• Regulatory Specialist II

    Requisition Number 2019-1533
    Department Research Protections Department
  • Responsibilities

    This position is responsible for providing substantive regulatory, administrative, and analytical support to one or more of the following research protections committees: the Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), and/or 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. 

    General responsibilities/qualifications in support of each committee:
    • Regulatory analysis of research protocols being submitted to the IRB/IBC/IACUC for review; whether in paper or through the electronic regulatory software, eProtocol.
    • Direct support of Board/Committee Members including, but not limited to: training, voting member education program, interactions with and support of the Chairman of the Board/Committee. 
    • Compose complex, technical, detailed minutes for IRB/IBC/IACUC meetings and other Board related items (e.g. result/approval letters, etc.) to researchers and regulators.
    • Contribute to the development and implementation of committee policies, procedures, and training materials for staff and committee members.
    • Continual development and improvement of IRB/IBC/IACUC internal processes and complete miscellaneous projects related to the eProtocol software system.
    • Superior organizational, analytical, critical thinking, multi-tasking abilities.
    • Strong, effective, interpersonal communication skills; with an ability to employ tactful diplomacy in interactions with diverse co-workers and investigative staff on behalf of each committee.


    IRB focused role:  
    • Should have strong familiarity with all federal regulations surrounding Non-Exempt Human Subject Research [e.g. 45 CFR 46, 21 CFR parts 50, 54 and 56].
    • Assist with the Clinical Research Program (CRP) feasibility reviews prior to IRB submission.
    • Lend guidance to researchers in creating/modifying protocols and consent forms utilizing the eProtocol regulatory software.
    • CIP certification strongly desired if primary support is for the IRB.


    IACUC focused role:
    • Should have familiarity with regulations and guidance such as the PHS Policy on Humane Care and Use of Laboratory Animals, The Guide for the Care and Use of Laboratory Animals, and Animal Welfare Regulations where appropriate.
    • Knowledgeable in laboratory research using animal models and can read/understand basic level of protocols.
    • Ability to provide technical advice to PIs on IACUC submissions/protocols.
    • May be asked to assist in inspections of animal facilities and research laboratories. Able to support/promote the overall function and visibility of the IACUC at BRI (e.g. training, post approval monitoring, online guidance, maintenance of inter-institutional agreements, etc.) in conjunction with recommendations from the IACUC
     

    IBC focused role:
    • Should have familiarity with NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
    • Ideally a scientific background and subject matter expert in Research Involving Recombinant DNA Molecules, and infections organisms.
    • Ability to provide technical advice to PIs and the IBC on research safety procedures.
    • May be asked to serve as a voting member on the IBC, in additional to function in an administrative capacity.
    • Assist in the development of a program to promote safe microbiological practices, procedures, and proper use of containment equipment and facilities.
    • Assist BRI Occupational Health in ensuring laboratory standards are being followed, and report to the IBC any areas of concern, violations, accidents, etc.
    • Able to work in a collaborative manner with the Safety Department to provide advice (e.g. lab setup, training, security, etc.) in conjunction with recommendations from the IBC.

    Requires a B.S. or B.A. and either 4-5 years IRB/IBC/IACUC experience or other relevant regulatory experience.  May substitute college degree with a high school degree PLUS a total of 6+ years relevant work experience depending on role within the department.

    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 occasionally make decisions, work effectively on a team, mentor new staff on occasion, may need to teach and make presentations to new Board members.  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 occasional 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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