ministry of Labor. The OCS content include work tasks、 position level and professional knowledge、skill and attitude. Seven certificated professional clinical research nurses were invited as the expert to complete 2 cycles of the survey and achieve the consensus. Thus, completing the establishment of CRNs’ study management OCS. The last stage is to construct the curriculum syllabus for study management competency. Result: (1)Established 12 study management activities and 79 competency；(2)Established and confirmed the content of occupational competency standard (OCS) which include 12 aspects of knowledge and skill, also 10 attitude aspects for CRN Level 1 to Level 4；(3)Constructed a specific CRN’s study management training curriculum outline, include topic、description and procedure. Conclusion: Talent is the key element for a successful development in the industry. Study management is the essential professional domain, accounting for more than 50% of the total working hours. This study established the OCS and education course, which can be a reference for CRN career path development、magnetic working environment and CRN professional education. The industry can referenced for talent selection、coaching、developing、retention and performance evaluation. Moreover, to narrow the gap between industry demand and talent supply, the study result can apply to the clinical research field for the talent training system set up. To enhance Taiwan’s visibility and influence in the global clinical research industry.