Director, IRB Administration - Remote

Description

The Office of IRB Administration (OIA) is responsible for the implementation, management and oversight of human subjects research and stem cell research conducted by UC San Diego investigators. The Institutional Official with delegated authority over human subjects research by the Chancellor is a physician and Senior Associate Vice Chancellor for Health Sciences. Consequently, this office resides in Health Sciences, however the Office of IRB Administration supports all human research across Campus and all Vice Chancellor areas.

Operationally, in accordance with federal, state, and UC policy requirements, the OIA supports seven research review committees: six Institutional Review Boards (IRBs) including five biomedical, one social & behavioral, and one Stem Cell Research Oversight Committee (SCRO). The OIA also manages relationships with a range of external IRBs, and provides ongoing education and support to study teams and faculty.

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. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.

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.

Noted responsibilities include leadership and oversight of compliance programs, policy development and execution, and acting as liaison with regulators, with internal and external stakeholders, and at national conferences and meetings.

• 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.
• Represents the organization and the University of California at national conferences and meetings related to compliance area.
• Represents the organization and the University of California at national conferences and meetings related to compliance area.
• Serves as a liaison…