• Regulatory Specialist I

    Requisition Number 2019-1532
    Department Research Protections Department
  • Responsibilities

    This position is primarily responsible for reviewing research from investigators submitting applications to one or more of the compliance committees managed by the Research Protections Department.  These committees include the Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), and Institutional Animal Care and Use Committee (IACUC).  Activities must be carried out in compliance with all applicable federal and state regulations for protection of Human Research Subjects, institutional oversight of recombinant DNA research, and laws applicable to the use of animals in research.  This includes all applicable local institutional polices that govern each activity. 

    Specific responsibilities may include but are not limited to:
    • Coordinate, review, and manage submissions to a specified compliance committee, based on regulatory experience.  Provide assistance to other committees as needed.
    • Tracking of training required for the IRB/IBC/IACUC Key Personnel as applicable.  (e.g. Ethics, GCP, various IBC and ACUC training)
    • Compose complex, detailed minutes for IRB/IBC/IACUC and other Board related items as needed.
    • Write letters and correspondence to researchers relaying specific IRB/IBC/IACUC Board requests with regular and timely follow-up.
    • Continual development and improvement of IRB/IBC/IACUC internal processes; specifically, the new eProtocol regulatory software.
    • Handle researcher questions/requests and lend guidance on all IRB/IBC/IACUC functions.

    Requirements

    • Strong organizational, analytical, critical thinking, multi-tasking abilities, with proven customer service experience. 
    • Ability to write clear, detailed technical correspondence.
    • Must be able to work within a deadline-driven environment.
    • Must be able to navigate and provide direct support for all functions of the RPD regulatory software.

    Requires a B.S. or B.A. and either 2-3 years IRB/IBC/ACUC experience or other research experience (e.g. grants).  May substitute college degree with a high school degree PLUS a total of 5 years relevant work experience.  Should be able to demonstrate direct regulatory committee knowledge. CIP certification desirable. 

    Mental Requirements:
    Requires the continuous need to read, write, speak and understand English.  In addition, the incumbent must continuously utilize strong interpersonal skills with others both inside and outside of the organization.  This position must be able to make decisions, work effectively on a team, and potentially mentor new staff on occasion.  In addition, the incumbent must be able to analyze and resolve problems both with and without the input of others depending on the complexity of the problem. 

    Physical Requirements: 
    This position requires frequent walking and grasping of objects.  The incumbent must continuously be able to sit, hear and do repetitive motions with both the hands and wrists. In addition this position requires the ability to talk, reach and handle objects pertaining to the work.  Must be able to lift up to 20 pounds.  On a rare occasion the incumbent must be able to push, pull or carry up to 20 pounds.

    Working Conditions:
    Work is normally performed during daytime hours in an office setting.  Much of the work involves close-up CRT/computer use.  Individual may work in close quarters with others.

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