Regulatory Specialist I-II

Requisition Number 2020-1641
Department Research Protections Department

Overview

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. 

Responsibilities

Specific responsibilities may include but are not limited to:
• Screen and review IRB submissions to ensure they meet institutional and regulatory requirements.
• 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.
• Triage researcher questions/requests and lend guidance on all IRB/IBC/IACUC functions.
• Provide training support for all activities related to the IRB (e.g. IRB software, new board members, Coordinator, etc.)

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.

Regulatory Specialist I
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. 

Regulatory Specialist II
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. Should be able to demonstrate direct regulatory committee knowledge. CIP certification desirable. 

 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.

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