Human Research Protection Program Director

Job Description

The Director of the Human Research Protection Program (HRPP) is designated by the Institutional Official (I0) to oversee and manage the campus-wide compliance program for the protection of human participants in research. The Director works closely with the Institutional Review Board (IRB), the Faculty Invested in Research Mentorship committee (FIRM), and the research community to establish and maintain a culture of compliance with regulations and policy that pertains to the protection of human participants. The Director manages, and coordinates planning, implementation, communication, education, compliance, daily administration, and record-keeping of all human research protections and responsible conduct of research activities.

Requirements/Minimum Qualifications

Experience

• Minimum of three years of professional-level experience in human research protections in a university setting.
• Experience with human research protections in Social, Behavioral, and Education Research (SBER) is mandatory.
• Proficiency in understanding, interpreting, communicating, and applying federal regulations and guidance (e.g., OHRP, HIPAA, FERPA) in human research protections.
• Proficiency in understanding, interpreting, communicating, and applying local governmental regulations, guidance, laws and/or policies in human research protections.
• Excellent interpersonal skills (e.g., networking, capacity building).
• Excellent communication (oral and written) skills.
• Excellent attention to detail and time-management skills.
• Familiarity with IRB documentation/work-flow systems.
• Experience with IRBManager is preferred, but not required.
• Familiarity with site administration of Collaborative Institutional Training Initiative (CITI) preferred, but not required.
• Proficiency with document preparation in both Microsoft 365 (e.g., word, excel, power point) and Google Workplace (e.g., docs, sheets, meet, drive).
• Familiarity with professional resources/networks in human research protections (e.g., PRIM&R).
• Self-motivated and able to work independently with minimal supervision.

Education

• Minimum of a master's degree with human research requirement (e.g., Physical Therapy, Psychology, Sociology) or a concentration in applied ethics (e.g., Bioethics, Research ethics). A Ph.D. is preferred.

Licenses/Certifications/Credentials

• The Certified IRB Professional (CIP®) credential is preferred.

Supervisory Responsibilities

May supervise Graduate Assistant/s to include training, coaching, delegating, and evaluating performance.

Essential Functions

• Maintain the Federal Wide Assurance (FWA), IRB registration, and make necessary updates.
• Coordinate all Institutional Review Board (IRB) activities.
• Administrative preview of all applications for review and approval.
• Manage, review, and approve all exempt-eligible human subject research and "Not Human Subject Research" determinations.
• Administer development, use, maintenance, and support of IRBManager platform.
• Manage coordination and authorization of all cooperative review arrangements (e.g., Institutional Reliance/Authorization Agreements, Individual Investigator Agreements).
• Coordinate and administer orientation, training, and continuing education for IRB members.
• Coordinate development, implementation, evaluation and revision of policies and procedures.
• Help coordinate human research protection education for Ulndy faculty and students.
• Administer development, use, maintenance and support of CITI subscription for faculty and student accounts.
• Respond to HRPP/IRB related questions, requests and concerns in a timely and effective manner.
• Coordinate reporting of all human research protection activities to stakeholders.
• Maintain professional credentials and relationships.
• Follow the guidance and direction of the supervisor.
• Perform employee responsibilities as detailed in the Staff Handbook.
• Other duties as required or assigned.