The Human Subjects Protection Program (HSPP) at the University of Arizona seeks to fill the position of Assistant Director. The Assistant Director, in coordination with the Director, is responsible for the oversight and daily management of the HSPP staff including staff supervision, training and development; triage of project submissions; dissemination and implementation of policies and procedures; tracking and reporting of data and metrics; and providing training and guidance to the IRB and University researchers. This position works closely with other UA compliance offices, University research departments and administration, and academic healthcare partners. The UA HSPP program has been accredited by the Association for Accreditation of Human Research Protection Programs (AAHRPP) since 2005.
The Human Subjects Protection Program conducts review and approval for all human research conducted at the University of Arizona and affiliated health care partners. Specific duties include:
• Manage and monitor workflow of submission and entry into the electronic IRB system to ensure continued efficiencies, including triaging tasks dependent upon volume and priority.• Ensure consistency among the HSPP staff, IRB Committees, and HSPPpolicies and procedures.• Respond to researcher and IRB requests for clarification and guidance regarding ethical issues in biomedical and behavioral research involving human subjects.• Serve as primary reviewer for difficult or time sensitive items (e.g. JITrequests) requiring a higher level of understanding of the federal regulations and University policy.• Serve as the liaison with other institutions seeking single IRB review, which includes coordination of required paperwork for the Institutional Official and management of other submission systems. • Maintain knowledge of existing affiliation agreements, contracts, and memorandum of understandings that affect local context considerations and reporting requirements.• Maintain all records necessary to demonstrate regulatory compliance and to maintain AAHRPP accreditation. • Assist with the preparation of the AAHRPP accreditation report.• Track and present data and metrics.• Develop and maintain documents and tracking system for the External Exempt Review Committee.• Identify educational needs and provide educational training sessions across the institution and with academic partners in coordination with the Education and Training Coordinator.• Assist with compliance investigations and prepare summary reports.• Design and conduct internal assessments and other quality improvement activities to improve the efficiency and effectiveness of the Human Research Protection Program to ensure adherence to Federal and local regulations, policies and standard operating procedures as identified by the Director and the Quality Assurance Officer.• Serves as point of contact for external audits and dedicate HSPP resources as needed to support regulatory compliance.• Identify process improvement opportunities and minimize burden on the research community while maintaining high standards of compliance in collaboration with the Business Analyst for Research Compliance.• Establish and maintain positive and productive working relationships with the research community by collaborating with research teams in order to streamline IRB applications and produce high quality research.• Serve as mentor and trainer of the HSPP staff. • Serve in the capacity of Acting Director when the Director is absent.• Assist Director with requirements of the ESCRO committee.• Other duties as assigned.
• Expertise in regulations pertaining to the protection of human subjects, including OHRP, FDA, and AAHRPP standards• Experience directly working with regulatory committees or other institutional research experience as appropriate• Supervisory experience
• Bachelor’s degree in an appropriate field.• Three years of progressively responsible experience in human subjects regulations and administration with at least one year in a supervisory capacity.• Current Certified IRB Professional (CIP) certification or ability to obtain CIPwithin one year.• Demonstrable success in the supervision and development of administrative staff Excellent verbal and written communication skills.• Excellent interpersonal and collaborative skills, along with the ability to interact effectively with a diverse constituency.• Demonstrated organizational and prioritization skills, along with the ability to work within tight and conflicting deadlines.• Demonstrated ability to be detailed oriented.• Demonstrated ability to think quickly and effectively.