Assistant Director, Research Compliance

University of the Pacific•Stockton, CA

About The Position

Primary Purpose Serves as the Institutional Research Board (IRB) Manager for all three campuses. Responsible for interpreting IRB federal, state, local, and other regulations as they apply to IRB human research protocols and/or proposals and then directing, reporting, and monitoring adherence for all three University campuses grants, contracts and any activities involving human research (Institutional Review Board [IRB]) under Federal Wide Assurances. Fully manage IRB protocols and process and administer incoming sponsored contracts. Serves as the Institutional Review Board (IRB) Manager for all three campuses. Oversees the review, approval, and monitoring of IRB regulations and protocols, as well as the administration of sponsored research contracts and activities under Federal Wide Assurance. University of the Pacific recognizes that diversity, equity, and inclusion is foundational to the success of our valued students and employees. We prioritize policy and decision-making that demonstrates awareness of, and responsiveness to, the ways socio-cultural forces related to race, gender, ability, sexuality, socio-economic status, etc. impede or propel students, faculty and staff.

Requirements

Bachelor’s Degree.
Two (2) years of experience working with IRB.
Experience working with data.

Nice To Haves

Certified IRB Professional.
Experience working with faculty and students.
Intermediate to advanced skills in MS Office suite, and Adobe Acrobat Pro.
Ability to adapt to emerging technology.
Excellent wiring and oral communication skills.
Excellent event/meeting scheduling and records management skills.
Positive attitude, proven ability to work successfully with diverse populations and demonstrated commitment to promote and enhance diversity and inclusion.
Experience in a laboratory setting.
Experience and sensitivity in working with people of diverse backgrounds and cultures.
Demonstrated experience in advancing social justice, equity, and inclusion in a university setting.
Ability to engage and integrate culturally responsive practices and knowledge in their work.

Responsibilities

Direct and oversee IRB operations across all campuses, ensuring compliance with federal, state, and institutional regulations; manage protocol review, approval, monitoring, and reporting processes.
Serve as primary reviewer with authority to make not-human-subjects research and/or exemption determinations; expedited determinations; approve minor changes in research not otherwise eligible for expedited review.
Serve as a voting member and administrator of the IRB Committee, report new information, and prepare submissions for monthly convened IRB meetings.
Manage IRB submissions and correspondence; anticipate and resolve problems; communicate project status to leadership.
Provide guidance, training, and regulatory interpretation to faculty, staff, and IRB members; ensure compliance with human subjects protections.
Conduct internal and external audits of IRB and IRB protocol Principal Investigators for cause and not-for-cause; prepare annual reports and update policies in alignment with evolving regulations.
Manage the administrative pre-award incoming sponsored contracts process, including budget review, review requirements and compliance verifications, and maintain accurate records within the Cayuse software system.
Review, administer, and process incoming sponsored programs, including contracts and grants, for compliance.
Support Sponsored Programs as needed.
Prepare and submit required reports and regulatory notifications to federal agencies (e.g., OHRP, NIH) and ensure timely compliance with applicable reporting requirements.
Maintain databases for protocols, compliance documentation, training records, and related research administration activities; ensure adherence to all applicable regulations and standards.
Serve as a primary liaison to campus stakeholders; provide guidance, resolve complex issues, and promote best practices in research compliance.
Perform other duties as assigned.