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    更新于 12月7日

    臨床監(jiān)查員CRAI/II-外派外資藥廠

    1.3萬-1.8萬
    • 北京通州區(qū)
    • 1-3年
    • 本科
    • 全職
    • 招10人

    職位描述

    Ⅲ期藥品臨床監(jiān)查新藥化學(xué)藥Ⅱ期

    職責(zé)要求:



    • Drive study 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 Team as
      appropriate.

    • Contribute to the selection of potential sites
      and 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 Team Lead and QA.



    • Additional tasks assigned by manager, include but
      not limited: study level tasks associated with Country Study Manager
      (CSM), act as a mentor for junior team member, co-monitor less experience
      CRA within study team.

    • Contribute to process improvements, knowledge
      transfer and best practice sharing.



    任職資格:


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


    · Minimum 3-year experience as CRA or other related fields.


    · Have proven track record on performance of site management
    and monitoring delivery.


    · Solid understanding of the clinical dataflow


    · Excellent 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.


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


    · Demonstrates ability to prepare and deliver study related training
    materials


    · Ability to look for and champion more efficient and effective methods/processes
    of delivering quality clinical trials with reduced budget and in less time.


    · Very good written and verbal communication skills, negotiation,
    collaboration and interpersonal skills.

    工作地點(diǎn)

    信創(chuàng)園B區(qū)4號樓

    職位發(fā)布者

    顧意蓉/高級人力資源專員

    立即溝通
    公司Logo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。通過嚴(yán)格的質(zhì)量控制體系和專業(yè)團(tuán)隊的豐富經(jīng)驗,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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