[[alternative]]Job Analysis of Clinical Research Nurses in Taiwan:Modular Employability Courses

[[abstract]]臨床試驗品質深受研究護理師執業能力的影響，為了提供其就業課程設計所需要的實證性資料，本研究建構與確認臨床研究護理師在台灣人體試驗職場四類領域(新藥品、新醫療技術、新醫療器材以及學名藥生體可用率、生體相等性等)的共同職責與核心任務步驟。經過兩個階段達成本研究目的，階段一在描述與建構研究護理師在四類的共同工作職責與任務，首先深度訪談四類領域各2~4位研究護理師因應最常見與最重要工作情境須具備的能力，共獲得有效文字稿11份。再依據工作任務訊息處理分析法及流程繪製原則，各領域的資料分析獲得 (一)共同職責(準備試驗、執行試驗、結案、維護試驗案的品質)；(二) 四類領域的任務流程(新藥領域13項、新醫療技術領域12項、新醫療器材領域12項、學名藥生體可用率/生體相等性領域12項)； 再依據文獻考察結果 (三)命名與定義任務、排序與說明特定的步驟；（四）設計任務規準檢核表。階段二在確認四類的共同核心任務，做為未來進一步發展任務為基礎的就業模組課程之依據。由四類領域推薦各2~3位資深臨床研究護理師參與二場焦點團體會議。先分四組確認各領域任務的名稱與定義、流程與步驟說明、任務規準檢核表﹔再合組確認出四類領域的14項「共同核心任務」。[[abstract]]The quality of clinical trials is markedly influenced by the competency of clinical research nurses. An employability curriculum must provide be rooted in the evidence-based practices. This study identified the common duties and tasks of research nurses working on human trials in Taiwan. A human trial is experimental research that assess the effects, both positive and negative, of, say, a new medical technology, new drug, new medical procedure, or the bioavailability and bioequivalence of generic drugs. This study had two phases. The first phase described and identified the common duties and tasks of clinical research nurses in four areas of a human trial: new medical technology; new drug; new medical procedure; and the bioavailability and bioequivalence of generic drugs. In-depth interviews with each area 2–4 nurses in each area were conducted to determine the importance and occurrence of theses duties. Eleven valid transcripts were obtained. According to cognitive task analysis and principles of flow chart design, data for the four areas were analyzed, : (a) common duties (pre-study , study period, study close-out, and quality assurance); (b) tasks in the four areas (13 new medicines, 12 new medical technologies, 12 new medical procedures, 12 bioavailability and bioequivalence studies of generic drugs); according to literature review results, (c) the named and defined tasks were sorted and characterized; and (d) a checklist was developed of for each task. The second phase identified the common tasks of in the four areas, as the basis of for modular courses for the further development of skills. In total, 2 or 3 senior clinical research nurses from each area participated in group meetings. The four groups confirmed the accuracy of each task’s name, and definition, and procedural description. Finally, there are 14 common tasks in the four areas of human trails were identified