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Research Compliance Specialist- IRB
4 months ago
Under the direction of the Director of the Office of Research Policies, Compliance and Committees, coordinates activities directly related to research compliance, the Committee for the Protection of Human Subjects (CPHS), and internally funded research programs.
* Serves as a regulatory expert in one or more Responsible Conduct of Research (RCR) areas, including but not limited to: research involving human subjects, animal care and use, conflict of interest, research integrity and/or grant congruency.
* Follows defined processes to ensure institutional and investigator compliance in one or more of these areas, including the coordination of review committee function and/or the conduct of pre- or post-approval monitoring of research.
* Develops and implements guidelines and application processes for the university research community, develops and delivers detailed training materials.
* Makes administrative regulatory determinations, and evaluates investigator response to committee contingencies.
* Serves as a resource for oversight committee members and other Division of Research offices.
* Reviews grant, contract, and internal award materials for congruency and/or compliance.
* Assists applicants in coordinating committee review processes related to funded research.
* Performs other job-related duties as assigned.
EEO/AA
Bachelors and 3 years experience
Requires a thorough understanding of both theoretical and practical aspects of an analytical, technical or professional discipline; or the basic knowledge of more than one professional discipline. Knowledge of the discipline is normally obtained through a formal, directly job-related 4 year degree from a college or university or an equivalent in-depth specialized training program that is directly related to the type of work being performed. Requires a minimum of three (3) years of directly job-related experience.
Additional Job Posting Information:
This position will directly and fully coordinate the daily operation of one of three UH Institutional Review Boards. The ideal candidate will have at least three years' experience in central institutional coordination of human subjects research (i.e. committee administration), working knowledge of federal (DHHS and FDA) regulatory requirements, and high-level written and oral communication skills. Strong organizational abilities and a customer service background in regulatory oversight is required, as is the ability to proficiently work within and run reports and metrics from an online protocol system. This position may also be assigned to conduct compliance investigations and/or perform post-approval monitoring of human subjects research.
Certified IRB Professional (CIP) certification preferred.
* Department is willing to accept education in lieu of experience.
* Department is willing to accept experience in lieu of education.