PRAHS

  • Document Mgmt Associate- Home Based

    Job Locations - | US-PA
    Posted Date 6 days ago(6/12/2018 10:45 AM)
    ID
    2018-47428
  • Overview

    The Document Management Associate (DMA) (Levels 1 and 2)  is responsible for the receipt and accurate logging of all incoming study documentation, scanning documentation to the correct location in an electronic repository; setting up the Trial Master File (TMF) per the approved specifications; maintenance and accuracy of the files; delivery of the Trial Master File at study closeout; and the resolution of any internal quality control findings or external compliance audit findings.

    Level 3 Document Management Associates perform quality control reviews and tasks associated with non-standard client expectations , which include, but are not limited to, reconciliation of study documents, shipment of documents per client standards, and comparison of the electronic document repository to the paper TMF to ensure compliance of Document Management activities with regulatory requirements, PRA standard operating procedures, and client specifications. 

    Level 4 Document Management Associates provide supervisory oversight and training while contributing to key Document Management deliverables by organizing and executing tasks with the project team, management, and Document Management employees.

    Responsibilities

    • Complete understanding and application of PRA’s SOPs and systems (Sponsor systems where applicable).
    • Demonstrated ability to training and mentor multiple levels of staff.
    • Demonstrated clear and professional written and verbal communication skills.

    Qualifications

    • Prior experience in records management, office support or similar duties
    • Prior experience using computerized information systems
    • Prior industry experience
    • Prior experience in a leadership role
    • Prior accountability with vendors or clients
    • Read, write, and speak fluent English; fluent in host country language
    • Knowledge of ICH/GCP, local regulatory authority and clinical development regulations



    • Undergraduate degree (e.g. Associate’s or Bachelor’s) in a clinical, science or related field from an accredited institution



    • N/A





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

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