Assistant Director, Research Administration
About The Position
Reviews international human subjects research protocols to ensure compliance with institutional, federal, and host-country ethical and regulatory requirements. Provides guidance and direction to researchers on obtaining in-country Institutional Review Board (IRB) or Ethics Committee (EC) approval when required. Ensures timely completion of international ancillary review. Maintains SOPs regarding ancillary review. Follows national standards in transnational research by engaging in benchmarking as well as keeping up with the best practices. Reliance between institutions when UF is ceding review, and when UF is serving as the IRB of record. Developing and maintaining SOPs, following national trends in reliance, including benchmarking. Assists in policies and procedures regarding reliance. Works on improving efficiencies in relance processes. HRPP Duties: Assist with Quality Improvement designed to improve effectiveness and efficiency of the IRBs/HRPP Serves as the lead on developing and implementing SOPs in the audit of the IRBs Serves as the lead on AAHRPP reaccreditation. Assists in analysis of policy and procedure gap to ensure best practices. Support addressing compliance-related inquiries and provide expert guidance and interpretation of applicable regulatory and institutional requirements. Supervising Research Regulatory Analyst III (full board coordinator), along with 2 editors and a senior secretary, and an OPS employee. Responsible for full board operations. Other duties as assigned.
Requirements
- Master’s degree in an appropriate area and two years of relevant experience; or a bachelor’s degree in an appropriate area and four years of relevant experience.
Responsibilities
- Reviews international human subjects research protocols to ensure compliance with institutional, federal, and host-country ethical and regulatory requirements.
- Provides guidance and direction to researchers on obtaining in-country Institutional Review Board (IRB) or Ethics Committee (EC) approval when required.
- Ensures timely completion of international ancillary review.
- Maintains SOPs regarding ancillary review.
- Follows national standards in transnational research by engaging in benchmarking as well as keeping up with the best practices.
- Reliance between institutions when UF is ceding review, and when UF is serving as the IRB of record.
- Developing and maintaining SOPs, following national trends in reliance, including benchmarking.
- Assists in policies and procedures regarding reliance.
- Works on improving efficiencies in relance processes.
- Assist with Quality Improvement designed to improve effectiveness and efficiency of the IRBs/HRPP
- Serves as the lead on developing and implementing SOPs in the audit of the IRBs
- Serves as the lead on AAHRPP reaccreditation.
- Assists in analysis of policy and procedure gap to ensure best practices.
- Support addressing compliance-related inquiries and provide expert guidance and interpretation of applicable regulatory and institutional requirements.
- Supervising Research Regulatory Analyst III (full board coordinator), along with 2 editors and a senior secretary, and an OPS employee.
- Responsible for full board operations.
- Other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
5,001-10,000 employees
