PRAHS

  • Trial Master File Associate - Lenexa

    Job Locations (All) | US-KS-Lenexa
    Posted Date 2 months ago(1/24/2019 1:52 PM)
    ID
    2018-50581
  • 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 Associate (TMFA) is responsible for supporting the life-cycle management and associated processes (from study set up to archiving) of the documents contained in the Trial Master File system.  Strong organizational and time management skills are needed as you will be performing multiple tasks in maintenance of the TMF.

     

    Additionally:

    • Logs information into an internal tracking system;
    • Scans documentation to the correct location in an electronic repository;
    • Sets up the Trial Master File (TMF) per client-approved specifications and PRA standards;
    • Maintains files in regard to upkeep of the study folders, application of study-specific labels, and assessment of supply needs for each aligned project;
    • Reviews electronic and paper documents for key attributes in a timely manner;
    • Reviews the electronic and paper TMF for completeness and basic content compliance and records findings;
    • Runs reports to ensure accuracy of the files;
    • Prepares the TMF for delivery at study closeout;
    • Reviews and prepares the TMF for audits and TMF reviews;
    • Helps resolves any internal quality control findings and audit findings;
    • Creates checklists and daily quality control schedules;
    • Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance.

    Qualifications

    What You Need to Have:

    • High school diploma or G.E.D., some college coursework 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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