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Inside Higher Ed · 1 week ago

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

Berkeley, CA

Full-time

Onsite

Director/Executive

$195K/yr - $233K/yr

The University of California, Berkeley is a world-leading institution known for its academic and research excellence. The Director of Research Subject Protection oversees the operational management and regulatory oversight of the institution's research compliance program, ensuring adherence to federal, state, and institutional regulations regarding human subjects, animals, and stem cell research.

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No H1B

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

Qualification

Research compliance regulationsRisk management principlesPolicy developmentStakeholder managementProgram developmentAdvanced degreeCompliance certificationInterpersonal skillsWritten communicationVerbal communicationLeadership

Required

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