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Research Compliance Specialist
2 months ago
Wayne State University is seeking a highly skilled Research Compliance Administrator to join its team. As a key member of the Division of Research, this role will play a critical part in ensuring the university's research activities are conducted in accordance with federal, state, and local regulations.
Key Responsibilities:- Coordinate the administration of the Institutional Review Board (IRB), Animal Investigation Committee (AIC), and other regulatory activities and operational procedures involved with reviewing and approving research protocols.
- Function as a liaison for multiple review boards, investigators, granting agencies, and federal regulatory agencies.
- Review and process new and continuing research protocols for submission to appropriate research review boards.
- Resolve protocol submission errors/problems with investigators and key personnel.
- Coordinate and attend IRB/committee meetings.
- Assist faculty and research investigators with compliance and regulatory issues.
- Review adverse events and protocol violations and direct to committee chair, individual IRB, institutional officials, and regulatory agencies as appropriate.
- Conduct, monitor, and coordinate special projects as assigned.
- Graduation from an accredited college or university supplemented by coursework in research, business administration, or related field.
- Reasonable knowledge of pertinent federal regulators and state and local laws.
- Some knowledge and experience with University policies, procedures, and practices surrounding the approval of research.
- Some knowledge of pharmaceutical and drug agency research requirements.
- Reasonable knowledge of and experience with PC and computer-based applications.
- Some supervisory experience required.
- Ability to communicate effectively with others.
- Strong analytical and problem-solving skills.
- Ability to establish and meet deadlines, work under extreme pressure, and function independently.
This position is located in a normal office environment.
Wayne State University is an affirmative action/equal opportunity employer and welcomes applications from women, people of color, and other underrepresented groups.