Covance

  • Start-up Associate

    Job Location(s) UK-Leeds
    Job Number
    2018-26616
    Job Category
    Hidden (54293)
    Position Type
    Full-Time
  • Job Overview

    COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We have an exciting opportunity available to join our team.


    We are currently recruiting Site start up Associate to join the Clinical Operations in Leeds, UK. We are looking for candidates experienced within: administration, clinical submissions, budget, contract negotiations.

     

    This is a full time permanent position.

     

     

    About the Job:

     

    • Primary contact and liaison with investigative sites during study maintenance and, site start-up activities
    • Ensure documents are filed and systems are updated on an ongoing and timely basis 
    • 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

    • University/College degree (life science preffered), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursuring certification, medical or laboratory technology)

    Experience

    • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines
    • Demonstrated basic understanding of the clinical trial process

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