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工作職責(zé)
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(xiàng)目文檔管理計(jì)劃、SOP、ICH-GCP/中國(guó)GCP進(jìn)行項(xiàng)目文檔的回收和保存工作，負(fù)責(zé)對(duì)項(xiàng)目文檔進(jìn)行QC，并將無(wú)誤的文件進(jìn)行掃描保存在Sharepoint/e-TMF，確保文件的完整性和回收的及時(shí)性。
2. Be responsible for the daily management and maintenance of the TMF.
負(fù)責(zé)項(xiàng)目核心文檔的日常管理和維護(hù)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(xiàng)目經(jīng)理制定試驗(yàn)項(xiàng)目需要的項(xiàng)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(jìn)行機(jī)構(gòu)立項(xiàng)，倫理資料的準(zhǔn)備工作。
5. Assist in the contract signing and stamping work in the project.
協(xié)助試驗(yàn)項(xiàng)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(fù)責(zé)試驗(yàn)費(fèi)用申請(qǐng)的支持工作，并跟蹤費(fèi)用的支付情況，及時(shí)反饋給臨床項(xiàng)目經(jīng)理和CRA。在費(fèi)用支付后，負(fù)責(zé)跟蹤發(fā)票的回收和銷(xiāo)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(fù)責(zé)試驗(yàn)費(fèi)用的記錄和匯總，每月完成費(fèi)用使用報(bào)告，提交給臨床項(xiàng)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(fù)責(zé)將定期從PV處獲得的SUSAR Listing，寄送給相關(guān)的倫理委員會(huì)，跟蹤?quán)]件的到達(dá)情況，并及時(shí)獲得回執(zhí)。
9. Be responsible for the procurement, distribution, calibration and tracking of project materials.
負(fù)責(zé)試驗(yàn)物資的采購(gòu)，分發(fā)，校準(zhǔn)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(xiàng)目經(jīng)理進(jìn)行試驗(yàn)項(xiàng)目中供應(yīng)商的日常溝通和管理工作，并及時(shí)將遇到的問(wèn)題反饋給臨床項(xiàng)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(jìn)行試驗(yàn)用藥品的申請(qǐng)工作，跟蹤試驗(yàn)用藥品的運(yùn)輸情況，確保試驗(yàn)用藥品能夠及時(shí)到達(dá)研究中心，如有問(wèn)題及時(shí)將情況反饋給CRA、臨床項(xiàng)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(xiàng)目和相關(guān)會(huì)議的支持工作。
13. Be responsible for daily assistance in the trail project.
負(fù)責(zé)試驗(yàn)項(xiàng)目中的日常協(xié)助事務(wù)。
任職資格
1. Good communication skills and proactive work attitude.
良好的溝通技巧和積極主動(dòng)的工作態(tài)度。
2. Proactive and independent work ability.
積極主動(dòng)，獨(dú)立工作能力強(qiáng)。
3. Listening, speaking, reading, and writing skills in the language used in the local country, and good English listening, speaking, reading, and writing skills.
當(dāng)?shù)貒?guó)家使用的語(yǔ)言的聽(tīng)說(shuō)讀寫(xiě)能力，并有良好的英語(yǔ)聽(tīng)說(shuō)讀寫(xiě)能力。
4. Willingness to work with multiple supervisors/colleagues in a multi-functional environment, valuing the importance of teamwork.
在多個(gè)職能部門(mén)環(huán)境中與多個(gè)主管/同事合作的意愿，重視團(tuán)隊(duì)合作的重要性。
1. 1-2 years relevant work experience, fresh graduates are acceptable.
1-2年相關(guān)工作經(jīng)驗(yàn)，可接受應(yīng)屆畢業(yè)生。
2. College's (or above) degree in a medicine-related major.
醫(yī)藥學(xué)相關(guān)專業(yè)的專科（或以上）學(xué)位。