Human Research Protections Program Director

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Human Research Protections Program (HRPP) Director

University of Connecticut (UConn) Office of The Vice President for Research is seeking a knowledgeable, respected, goal-driven leader to join our team as a Human Research Protection Program (HRPP) Director.

Reporting to the Associate Vice President for Research Integrity, the successful candidate will have experience in providing direction and administrative oversight to all core components of the institution's HRPP which supports activities of UConn IRBs, compliance unit (including oversight of compliance with clinical trial registration and reporting requirements), education unit (human research protection, good clinical practice, and responsible conduct of research), reliance functions, and Quality Assurance and Improvement.

The HRPP Director will oversee the facilitation and support of research reviewed by the Institutional Review Boards (IRBs), including the development and implementation of program goals and objectives.

Specific duties and responsibilities include :

• Provide direction and integrative coordination in the planning, development and implementation of the HRPP.
• Serve as the Deputy HIPAA Privacy Officer for matters related to Human Subjects Research.
• Establish and implement short-and long-range goals, objectives, policies and operating procedures; monitor and evaluate operational effectiveness and affect changes required for improvement.
• Serve as principal point of collaboration, leadership, and expertise to both internal constituencies (Conflicts of Interest (COI) Responsible Conduct for Research (RCR) Radiation Safety, eSCRO, etc) and external constituencies on professional and operational matters pertaining to the HRPP.
• Supervise IRB staff, set priorities and functional standards, giving direction to staff as necessary to ensure the best possible delivery of service and high customer satisfaction.
• Maintain a current knowledge of Federal, State, and local laws, regulations, policies and guidelines governing human subject research;

participate in and provide education and training.

• Interpret and apply federal, state and local regulations, policies and procedures related to research involving human participants.
• Work closely with Institutional leadership, (Office of the General Counsel, Office of University Compliance Office of Healthcare Compliance & Privacy), to ensure compliance with the ethical and regulatory requirements for human subjects research.
• Develop and maintain positive relationships with collaborating organizations.
• Act as liaison with federal and state agencies on human research issues.
• Manage the AAHRPP accreditation process under the direction of the AVP, including revisions to policies, procedures, and other documents necessary to support the reaccreditation process.
• Design, implement, and evaluate organizational and staffing models to effectively accomplish the goals and objectives of the HRPP.
• Design, develop, implement, evaluate, and modify technical and administrative IRB review processes and internal research auditing policies, protocols, systems, and procedures.
• Work with appropriate internal resources to analyze data and prepare and present IRB audit reports and summaries, and provide feedback to the Institutional Official / Designee, researchers and the IRB as appropriate.
• Identify educational needs of researchers, based on audit data and other information; oversee the development and delivery of targeted training programs and materials based on IRB review and audit results, as well as on changes to legislative, statutory, and / or University requirements.
• Provide advice, guidance, and problem resolution to research investigators and support personnel in the application of relevant Federal, State, and local laws, regulations, and guidelines regarding human research matters including clinical trials registration and reporting and responsible conduct of research.
• Serve as an important partner in the University's desire to grow its clinical and translational research programs across all campuses while meeting the goals of efficiency and effectiveness and maintaining practices and policies that assure continued compliance with FDA, OHRP, and AAHRPP accreditation requirements.
• Assist with specific inquiries related to scientific misconduct and / or IRB-related non-compliance issues, as requested.

Minimum Qualifications :

• Master's degree.
• At least 8 years of experience directly related to the duties and responsibilities specified, with at least 3 of these years in a supervisory role.
• Certified IRB Professional (CIP) or other appropriate certification as a research professional.

Preferred Qualifications :

• Demonstrated work experience with increasing responsibility in a human subjects protection program.
• Knowledge of AAHRPP standards and accreditation requirements.
• Knowledge of HIPAA regulations and state laws governing privacy.
• Working knowledge of scientific and medical concepts, terminology, and clinical care procedures and standards.
• Working knowledge of good clinical / research practices and standards.
• Working knowledge of graduate and undergraduate research.

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