Covance

  • Start-up Specialist I

    Job Location(s) US-NC-Raleigh-Durham | US-TN-Nashville | US-NJ-Princeton
    Job Number
    2018-22429
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Start-up Specialist

     

    Job Summary

     

    A career at Covance provides our employees the unique chance to create an immediate impact and difference in our patient’s lives. Joining Covance will offer a rewarding career, an opportunity to work in a high-energy & collaborative work place, along with access to comprehensive benefits. As an employee your work will be meaningful, the patient outcomes are real, and the results are lasting. Our mission is to help our clients bring the miracles of medicine to market sooner.

     

    We are currently hiring Start-up Specialists at our Wilmington, NC, Princeton, NJ and Nashville, TN facilities.

     

    The Study Start-up Specialist I will provide local support for clinical trial supply coordination.  This position will ensure documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.

     

    This is your opportunity to have an exciting career while making a difference in people’s lives.

     

    Essential Job Duties

    • Collect, review, process, and track regulatory & investigator documents required for effective and
    • compliant study site activation
    • Ensure that all assigned start up activities are on track and support study deliverables
    • Proactively manage sites to ensure timely site activation
    • Escalate study issues appropriately and in a timely fashion
    • Provide accurate projections and timelines to study teams agreed with Sponsor
    • Review and customize country and site specific patient informed consent forms for compliance
    • with local requirements and per protocol
    • Review and update study documents when there are changes in study personnel/study amendments
    • Liaise with Covance Regulatory department regarding document submission requirements
    • Prepare submissions to IRB/IEC, and regulatory authorities if GRS requires input
    • Negotiate site contracts and budgets with sites
    • Proactively track progress of contract and budget milestones/developments, intervening and
    • escalating as appropriate

    Education/Qualifications

    • University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
    • 2 years’ work experience in clinical research
    • In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 4 years work experience in clinical research

    Experience

    • Minimum of 2 years of experience in clinical development or regulatory process
    • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines
    • Familiarity with investigator start-up documents and contract/budgets negotiation process
    • Demonstrated understanding of research protocol requirements and proven ability to communicate

     

    Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Tell Us About Yourself

    Not ready to apply? Connect with us to join our talent community.