The Human Research Protection Program (HRPP) Administrator will manage the privileged and confidential institutional review and approval process of all proposed research activities involving human subjects to protect their safety, rights, and welfare. Under administrative direction, the HRPP Administrator will serve as a member, with vote, on the Institutional Review Board (IRB); perform highly complex duties to facilitate the review and approval process, such as use of independent judgment in interpreting and applying relevant federal and state laws, regulations, and institutional policies and guidelines; conduct literature reviews and prepare reports on scientific topics and on regulatory precedent and changes; instruct IRB chairs, members, and researchers on the regulations and ethical principles essential to the review process; provide training and advice to faculty, staff, and student researchers on the regulations and on preparation of applications and consent forms; and review and approve administrative and procedural modifications of applications. This position reports to the Director of Research Compliance.
Primary Duties and Responsibilities: oServes as a voting member of the IRB, and functions as a designated reviewer for exempt and expedited reviews. oInterpret and apply federal and state laws, regulations, institutional policies, and guidelines to protect human subjects and to ensure institutional compliance. oEnsures research activities are carried out in a manner that is compliant with all federal, state and local requirements by providing direction on promoting and maintaining required compliance. oProvide regulatory, ethical, and method advice to individual faculty, staff, and students in preparation of applications for research proposals involving human subjects and consent documents. oDraft correspondence that conveys IRB deliberations and contingencies for approval of research activities involving human subjects. oAssist in program development, implementation, and evaluation. oEstablish and maintain self as a professional expert and resource to the organization, patients, families and the Community. Participate in appropriate professional organizations and continuing education programs. oOther duties as assigned.
Bachelor’s Degree required. Minimum of 2 years in research administration, with experience directly related to human subjects research. Candidate must have excellent organizational and oral/written communication skills, familiarity with medical terminology, strong interpersonal, problem solving and collaboration skills, ability to interact professionally with MD’s and PHD’s, ability to maintain professional standards under routine conditions of demanding time constraints and proficient in MS Word, Excel, PowerPoint and Access.
Advanced degree and/or certified IRB Professional (CIP) preferred.
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