Covance

  • Clin Quality Control Assessor

    Job Location(s) CN-Beijing | CN-Shanghai
    Job Number
    2018-20472
    Job Category
    Quality Assurance
    Position Type
    Full-Time
  • Job Overview

    ¨ Conduct Clinical Quality Control (CQC) visits to ensure compliance to the requirements of the clinical study protocol, standard operating procedures (SOPs), ICH / GCP guidelines and
    relevant local, national and international legislation.

    o Principal Investigator (PI) oversight, Investigator audit / inspection readiness and
    adherence to the standards of ICH / GCP guidelines.
    o Clinical Research Associate (CRA) compliance with monitoring responsibilities as
    specified in Covance SOPs, study plans, and ICH / GCP guidelines.
    o Site compliance to the protocol to ensure the safety, rights and integrity of subjects is
    adequately protected.
    ¨ Prepare, conduct, report and follow up on the CQC visit according to established guidelines.
    ¨ Ensure that all pertinent issues identified during a CQC visit including but not limited to
    subject safety, PI oversight, CRA competency issues are escalated appropriately.
    ¨ Coordinate regional CQC visit conduct to ensure that country specific targets are met.
    ¨ Ensure that all issues identified within CQC visits are followed-up within the specified
    timeframe and learning’s are promptly communicated across functional teams.
    ¨ Contribute to Country specific quality plans and strategies to identify, address and resolve
    operational issues and ultimately demonstrate best in class standards.
    ¨ Coach and mentor members of the Clinical Operations function that either:
    o Have involvement within the conduct of CQC visits.
    o Are identified as requiring additional support.
    ¨ As required, conduct site monitoring and management responsibilities according to Covance Standard Operating Procedures (SOPs), ICH / GCP guidelines.

     

     

    Education/Qualifications

    ¨ University Bachelors degree in a medical or scientific discipline, or related field.
    ¨ Nursing qualification / certification may be considered in lieu of a University degree.

    Experience

    Minimum Required:
    ¨ Minimum of four years of clinical research site monitoring experience (including pre-study,
    site initiation, routine monitoring and close-out visits).
    ¨ Working knowledge of ICH / GCP guidelines and the pharmaceutical development process.
    ¨ Experience of supporting and formally / informally mentoring colleagues.
    ¨ Track record of meeting commitments and driving change, using a highly collaborative
    approach, and emphasising team success versus individual achievement.
    ¨ Advanced planning and organisational skills
    ¨ Previous Quality Control or Quality Assurance experience is preferred

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