Covance

  • Start-up Associate

    Job Location(s) US-NJ-Princeton
    Job Number
    2018-18629
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

     

     

    Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

     

    We have job openings for Study Start-up Associates at our Princeto, NJ facility!

     

    The Study Start-up Associate will be the primary contact and liaison with investigative sites during study maintenance and (when assigned) during site start-up (SSU).

     

    Responsibilities associated with this position:

     

    • Collect required investigator and regulatory documents to ensure EC applications are made within the timelines agreed with project management and SU team
    • Ensure documents are filed and systems are updated on an ongoing 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
    • Follow up with sites in order to ensure documents required are collected in a timely manner
    • Update study documents when there are changes in study personnel/study amendments
    • Contribute to the preparation of submissions to IRB/IEC
    • Ensure high quality site documents are filed in the TMF in a timely manner according to study
    • plans

     

    Covance believes that their best-in-class employees deserve first-class benefits. Covance offers an outstanding benefits package including medical & dental insurance, tuition reimbursement, a 401(k) plan with a generous company match, short and long-term disability, and life insurance.

     

    At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

    Education/Qualifications

    • University/College degree preferred
    • Certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) in lieu of degree

    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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