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    400-885-9898
    更新于 12月13日
    智聯(lián)APPAPP
    舉報
    臨床監(jiān)查員CRA
    1.3萬-2.2萬·13薪
    • 上海浦東新區(qū)
    • 經(jīng)驗不限
    • 本科
    • 全職
    • 招5人
    職位描述
    Ⅰ期Ⅱ期Ⅲ期Ⅳ期藥品臨床監(jiān)查新藥化學(xué)藥生物藥
    Duties and Responsibilities (including but not limited to):
        
    1. Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.
      2.   
    2. Conduct study feasibility and site selection activities
      3.   
    3. Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
      4.   
    4. Assist with investigator meeting activities including organization, preparation and attendance
      5.   
    5. Conduct site management activities including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.
      6.   
    6. Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
      7.   
    7. Establish and maintain good rapport with study sites.
      8.   
    8. Write study visits reports and follow up letters within the timeline established by applicable SOPs and guidelines
      9.   
    9. Representation of CRAs during an audit or inspection when assigned
      10.   
    10. Coordinate timely shipment of clinical supplies and study drug to sites.
      11.   
    11. Ensure proper storage, dispensation and accountability of clinical supplies and study drug.
      12.   
    12. Maintain adequate site tracking records
      13.   
    13. Follow up of drug safety issues and safety reports in timely manner, if applicable
      14.   
    14. Communicate site study issues, concerns, and progress to Project Manager, Clinical Team Lead and Clinical Research Manager accordingly
      15.   
    15. Develop and implementation of corrective actions when appropriate
      16.   
    16. Assist with data query form (incl. query process)
      17.   
    17. Prepare /review all patients tracking records
      18.   
    18. Input and maintain study information concerning subject status of financial reimbursement to sites.
      19.   
    19. Conduct and assist with administrative activities as a member of the project team.

    Education and Work Experience:
        
    1. Bachelor’s Degree in allied health fields: Medical, Nursing, Pharmacy, Psychology, Veterinary or Health Science
      2.   
    2. Minimum of 1 year experience as a Clinical Research Associate
    Knowledge, Skills, and Abilities:
        
    1. Excellent verbal and written communication skills
      2.   
    2. Good verbal and written English language skills
      3.   
    3. Strong computer literacy e.g. MS word, Excel, PowerPoint, internet
      4.   
    4. Excellent organizational, record retention, and time management skills
      5.   
    5. Knowledge of ICH-GCP, applicable law (local and country) and regulatory requirements
    工作地點(diǎn)
    浦東新區(qū)
     
     
    職位發(fā)布者
    曾女士/招聘
    立即溝通 
    公司Logo愛恩康臨床醫(yī)學(xué)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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