[Remote] Director, IRB Administration (remote)

Note: The job is a remote job and is open to candidates in USA. UC San Diego Health is seeking a Director for the Office of IRB Administration, which is responsible for overseeing human subjects and stem cell research. The role involves managing compliance programs, establishing objectives, and serving as a liaison with federal regulators while supporting research review committees across the campus.

Responsibilities

• Establishes objectives and work plans, and delegates assignments to subordinate managers
• Responsible for managing, preparing, administering, and directing resources
• Reviews and approves recommendations for research compliance programs
• Involved in developing, modifying and executing policies that affect immediate operation(s) and may also have organization-wide effect
• Has broad departmental oversight and accountability for policies and procedures related to relevant compliance area
• Serves as the organization authority on relevant compliance issues, and as a liaison between the organization and federal regulators, in addition to representing the organization and the University of California at national conferences and meetings

Skills

• Bachelor's degree in a related area
• Eight (8) or more years of relevant IRB experience
• Ability to formulate broad policy recommendations for the organization
• Ability to apply a complex array of issues, mental flexibility, and creativity related to compliance issues
• Skill in establishing relationships with human subjects and regulatory agencies on local, regional, and national levels
• Managerial experience and proven success in managing compliance review boards or committees
• Comprehensive knowledge of federal, state, and local regulations and policies governing human subject research including: the HHS-OHRP regulations, FDA regulations for the use of investigational drugs, biologics and devices, California law on human experimentation, and university policy regarding human subjects research
• Demonstrated ability to recruit, train and supervise program staff in the interpretation and implementation of complex regulations. Excellent supervisory skills and sound judgment necessary to organize workload, delegate responsibilities, evaluate and perform corrective action/discipline staff
• Ability to independently and accurately represent UCSD policies regarding human subjects research in interactions with high level administrators of other universities, academic and community health centers, research sponsors, and federal and state regulatory agencies
• Working knowledge of a significant body of scientific and medical concepts and terminology to properly review research protocols, request necessary additional information from researchers prior to review of unanticipated problems, adverse events or possible violations of human subject protection policy, to evaluate actions taken by investigators in response to committee requests, and to ensure compliance with the approved protocols
• Highly effective written, oral communication skills, interpersonal skills and sound judgment necessary to work closely and effectively with faculty members conducting research, committee members, committee chairpersons, senior academic and administrative officers, and federal regulators
• Demonstrated ability to understand and to formulate both graphical and narrative reports outlining the activity of the IRB
• Experience with exercising strong leadership and supervisory skills in personnel management including experience in providing direction, knowledge of sound management practices, team building techniques, providing recommendations in hiring and performance appraisals; providing guidance and instructions and communicating in an effective, professional and direct manner, and provide disciplinary action as needed
• Knowledge and ability to represent the organization and the University of California at national conferences and meetings related to compliance area
• Knowledge and ability to serve as a liaison between organization and federal regulators (for example, DOE, FDA, et cetera)
• Current or previous Council for Certification of IRB Professionals (CIP) certification
• Thorough knowledge of UCSD and UC governance, organizational structures, and communication channels; and of UCSD research programs and activities

Company Overview

• UC San Diego Health is the only academic health system in the San Diego region. It was founded in 1966, and is headquartered in San Diego, California, USA, with a workforce of 10001+ employees. Its website is https://health.ucsd.edu/.

Company H1B Sponsorship

• UC San Diego Health has a track record of offering H1B sponsorships, with 308 in 2025, 261 in 2024, 232 in 2023, 223 in 2022, 131 in 2021, 105 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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