• Protocol Navigator

    Posted Date 2 months ago(8/9/2018 10:21 AM)
    Job ID
    2018-3096
    # of Openings
    2
    Job Location(s)
    US-MD-Bethesda
    Category
    Science
  • Overview

    Medical Science & Computing (MSC) is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

    MSC is currently searching for a Protocol Navigator to support the National Institutes of Health (NIH). This opportunity is full-time, and it is on site in Bethesda, MD.

    Duties & Responsibilities

    Initial Protocol/Consent Writing/Editing

    • Assist Principal Investigators (PI) with the writing/revision of clinical research protocols and informed consent forms (ICFs); completing standard wording for regulatory sections in new protocols using template language
    • Format documents
    • Ensure consistency within protocol and between protocol and ICF.

    Branch Review

    • Assist PIs with scheduling meeting and with distribution of documents prior to meeting.
    • Distribute appropriate forms for PI, Peer Reviewers. And Branch Chiefs to complete
    • Assist PIs in incorporating suggested changes and respond to reviewers’ comments.
    • Collecting all forms and PI responses to prepare a Branch Review packet.

    IRB actions and Protocol Administration

    • Prepare new protocol for Scientific Review and IRB submission
    • Resource Assessment Form (PRIA)
    • Travel Reimbursement Form (DRTS)
    • Ethics Clearance submission (DEC)
    • Radiation Safety Committee submission (RSC) (when applicable)
    • Recruitment Flyers
    • Prepare and submit continuing reviews (with assistance of research team and data managers), protocol amendments, various other IRB submissions in consultation with PI
    • Maintain Regulatory Binder
    • Update Protocol View

    Regulatory Services

    • Keep up with current regulations/guidance
    • Facilitate Pre-IND/IDE meetings (when applicable)
    • Prepare Initial IND/IDE Submission
    • Facilitate interactions with FDA Regulatory Managers (when applicable).
    • Prepare FDA annual reports and other submissions with assistance of research team and data managers (when applicable)

    DSMB reports

    • Draft reports with assistance of research team and Data Managers (when applicable)
    • Submit all docs prior to meeting
    • Assist in responding to stipulations (when applicable)

    Radiation Safety Committee (RSC) Actions

    • Prepare initial submission
    • Prepare triennial review submission

     

    Other tasks

    • Assist with MTA agreements
    • Assist with Reliance Agreement requests and submissions
    • Coordinate translations of consents and tracking number of short forms used.
    • Assist research team with monitoring visits in regards to the regulatory binder.

    Requirements

    • BS degree in Biomedical Sciences or related discipline; MS or MPH preferred
    • Demonstrated experience coordinating all aspects of clinical research
    • Experience writing and reviewing protocols, managing IRB submissions, database management, monitoring study records
    • Prior FDA experience preferred

    Options

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