• IRB Specialist

    Posted Date 4 weeks ago(9/20/2018 8:10 AM)
    Job ID
    2018-3198
    # of Openings
    1
    Job Location(s)
    US-MD-Bethesda
    Category
    Research
  • 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.

     

    We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

     

    Duties & Responsibilities

    Medical Science & Computing is searching for an IRB Specialist to support the National Institutes of Health (NIH). This opportunity is full-time, and it is on site in Bethesda, MD. 

    • Coordinates and prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local SOPs and federal regulations.
    • Assists with the management, administration, and coordination of IRB operations and activities
    • Serves a resource to clinical branches for information and guidance on regulatory, policy, and procedural requirements and on the complex preparation and submission of clinical protocols and related actions (e.g., continuing reviews, amendments, etc.) for review.
    • Reviews protocol actions (new requests, responses to stipulations, amendments, continuing reviews, closures, etc.) prior to submission to the IRB for compliance with regulatory, policy, and procedural requirements and for completeness, appropriateness, and adequacy of information (e.g., ensuring adequate detail for review, ensuring required elements have been addressed). 
    • Applies knowledge of regulations and policies to identify components of protocol requests that need additional information or correction and works closely with Principal Investigators and other appropriate staff to advise them of complex regulatory, ethical, and procedural requirements that must be met before final approval of the protocol is granted. 
    • Coordinates IRB meetings by performing such duties as scheduling presentations by Principal Investigators who have actions submitted for review; monitoring maintenance of quorum; monitoring and advising on which members cannot be present based on conflicts of interest; reviewing meeting minutes for technical accuracy; and following-up on recommendations, decisions, and action items.

    Requirements

    • BS degree in Biomedical Sciences or related discipline; MS or MPH preferred
    • Demonstrated experience supporting IRB operations and activities
    • Demonstrated experience supporting all aspects of clinical research
    • Knowledge of policies and regulations pertaining to IRB submissions
    • Experience working with protocols to include review for compliance, completeness and accuracy
    • Experience writing and reviewing protocols, managing IRB submissions, database management, monitoring study records
    • Prior FDA experience preferred

     

    Medical Science & Computing is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

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