臨床監測員 Clinical Research Associate, CRA (Contract-中部/北部地區)

*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.