Study Coordinator

2 weeks ago


Selangor, Malaysia Clinical Research Malaysia Full time

**主要責任**

研究協調員的任務;
- 向副區域經理報告。
- 從醫院和衛星站點更新研究者資料庫、研究者 GCP 清單和可行性日誌。
- 管理和協調從可行性團隊收到的可行性研究,包括會見有興趣的新的和潛在的調查員。支持並追蹤可行性問卷在時限內的完成情況。
- 向副區域經理提交有關 ISR 狀態的月度 ISR 報告,包括即將進行的新試驗、正在進行的試驗、試驗的結束狀態。
- 向副區域經理通報專案現場任何新的潛在研究並更新情況。
- 協助贊助商/CRO準備和進行實地考察,包括但不限於場址選擇考察、場址啟動考察、場址監測考察、場址關閉考察等。
- 充當研究者和其他臨床研究利益相關者(包括 CRO/申辦者、監管機構和其他機構)之間的聯絡人,以支援現場審核和檢查準備工作以及隨後酌情實施建議的糾正措施。
- 指導並支持研究者研究預算的支付過程。
- 根據方案、SOP 和適用指南執行研究者委託的任務。
- 根據授權並依照 SOP 進行預先篩選活動,協助招募研究對象。
- 安排和管理受試者訪視。根據方案在受試者訪視期間協助研究者。
- 確保及時準確地完成病例報告表 (CRF)/e-CRF 並解決疑問。
- 處理和準備供供應商收集的樣本。
- 處理研究產品 (IP) 並管理 IP 的儲存和記錄,包括補給、分配、維護 IP 的責任。
- 處理臨床用品並管理其儲存和記錄,包括補給、分配、維持 IP 的責任。
- 協助研究人員進行受試者安全管理,包括及時向相關當局報告(初始/完整)SAE。
- 遵守 ISO 9001:2015 要求下提供的所有標準作業程序和指南。
- 確保與臨床操作相關的活動符合良好臨床實務 (GCP) 和 ISO 標準。

**基本工作要求**
- 生物醫學/生物技術/護理學位
- 臨床試驗知識對於適應工作要求至關重要
- 具有研究領域/臨床經驗
- 一絲不苟、細節豐富、組織良好,能夠按時完成獨立工作
- 優秀的溝通和人際交往能力
- 足智多謀,能夠同時處理多項任務
- 通過 GCP 認證,完成實務訓練和訓練日誌


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