Covance

  • Clinical Trial Coordinator

    Job Location(s) US-NJ-Newark
    Job Number
    2018-25965
    Job Category
    Clinical Trial Support
    Position Type
    Full-Time
  • Job Overview

    Discover new opportunities to grow your career at Covance FSPx

     

    Clinical Trial Coordinator

    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 a Clinical Trial Coordinator to be office based in Rahway, NJ!

     

    The Clinical Trial Coordinator will support tasks associated with study start-up.

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

     

    Essential Job Duties

     

    Additional Job Responsibilities include:

    • Develop project specific plans for the GSS component of assigned studies
    • Liaise with operational project team regarding project issues (i.e., participate in team meetings)
    • Collect, review, approve process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan
    • Review and approve patient informed consents for compliance per protocol
    • Assess impact of changes in study personnel and document amendments on regulatory documents (including Informed Consent)
    • Prepare new investigator submission packages to Local and Central IRB / IEC
    • Provide milestone information for incorporation into weekly analysis sheets
    • Monitor performance of GSS team with regard to project timelines
    • Manage the drug supply vendor activities as applicable
    • Independently research and evaluate proposal request from clients in all therapeutic areas within agreed timeframes
    • Assume responsibility for the preparation and dissemination of documents according to the feasibility processes in place
    • Create surveys to probe “thought leaders,” experienced researchers, and clinicians in the field
    • Conduct follow-up calls with Investigators and/or Study Coordinators to solicit in-depth information related to feasibility, and obtain further detailed information regarding potential proposals
    • Conduct QC of feasibility documents as required by the process
    • Directly manage day to day conduct with clients for stand-alone feasibility activities and other feasibility activities 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, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations

    Experience

    • In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered
    • Ability to drive and possess a valid driver’s license
    • Ability and willingness to present at internal and external meetings
    • Less than 10% travel may be required both international and domestic

    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.

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