Description

Under the direction of the Director of the Office of Research Policies, Compliance and Committees, serves as a regulatory expert and coordinates activities directly related to research compliance.

1. Responsible for the comprehensive analysis of human and animal research protocols, and conflict of interest certifications and disclosures.
2. 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.
3. Works with researchers, staff and others to gather additional data when needed, may provide advice to researchers regarding submission problems and suggest solutions.
4. Coordinates committee meetings and assigns faculty reviewers with applicable expertise, drafts official committee correspondence and meeting notes.
5. Investigate concerns of potential regulatory noncompliance in accordance with scope set by regulatory committee, drafts investigation reports and submits to the committee for appropriate action.
6. Ensure federally mandated records are maintained; reviews and approves administrative modifications to procedures.
7. Provide regulatory and compliance education and training to faculty, staff, students and committee members.
8. Serve as the primary contact for regulatory audits and program/facility inspections.
9. Compose reports to agencies and accreditation for Institutional Official review.
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

EEO/AA

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.

Qualifications

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.

- Department is willing to accept education in lieu of experience.
- Department is willing to accept experience in lieu of education.