Covance

  • Start-up Associate

    Job Location(s) MX
    Job Number
    2018-20176
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    *** Position is located in Mexico City, Mexico ***

    Ensure documents are filed and systems are updated on an ongoing and timely basis making
    Covance ready for an audit at any time.
    Collect and track regulatory & investigator documents required for effective and compliant study
    site activation and maintenance.
    Ensure that all assigned maintenance and start up activities are on track and support study
    deliverables.
    Follow up with sites in order to ensure documents required are collected in a timely manner.
    Escalate study issues appropriately and in a timely fashion.
    Update study documents when there are changes in study personnel/study amendments.
    Contribute to the preparation of submissions to IRB/IEC with appropriate supervision.
    Ensure high quality site documents are filed in the TMF in a timely manner according to study
    plans.
    Undertake tasks delegated by senior team members, depending upon country and situational
    requirements with proper supervision.
    Perform other duties as assigned by management.

    Education/Qualifications

    Recommended: University/College degree (life-science preferred), or certification in a related allied health profession from an appropiate accredited institution (e.g., nursing certification, medical or laboratory technology). 

    Experience

    Minimum Required:
    Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
    Demonstrated basic understanding of the clinical trial process, familiarized with EC-MoH submission packages and related processes. 1 Year of experience in start-up postions is preferred.

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