Associate Director Of Regulatory Services

Profile

Associate Director of Regulatory Services
Duties: Provide outstanding service to meet the needs of all university constituencies involved with regulated research to ensure compliance with federal, state, and local regulations and policies. This position will assist the Director of Regulatory Services with implementation and maintenance of a comprehensive research compliance program that includes training and outreach, policy and procedure development, monitoring, reporting, and enforcement. Primary compliance areas included are human subject research, animal research, conflict of interest, export control, research integrity, and research misconduct. Proactively collaborates with senior administration and research community regarding compliance risks, controls, and new developments in research-related laws and regulations. Assists faculty, staff, students, and committees in interpreting federal regulations, national best practices, UTA policies/procedures, and UT System policies. Provides day-to-day supervision of Regulatory Services staff including hiring, orientation of staff, delegation of responsibilities, evaluation of staff, monitoring time, performance and salary actions, and dealing with problems. Assists staff in discharging their responsibilities and provides appropriate training, mentoring, and guidance. Directs the preparation and submission of divisional administrative reporting requirements such as the Unit Effectiveness Process and Business Continuity Plan. Frequently engages with other University Departments regarding financial and administrative matters. Assists with preparation and monitoring of the Regulatory Services budget. Primary oversight human research protection program: operations of the Institutional Review Board (IRB), review of research in accordance with regulations/internal SOPs, FDA IND/IDE evaluations, author and implement policies & procedures, reporting, reliance agreements, coordination with relevant UTA departments, non-compliance investigations, research monitoring, facilitating agency/sponsor audits, leadership and coordination of regional IRB working group, recordkeeping. Primary responsibility to maintain the office’s existing outreach and training programs and initiation and/or expansion of comprehensive campus-wide training and outreach for research COI, export control, research integrity, and related control measures for foreign influence. Assist in oversight of animal research program & recombinant DNA research: operations of the Institutional Animal Care & Use Committee (IACUC) & the Institutional Biosafety Committee (IBC), implement policies & procedures, reporting, coordination with Animal Facility or other relevant departments, non-compliance investigations, post-approval monitoring, maintain accreditation. Assist in oversight of export control program: develop & monitor Technology Control Plans, export licenses, implement policies & procedures, reporting, coordinate with relevant UTA departments, expand campus-wide training & outreach, monitoring, non-compliance investigations, identify sensitive high-risk activities for export assessment. Assist in oversight of research conflict of interest (COI) program: operations of the Research COI Committee, development & monitoring of Management Plans, review COI disclosures, implement policies & procedures, reporting, coordination with relevant UTA departments. Assist with research integrity matters: ensure compliance with sponsor/agency training requirements for responsible conduct of research (RCR), facilitate misconduct inquiries and investigations, ensure cross-coordination between areas of research ethics/compliance and relevant UTA departments, federal/sponsor reporting.

Company info

Sign Up Now - MiamiCrossing.com