IRB Administration Associate Director (Hybrid)

San Diego Supercomputer Center; San Diego (CA); Hybrid; USD 91,000 - 147,000; Full time

Job summary

UC San Diego Health Sciences seeks an Associate Director of the Office of IRB Administration to oversee policies and procedures for human subject research, manage staff across IRBs and SCRO, and coordinate with federal regulators. This role ensures regulatory compliance and supports campus policy development.

The position requires extensive leadership, federal/state regulatory knowledge, and excellent communication to interact with researchers, committee members, and senior leadership.

Qualifications

• Nine (9) years of relevant experience or a Bachelor's degree plus five (5) years of relevant experience.
• Managerial experience and proven success in managing compliance review board or committee.
• Skill in managing established relationships with regulatory agencies for relevant compliance area.
• Ability to apply a complex array of issues, mental flexibility, and creativity to relevant compliance area
• 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.
• Demonstrated ability to recruit, train and supervise program staff in the interpretation and implementation of complex regulations.
• 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.
• 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.

Responsibilities

• Oversight, administration, implementation, and management of policies and procedures related to human subject research conducted by UCSD investigators.
• Supervision of staff in support of the six Institutional Review Boards (IRBs) and the one Stem Cell Research Oversight Committee (SCRO).
• Ensures program accountability for federally mandated research review committees and compliance with federal regulations, state laws, and institutional policy applicable to research involving human subjects.
• Collaborates with the Director in developing and updating campus policies, guidance, and procedures and implementing changes based on regulatory and institutional policies.
• May have contact with federal agencies such as HHS-OHRP and FDA.
• Administers policies and procedures in designated research compliance area conforming to established federal and state agency regulations.
• Receives assignments in the form of objectives with goals and the process by which to meet goals.
• Provides direction to staff according to established policies and management guidance.

Skills

Leadership

Regulatory compliance

Supervisory experience

Communication skills

Recruitment and training

Education

Bachelor's degree + 5 years relevant experience

Nine years of relevant experience

Job description

UC San Diego Health Sciences seeks an Associate Director of the Office of IRB Administration to oversee policies and procedures for human subject research, manage staff across IRBs and SCRO, and coordinate with federal regulators. This role ensures regulatory compliance and supports campus policy development.

The position requires extensive leadership, federal/state regulatory knowledge, and excellent communication to interact with researchers, committee members, and senior leadership.