岗位职责:

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.

根据项目文档管理计划、SOP、ICH-GCP/中国GCP进行项目文档的回收和保存工作，负责对项目文档进行QC，并将无误的文件进行扫描保存在Sharepoint/e-TMF，确保文件的完整性和回收的及时性。

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

负责项目核心文档的日常管理和维护工作。

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

协助临床项目经理制定试验项目需要的项目文件和相关表格。

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

协助CRA进行机构立项，伦理资料的准备工作。

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

协助试验项目中的合同签署和盖章工作。

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.

负责试验费用申请的支持工作，并跟踪费用的支付情况，及时反馈给临床项目经理和CRA。在费用支付后，负责跟踪发票的回收和销账工作。

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

负责试验费用的记录和汇总，每月完成费用使用报告，提交给临床项目经理。

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.

负责将定期从PV处获得的SUSAR Listing，寄送给相关的伦理委员会，跟踪邮件的到达情况，并及时获得回执。

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

负责试验物资的采购，分发，校准及跟踪工作。

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.

协助临床项目经理进行试验项目中供应商的日常沟通和管理工作，并及时将遇到的问题反馈给临床项目经理和临床支持经理。

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)

协助CRA进行试验用药品的申请工作，跟踪试验用药品的运输情况，确保试验用药品能够及时到达研究中心，如有问题及时将情况反馈给CRA、临床项目经理和临床支持经理。（如适用）。

12.Assist with project and related meeting support.

协助项目和相关会议的支持工作。

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

负责试验项目中的日常协助事务。