Research Compliance Analyst - (STA006494)
Under the direction of the IRB Associate Director in the Research Integrity and Oversight Office, serves as a regulatory expert and coordinates activities directly related to research compliance.
- Responsible for the comprehensive analysis of human and animal
research protocols, and conflict of interest certifications and
- Review human/animal research submissions, and/or conflict of
interest documentation for completeness and initial regulatory
review categorization and compliance prior to regulatory committee
(Institutional Review Board (IRB), Institutional Animal Care and
Use Committee (IACUC), Conflict of Interest (COI) review.
- Works with researchers, staff and others to gather additional
data when needed, may provide advice to researchers regarding
submission problems and suggest solutions.
- Coordinates committee meetings and assigns faculty reviewers
with applicable expertise, drafts official committee correspondence
and meeting notes.
- Investigate concerns of potential regulatory noncompliance in
accordance with scope set by regulatory committee, drafts
investigation reports and submits to the committee for appropriate
- Ensure federally mandated records are maintained; reviews and
approves administrative modifications to procedures.
- Provide regulatory and compliance education and training to
faculty, staff, students and committee members.
- Serve as the primary contact for regulatory audits and
- Compose reports to agencies and accreditation for Institutional
- Provide assistance with implementation and problem-solving
related to online compliance submission system Collaborate with
university committee members and groups to ensure research
approval. Performs other job-related duties as assigned
Bachelor's Degree 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.
This position will directly and fully coordinator the daily operation of one of the three UH Institutional Review Boards. The ideal candidate will have at least 3 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 and other Responsible Conduct of Research (RCR) areas.
Certified IRB Professional (CIP) certification preferred.
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