Director, Research Subject Protection (0377U), Research Admin & Compliance - #82793

At the University of California, Berkeley, we are dedicated to fostering a community where everyone feels welcome and can thrive. Our culture of openness, freedom and belonging make it a special place for students, faculty and staff.

As a world-leading institution, Berkeley is known for its academic and research excellence, public mission, diverse student body, and commitment to equity and social justice. Since our founding in 1868, we have driven innovation, creating global intellectual, economic and social value.

We are looking for applicants who reflect California's diversity and want to be part of an inclusive, equity-focused community that views education as a matter of social justice. Please consider whether your values align with our Guiding Values and Principles, Principles of Community, and Strategic Plan.

At UC Berkeley, we believe that learning is a fundamental part of working, and provide space for supportive colleague communities via numerous employee resource groups (staff organizations). Our goal is for everyone on the Berkeley campus to feel supported and equipped to realize their full potential. We actively support this by providing all of our full-time staff employees with at least 80 hours (10 days) of paid time per year to engage in professional development activities. Find out more about how you can grow your career at UC Berkeley.

Departmental Overview

The Office of Research Administration & Compliance (RAC) works with faculty, staff, and students across UC Berkeley to catalyze, support, and safeguard research and innovation. Ensuring research compliance, safety, and security across the university is a key priority because the overall success of the research enterprise depends on the highest standards of ethics, compliance, and integrity.

Research Subject Protection is divided into three committees:

The Committee for Protection of Human Subjects (CPHS) serves as the institutional review board (IRB) at UC Berkeley. The IRB must review and approve the use of human subjects in research. The process is designed to ensure that the rights and welfare of human subjects are protected throughout their participation in research projects. The Office for Protection of Human Subjects (OPHS) provides operational and staffing support to the CPHS and administers all human subjects research performed on behalf of UC Berkeley.

The Animal Care and Use Committee (ACUC) at UC Berkeley is the institutional committee charged with reviewing and approving all proposed uses of live vertebrate animals in teaching and research. The Office for Animal Care and Use (OACU) provides the administrative infrastructure required to support the Committee's work to review, approve, and administer those activities.

The purpose of the UC Berkeley SCRO Committee and associated Stem Cell Research Oversight Office (SCRO) is to ensure that human stem cell research undertaken at the University is performed according to the highest ethical and scientific standards.

Position Summary

Reporting to the Assistant Vice Chancellor for Research Administration & Compliance, the Director of Research Subject Protection directs the operational management and regulatory oversight of the institution's research compliance program as the campus authority. This pivotal role oversees the Committees for Protection of Human Subjects (CPHS), the Animal Care and Use Committee (ACUC), and the Stem Cell Research Oversight Committee (SCRO).

The Director ensures institutional adherence to all complex federal, state, and institutional regulations, including the Common Rule, the Animal Welfare Act (AWA), PHS Policy, and human stem cell research guidelines. To achieve this, the Director leads the Office for Protection of Human Subjects (OPHS), the Office for Animal Care and Use (OACU), and the Stem Cell Research Oversight (SCRO) Office.

Through these offices, the Director provides independent, high-level analytical support to committee leadership, the AVC for Research Administration and Compliance, the Institutional Official, and campus investigators. The Director drives administrative processes for protocol review, committee management and documentation, manages committee membership, and develops and implements compliance monitoring programs. Finally, this role develops and delivers expert guidance, training, and educational programs to the research community, cultivating a culture of ethical, humane, and compliant research involving human subjects, animals, and stem cells.

Application Review Date

The First Review Date for this job is: 12/15/2025.

Responsibilities

Serve as the Institutional Official's (IO) and AVC for Research Administration & Compliance's designee to oversee and manage the research subject protection units (OPHS, OACU, and SCRO) and research subject protection committees.

• Lead and supervise the administrative staff within these offices and provide management for the associated regulatory committees: the IRB, IACUC, and SCRO.
• Lead staff recruitment and hiring activities for OPHS, OACU and SCRO. Lead the development, implementation, and maintenance of appropriate policies, procedures, processes, and records.
• Represent UC Berkeley at external meetings and conferences, including UC systemwide meetings.

Oversee the protocol review process for all research involving human subjects, animals, and human stem cells.

• Ensure all review processes comply with institutional policies, state and federal regulations, and relevant best practices.
• Manage eProtocol, Berkeley's online application system for IRB and IACUC protocols.
• Serve as a core regulatory expert, a voting member on CPHS, ACUC, and SCRO, and a regulatory expert or ex-officio advisor to the other Berkeley regulatory committees.

Develop, implement, and manage efficient administrative procedures that align institutional policies with federal regulations and guidelines for the IRB, IACUC, and SCRO.

• Maintain regulatory assurances and registrations with federal agencies, including updating agreements and committee member rosters, and filing mandated internal and external reports.
• Ensure all committee administrative and protocol files are maintained and retained according to strict federal requirements.
• Under delegated authority from the IO, review and sign collaborative research oversight agreements with external entities.

In collaboration with Committee Chair(s) and/or the Attending Veterinarian, receive, review, and process all non-compliance reports, incident reports, and subject complaints related to the research protocols and committee operations.

• May involve executive committee review.
• Oversee the development and implementation of a robust Post-Approval Monitoring (PAM) program to ensure approved procedures are followed and health/welfare standards are maintained.
• Lead for-cause investigations when deemed necessary, such as in response to a third-party noncompliance report or subject complaint.
• Oversee semi-annual programmatic reviews and provide the reviews to Berkeley's IO.
• Coordinate Berkeley's AAALAC program description and site visit.
• May act as a liaison and escort for federal and state inspectors during campus audits, inspections, and site visits.

Develop and present comprehensive educational and training sessions on the ethical and compliant conduct of research and the IRB/IACUC/SCRO processes.

• Oversee these activities when conducted by staff.
• Provide expert guidance to faculty, staff and students regarding federal and institutional requirements for complex research protocols involving human subjects, animals, and stem cells.
• Serve as the primary liaison between the research protection committees and external regulators, funding agencies, collaborating institutions, and critical internal campus partners (e.g., Office of General Counsel, EH&S, Privacy Officer).
• Liaison with the Public Records Office to respond to public records requests.
• Liaison with the Locally Designated Official (LDO) to investigate whistleblower reports when related to human, animals, or stem cell compliance.

Manage the content and maintenance for the Research Subject Protection sections of the Research Administration and Compliance website, newsletters, and other forms of education and awareness, ensuring information is accurate and accessible.

Required Qualifications

• Expert-level technical proficiency in a broad range of research compliance regulations and best practices.
• Deep regulatory knowledge and experience in applying risk management principles to a complex research environment.
• Proven ability to formulate, develop, and recommend a broad range of research-related compliance policies for a large institutional setting.
• Strategic and innovative thinking to enhance the effective and efficient development and implementation of campus-wide compliance programs, ensuring alignment with new or changing research regulations.
• Exceptional stakeholder management skills, with a track record of successfully managing relationships with senior campus leadership, researchers, funders/investors, and government agencies (local, state and federal).
• Demonstrated pragmatic judgment and business acumen to effectively balance regulatory compliance requirements against operational needs and resources limitations.
• Advanced program development, interpersonal, and written/verbal communication skills, with the ability to influence and persuade a variety of audiences.
• Ability to lead and mentor others.
• Advanced degree in related area and/or equivalent experience/training.

Preferred Qualifications

• Certified Compliance, IRB, IACUC, or Related Professional.

Salary & Benefits

For information on the comprehensive benefits package offered by the University, please visit the University of California's Compensation & Benefits website.

Under California law, the University of California, Berkeley is required to provide a reasonable estimate of the compensation range for this role and should not offer a salary outside of the range posted in this job announcement. This range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, analysis of internal equity, and other business and organizational needs. It is not typical for an individual to be offered a salary at or near the top of the range for a position. Salary offers are determined based on final candidate qualifications and experience.

The budgeted annual salary range that the University reasonably expects to pay for this position is $194,650.00 - $233,400.00.

• This is a full-time (40 hours/week), career position that is eligible for UC Benefits.
• This is an exempt monthly-paid position.

How to Apply

• To apply, please submit your resume and cover letter.

Other Information

• This is not a visa opportunity. This position does not include sponsorship of a new consular H-1B visa petition that would require payment of the $100,000 supplemental fee.

Conviction History Background

This is a designated position requiring fingerprinting and a background check due to the nature of the job responsibilities. Berkeley does hire people with conviction histories and reviews information received in the context of the job responsibilities. The University reserves the right to make employment contingent upon successful completion of the background check.

Misconduct

SB 791 and AB 810 Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

"Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment, discrimination, dishonesty, or unethical conduct, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct:

UC Sexual Violence and Sexual Harassment Policy

UC Anti-Discrimination Policy

Abusive Conduct in the Workplace

Equal Employment Opportunity

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.