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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

上海黃浦區(qū)Soho復興廣場

職位發(fā)布者

董雅喬/招聘經理

立即溝通
公司Logo上?？档潞胍磲t(yī)學臨床研究有限公司
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，包括藥品、生物制品、醫(yī)療器械、體外診斷試劑等醫(yī)藥產品，涵蓋BE(Bioequivalence)/ I期至IV期的臨床試驗。通過嚴格的質量控制體系和專業(yè)團隊的豐富經驗，幫助創(chuàng)新性，突破性醫(yī)藥產品盡快上市和造?；颊摺？档潞胍砹⒆阒袊嫦蚴澜?，以上海總部為中心，輻射全球制藥公司、生物技術公司以及醫(yī)療器械公司。目前，公司實行全球聯(lián)合運營，人員規(guī)模達850+人，運營能力覆蓋中國、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有辦公室。公司團隊與各研究中心建立了良好的合作關系，始終保持著緊密的業(yè)務交流，保證了項目能高效、高質地完成。隨著業(yè)務能力和業(yè)務范圍的不斷拓展，康德弘翼進一步完善和增強了全球一體化研發(fā)服務平臺的綜合實力，助力全球創(chuàng)新合作伙伴更好、更快地開發(fā)醫(yī)藥產品。
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