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臨床監(jiān)查員 II（外派外資藥廠）

1.3-1.6萬·14薪

上海黃浦區(qū)
1-3年
本科
全職
招16人

職位描述

藥品臨床監(jiān)查腫瘤

職責(zé)要求：

Drive performance at the sites. Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents . Provide the required monitoring visit reports within required timelines. Proactively identify study-related issues and escalates to Local Study Teams as appropriate.
Contribute to the selection of potential investigators. Train, support and advise Investigators and site staff in study related matters.
Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations. Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
Perform source data verification according to SDV plan. Ensure data query resolution. Work with data management to ensure quality of the study data.
Ensure accurate and timely reporting of Serious Adverse Events.
Share relevant information on patient recruitment and study site progress within local Study Team. Update VCV and other systems with data from centres as per required timelines
Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.

· 任職資格：

Bachelor degree in biological science or healthcare-related field, or equivalent

· Minimum 2-year experience as CRA or other related fields. Experience as a clinical monitor, performed all tasks for a CRA position.

Knowledge of the Monitoring Process, such as understanding of the Study Drug Handling Process and the Data Management Process, etc.

· Understanding of the clinical dataflow · Solid knowledge of the clinical study and drug development processes, GCP/ICH guidelines and relevant local regulations · Good computer skills in Microsoft and other software. · Fluent in both oral and written English.

Proficient written and verbal communication skills, collaboration and interpersonal skills.

工作地點(diǎn)

上海黃浦區(qū)Soho復(fù)興廣場

完善一份簡歷
1736萬+企業(yè)在線搜索，780萬+海量職位精準(zhǔn)推薦

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上海康德弘翼醫(yī)學(xué)臨床研究有限公司

康德弘翼（WuXi Clinical），是藥明康德（WuXi AppTec）的一家全資子公司。始終致力為全球客戶提供全方位的臨床研究服務(wù)，包括藥品、生物制品、醫(yī)療器械、體外診斷試劑等醫(yī)藥產(chǎn)品，涵蓋BE(Bioequivalence)/ I期至IV期的臨床試驗(yàn)。通過嚴(yán)格的質(zhì)量控制體系和專業(yè)團(tuán)隊(duì)的豐富經(jīng)驗(yàn)，幫助創(chuàng)新性，突破性醫(yī)藥產(chǎn)品盡快上市和造福患者。康德弘翼立足中國，面向世界，以上海總部為中心，輻射全球制藥公司、生物技術(shù)公司以及醫(yī)療器械公司。目前，公司實(shí)行全球聯(lián)合運(yùn)營，人員規(guī)模達(dá)850+人，運(yùn)營能力覆蓋中國、美國及澳大利亞等，并在上海、北京、廣州、武漢、成都、長沙、西安、沈陽、中國臺北、美國奧斯汀、美國圣地亞哥和澳大利亞悉尼等地均設(shè)有辦公室。公司團(tuán)隊(duì)與各研究中心建立了良好的合作關(guān)系，始終保持著緊密的業(yè)務(wù)交流，保證了項(xiàng)目能高效、高質(zhì)地完成。隨著業(yè)務(wù)能力和業(yè)務(wù)范圍的不斷拓展，康德弘翼進(jìn)一步完善和增強(qiáng)了全球一體化研發(fā)服務(wù)平臺的綜合實(shí)力，助力全球創(chuàng)新合作伙伴更好、更快地開發(fā)醫(yī)藥產(chǎn)品。

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