1.參與臨床試驗相關計畫送審、執行、追蹤,負責國外窗口接洽。
2.負責臨床審查過程中的跨部門協作,法規單位溝通,確保項目有效執行。
3.協助篩選適合執行專案之廠商及相關合約與經費協調、試驗文件準備。
4.協助試驗監測訪視、試驗執行進度管理、試驗資料整理、確保試驗執行符合GCP、計畫書與相關法規規定。
5.追蹤產業發展和新的法規要求,確保團隊具備最新臨床試驗知識和技能。
6.彙整國內外相關資料文獻、臨床數據與製作簡報。
7.撰寫及發表研發成果、科學文獻。
8.協助臨床專案成果報告 ex:國際會議主持、文件準備。
9.執行主管交辦其他事項與跨部門溝通。
1. Participate in the submission, execution, and follow-up of clinical trial-related projects; handle international affairs coordination.
2. Responsible for cross-departmental collaboration during the clinical review process, communicating with regulatory agencies to ensure effective project execution.
3. Assist in selecting suitable vendors for project execution, coordinating related contracts and budgets, and preparing trial documentation.
4. Assist in trial monitoring visits, manage trial execution progress, compile trial data, and ensure compliance with GCP, protocols, and relevant regulations.
5. Track industry developments and new regulatory requirements to ensure the team possesses the latest knowledge and skills in clinical trials.
6. Read and gather relevant domestic and international medical journals and clinical information, and create presentations.
7. Write and publish research findings and scientific literature.
8. Assist with clinical project outcome reporting, such as hosting international conferences and preparing documentation.
9. Execute other tasks assigned by supervisors and facilitate cross-departmental communication.