PRAHS

  • Trial Master File Coordinator

    Job Locations (All) | US-KS-Lenexa
    Posted Date 1 month ago(10/16/2018 6:57 PM)
    ID
    2018-49823
  • Overview

    Who We Are:

    We Are PRA.  We are 16,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.

     

    What is a TMF System:

    The Trial Master File (TMF) contains those essential documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced. The TMF is the evidence of GCP compliance and of the trial's scientific credibility.

    Responsibilities

    What You Will Be Doing:

    The Trial Master File Coordinator (TMFC) is responsible for the management and storage of the documents contained in the Trial Master File system.  Strong communication skills are needed as you will be liaising with internal and external customers to meet project specific goals for the TMF.

    Additionally:

    • Identifies out of scope tasks and determines associated effort and actions for complex project needs
    • Interacts with sponsors, PRA functional areas and if applicable, document management vendors, for project-related issues, needs and tasks
    • Configures checklists within the eTMF system to support the TMF Specifications and maintaining global level events
    • Coordinates TMF Reviews and facilitates accurate and timely completion of deficiencies
    • Participates in audits and presents on services related to functional area for assigned projects; coordinates and hosts sponsor on-site TMF reviews, if required.

    Qualifications

    What You Need to Have:

    • Undergraduate degree preferred
    • Proficient in Microsoft Office Products
    • Prior experience using computerized information systems
    • Proficient in developing project/process documents
    • Industry knowledge including ICH/GCP, local regulatory authority and clinical development questions.
    • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.



    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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