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崗位職責:

1.Recycle and save project documents according to the project document management plan, SOP, ICH-GCP/China GCP, be responsible for QC of project documents, and scan and save the correct documents in Sharepoint/e-TMF to ensure integrity of file and timeliness of recycling.

根據(jù)項目文檔管理計劃、SOP、ICH-GCP/中國GCP進行項目文檔的回收和保存工作，負責對項目文檔進行QC，并將無誤的文件進行掃描保存在Sharepoint/e-TMF，確保文件的完整性和回收的及時性。

2.Be responsible for the daily management and maintenance of the TMF.

負責項目核心文檔的日常管理和維護工作。

3.Assist the clinical project manager to formulate project documents and related forms required by the trial project.

協(xié)助臨床項目經(jīng)理制定試驗項目需要的項目文件和相關(guān)表格。

4.Assist CRA in the application of institutional projects and the preparation of ethical materials.

協(xié)助CRA進行機構(gòu)立項，倫理資料的準備工作。

5.Assist in the contract signing and stamping work in the project.

協(xié)助試驗項目中的合同簽署和蓋章工作。

6.Be responsible for supporting the application of trial fees, tracking the payment of fees, and timely feedback to clinical project manager and CRA. Responsible for tracking the recovery and write-off of invoices after payment is made.

負責試驗費用申請的支持工作，并跟蹤費用的支付情況，及時反饋給臨床項目經(jīng)理和CRA。在費用支付后，負責跟蹤發(fā)票的回收和銷賬工作。

7.Be responsible for the recording and summarization of trial expenses, complete the monthly expense report, and submit it to clinical project manager.

負責試驗費用的記錄和匯總，每月完成費用使用報告，提交給臨床項目經(jīng)理。

8.Be responsible for regularly sending the SUSAR Listing obtained from PV to the relevant ethics committee, tracking the arrival of the mail, and obtaining a receipt in time.

負責將定期從PV處獲得的SUSAR Listing，寄送給相關(guān)的倫理委員會，跟蹤?quán)]件的到達情況，并及時獲得回執(zhí)。

9.Be responsible for the procurement, distribution, calibration and tracking of project materials.

負責試驗物資的采購，分發(fā)，校準及跟蹤工作。

10.Assist clinical project manager in the daily communication and management of vendor in the trial project, and timely feedback the problems encountered to clinical project manager and clinical trial support manager.

協(xié)助臨床項目經(jīng)理進行試驗項目中供應商的日常溝通和管理工作，并及時將遇到的問題反饋給臨床項目經(jīng)理和臨床支持經(jīng)理。

11.Assist CRA in the application of investigational products (IPs), track the transportation of investigational products (IPs), ensure that the investigational products (IPs) can arrive at the site in time, and report the situation to CRA, clinical project manager and clinical trial support manager in time if there are any problems. (if applicable)

協(xié)助CRA進行試驗用藥品的申請工作，跟蹤試驗用藥品的運輸情況，確保試驗用藥品能夠及時到達研究中心，如有問題及時將情況反饋給CRA、臨床項目經(jīng)理和臨床支持經(jīng)理。（如適用）。

12.Assist with project and related meeting support.

協(xié)助項目和相關(guān)會議的支持工作。

13.Be responsible for daily assistance in the trail project.

負責試驗項目中的日常協(xié)助事務。