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    更新于 9月9日

    臨床監查員 II(外派外資藥廠)

    1.3-1.5萬
    • 廣州越秀區
    • 1-3年
    • 本科
    • 全職
    • 招2人

    職位描述

    藥品臨床監查疫苗罕見病
    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

    廣州越秀區江灣商業中心

    職位發布者

    董雅喬/招聘經理

    昨日活躍
    立即溝通
    公司Logo上海康德弘翼醫學臨床研究有限公司
    康德弘翼(WuXi Clinical)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、醫療器械、體外診斷試劑等醫藥產品,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團隊的豐富經驗,幫助創新性,突破性醫藥產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、生物技術公司以及醫療器械公司。目前,公司實行全球聯合運營,人員規模達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務交流,保證了項目能高效、高質地完成。隨著業務能力和業務范圍的不斷拓展,康德弘翼進一步完善和增強了全球一體化研發服務平臺的綜合實力,助力全球創新合作伙伴更好、更快地開發醫藥產品。
    公司主頁
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