*在臨床項目負責團隊的指導下執行工作。
*可與臨床試驗團隊合作制定特定研究計劃和/或流程
*進行預研究(機構資格篩選)、啟動、中期監測和結束訪問
*準備試驗機構訪問報告和確認/後續回覆
*根據試驗監測計劃與試驗機構進行定期聯繫並記錄
* 確保數據收集時間表和其成果按照在試驗機構符合試驗計劃內容。
* 與數據管理部門合作處理數據質疑工作
*依據試驗計畫和提交IRB/EC審核過的計畫內容監測試驗機構及辨識和回報試驗偏差。
*確保試驗機構遵守 SAE 報告計畫的每個協議並符合研究計劃
* 確保機構遵守研究協議並遵守臨床試驗相關法規(ICH/GCP)。為研究人員提供適當的訓練。
* 協助執行糾正措施,以解決研究中的不合規問題,包括常規訪視和品質保證審核
*追踪和報告試驗機構的進度,包括受試者篩選/註冊、數據收集、不良事件記錄和處理常見問題。
* 與內部 CRA 或指定人員合作收集、審查和追踪試驗文件,以確保試驗文件和公司中央檔案的完整性。
* 提供持續的研究相關培訓(如 EDC)並在必要時為機構研究人員提供協助
*在試驗機構管理及清點臨床試驗藥物/醫材產品,以及臨床/非臨床用品庫存,並酌情監控退貨文件。
*確保正確收集、儲存和運送實驗室樣本
*參與臨床試驗團隊會議
*協助安全管理部門收集 AE/SAE 文件以進行報告
*與試驗機構保持良好關係並快速解決任何試驗機構問題
*其他交辦事項。
*Performs job with general guidance and direction from our Clinical Project Lead, Clinical Trial Manager, or designees.
*May collaborate with the Clinical Trial Manager, in-house CRA, or designee on the development of certain study-specific plans and/or processes
*Conducts pre-study (site qualification), initiation, interim monitoring and closeout visits
*Prepares site visit reports and confirmation/follow-up letters to sites
*Conducts and documents periodic telephone contact with sites in accordance with the monitoring plan
*Ensures data collection timelines and deliverables are met at assigned clinical sites in accordance with study plans
*Works with Data Management in the query resolution process
*Identifies and reports protocol deviations in accordance with study plans and monitors site submissions to IRB/EC per reporting policies.
*Ensures site compliance to SAE reporting policy per protocol and in accordance with study plans
* Ensures site adherence to study protocols and compliance with ICH/GCP/local regulations at assigned clinical sites. Provides the appropriate training / retraining to the site personnel.
* Implementation of corrective actions for addressing non-compliance issues at individual sites and across study, including follow-up to routine and for-cause Quality Assurance audits
*Tracks and reports progress of assigned site(s) including subject screening/enrollment, data collection, adverse event documentation, and Frequently Asked Questions
* Partners with the in-house CRA or designee in the collection, review, and tracking of clinical trial documents to ensure completeness of both site files and company Central Archive
* Provides ongoing study-related training (i.e. EDC) and support to site staff as necessary
*Manages Drug / Medical device product and inventory of clinical / non-clinical supplies at assigned sites and monitors documentation of returns as appropriate.
*Ensures proper collection, storage, and shipment of laboratory specimens
* May participate in Clinical Trial Team Meetings
*Assists Safety with the collection of AEs/SAEs documentation for reporting purposes
*Maintains good relationships with the assigned sites and works quickly to resolve any site issues and mentoring of new employees as assigned. e.g. co-monitoring.
*Perform other duties as assigned by management team.