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临床监查员

1.2-1.5万
  • 苏州相城区
  • 1-3年
  • 本科
  • 全职
  • 招1人

职位描述

医疗器械监查
  • 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 Teams
    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.
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工作地点

苏州相城区Yes!街南区

职位发布者

杨光/人事经理

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公司Logo爱恩康临床医学研究(北京)有限公司
At ICON we believe that our people are the most important asset. It is they who have helped to make ICON the success it is. Their commitment to clients, quality and delivery has earned ICON its enviable reputation. About DOCS: DOCS- ICON Resourcing Solutions is a division of ICON plc that provides global staffing solutions to Pharmaceutical, Biotechnology, Medical Device companies and CROs in over 39 countries. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. ICON has been in APAC since 1996 and the DOCS division of ICON is now expanding in the APAC region. Our Services: We are a specialist recruitment division focusing in Clinical Research, Medical Affairs, Regulatory Affairs, Drug Safety, Health Economics, Data Management& Statistics, Quality Assurance etc. Our full-spectrum resourcing solutions extend from contingent staffing, to functional resourcing, large-scale FSP and executive search. In addition, DOCS has developed a tailored training division‘CRAcademy’ to provide Traineeships and Training. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. Our History: DOCS was formed in The Netherlands in 1997 and grew to become the premier resourcing provider to the European pharmaceutical industry. The company was acquired by ICON plc in 2007 and was merged with ICON’s existing resourcing division, ICON Contracting Solutions. The merged company is now known as DOCS, and offers clients over 15 years of experience in the provision of global resourcing solutions. For more information, please visit www.docsglobal.com& www.iconplc.com.
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