IRB Administrator

Organizational Context The Olive View-UCLA Education & Research Institute (ERI) is a California 501(c)(3) nonprofit public benefit corporation that administers sponsored research and Institutional Review Board (IRB) studies at Olive View-UCLA Medical Center, a Los Angeles County Department of Health Services (DHS) hospital in Sylmar affiliated with the UCLA David Geffen School of Medicine (DGSOM). ERI holds a Federal Wide Assurance (FWA #00000495) and manages the full IRB administration function for the medical center. ERI is in an active period of organizational revitalization under new executive leadership, with a mandate to grow the research portfolio, strengthen investigator support, and raise ERI's profile as a research administration center of excellence. The IRB Administrator plays a central role in all three strategic pillars. Position Overview The IRB Administrator is responsible for the comprehensive administration of ERI's IRB program, from initial submission through study closure, and serves as the primary operational resource for investigators conducting human subjects research at Olive View-UCLA Medical Center. This position ensures regulatory compliance, supports the IRB committee, and delivers the responsive, investigator-centered service that is a hallmark of ERI's service model. The IRB Administrator reports directly to the Executive Director and works closely with the attending IRB committee membership, the medical center's Professional Staff Association, and research teams across clinical departments. Given ERI's growth trajectory, this position carries significant opportunity for professional development and expanded responsibility. Essential Duties and Responsibilities IRB Protocol Administration Manage the full life cycle of IRB submissions in

IRBNet:

initial review, continuing review, amendments, adverse event/unanticipated problem reports, and study closures. Conduct pre-review of submissions for completeness, regulatory sufficiency, and consistency with applicable federal regulations (45 CFR Part 46, 21 CFR Parts 50/56), DHHS guidance, and ERI's IRB policies. Coordinate exempt and expedited determinations per the Revised Common Rule (2018 Requirements); prepare correspondence and communicate determinations to investigators within established turnaround standards. Prepare agendas, meeting materials, and minutes for full-board convened IRB meetings; ensure quorum and adequate expertise review requirements are met. Maintain accurate and audit-ready study files in IRBNet; ensure protocol records, consent forms, correspondence, and approvals are complete and organized. Track and manage continuing review expiration dates, study milestones, and reportable events to prevent lapses in approval. Regulatory Compliance and Quality Assurance Interpret and apply federal human subjects protection regulations (45 CFR Part 46; 21 CFR Parts 50, 56, 312, 812), HIPAA Privacy Rule (45 CFR Parts 160/164), ICH E6(R2) GCP guidelines, and California state law requirements for human subjects research. Monitor regulatory updates from OHRP, FDA, and NIH; advise the Executive Director and IRB Chair on the impact of regulatory changes on ERI's program. Support internal audits and preparation for external regulatory inspections, including OHRP for-cause audits, FDA inspections, and sponsor monitoring visits. Develop and maintain IRB SOPs, policy documents, and investigator guidance materials; recommend updates as regulatory requirements evolve. Assist in maintaining ERI's FWA registration and

OHRP IRB

registration through the OHRP Human Subject Assurance Training and compliance systems. Investigator and Research Team Support Serve as ERI's primary IRB resource for investigators and research coordinators; provide responsive, knowledgeable guidance on protocol design, consent requirements, reportable events, and regulatory pathways. Conduct new investigator orientations and ongoing education on human subjects protection requirements, IRB processes, and ERI submission procedures. Review and provide feedback on informed consent documents for regulatory compliance, plain language standards, and health literacy best practices; ensure Spanish-language consent requirements are met for studies enrolling Olive View's predominantly Spanish-speaking patient population. Collaborate with sponsored research staff on grant applications and contract review where IRB oversight requirements are implicated. Participate in ERI's PI concierge service model, providing high-touch, responsive support to investigators across the medical center's clinical departments. IRB Committee Support Support the IRB Chair and committee members in conducting substantive, compliant review; prepare written analyses and summaries of complex or novel protocols for committee consideration. Coordinate IRB membership rosters, training documentation (CITI Program), and COI disclosures; maintain membership records for OHRP registration accuracy. Draft IRB approval letters, contingent approval letters, and required modifications correspondence; ensure communications are accurate, complete, and timely. Maintain the IRBNet system, including user account management, study routing, and report generation. Administrative and Strategic Contributions Contribute to ERI's strategic goal of growing and diversifying the research portfolio by facilitating efficient, investigator-friendly IRB processes that reduce barriers to study activation. Prepare IRB metrics and reporting for the Executive Director and Board, including submission volumes, turnaround times, study activity by department, and compliance indicators. Support ERI's annual Research Symposium and other investigator engagement activities. Perform other duties as assigned consistent with the scope of this position. Minimum Qualifications Bachelor's degree in a relevant field (biological sciences, health sciences, public health, social sciences, healthcare administration, or related discipline). Minimum three (3) years of progressive experience in IRB administration or human subjects research compliance at an academic medical center, hospital, research institute, or university. Demonstrated working knowledge of 45 CFR Part 46 (Common Rule/Revised Common Rule), 21 CFR Parts 50 and 56, HIPAA Privacy Rule, and ICH E6(R2) GCP guidelines. Proficiency with electronic IRB management systems; experience with IRBNet strongly preferred. Ability to work independently, manage competing priorities, and meet regulatory deadlines in a fast-paced environment. Strong written and verbal communication skills; ability to explain complex regulatory requirements clearly to diverse audiences including clinicians, researchers, and support staff. Demonstrated commitment to research ethics and human subjects protection. Preferred Qualifications Certified IRB Professional (CIP) credential, or active progress toward CIP certification. Experience at a safety-net or county hospital system, LA County DHS facility, or DHS/academic medical center affiliation. Familiarity with sponsored research administration and the interface between IRB oversight and grants/contracts management (2 CFR Part 200, NIH Grants Policy Statement, FDA-regulated research). Experience supporting investigator-initiated and industry-sponsored clinical trials, including multi-site studies and reliance agreements (single

IRB/SMART IRB

). Working knowledge of OHRP compliance oversight processes, including FWA maintenance and IRB registration. Bilingual English/Spanish — strongly preferred given Olive View's patient population and the need to review Spanish-language consent documents. Familiarity with LA County DHS research governance structure and/or

UCLA DGSOM

research administration. Experience with Microsoft 365 / SharePoint / Teams in a research or healthcare administrative environment. Work Environment This position is based on-site at Olive View-UCLA Medical Center in Sylmar, California, with limited hybrid flexibility as operational needs allow. The role requires occasional attendance at IRB committee meetings during standard business hours, and may require periodic off-hours availability for time-sensitive regulatory matters. Some travel to UCLA's Westwood campus or other DHS facilities may be required. Any hybrid work arrangement will be documented in writing. Employees approved for hybrid work are entitled to reimbursement for necessary home-office expenses under California Labor Code § 2802; ERI will provide guidance on eligible expenses at the time any such arrangement is approved. At-Will Employment Employment with ERI is at-will. This means that either ERI or the employee may terminate the employment relationship at any time, with or without cause, and with or without advance notice, subject to applicable law. Nothing in this position description, any offer letter, or any ERI policy or practice constitutes a contract of employment for a definite term or alters the at-will nature of employment. Equal Opportunity Employer The Olive View-UCLA Education & Research Institute is an equal opportunity employer committed to diversity and inclusion in all aspects of its workforce. ERI does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, marital status, veteran or military status, or any other characteristic protected by applicable law.

Pay:

$70,000.00 - $90,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off Retirement plan Vision insurance

Experience:

IRB Administrator:

2 years (Preferred) Ability to

Commute:

Sylmar, CA 91342 (Preferred)

Work Location:

Hybrid remote in Sylmar, CA 91342