Director, IRB Administration - Remote - 138423

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

• 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 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.

• Employment is subject to a criminal background check.

• Must be available to work occasional evenings and weekends.

• This position may need to be on campus up to twice at their own expense or conform to university policy in place at that time.

If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.

If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community.

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.

For the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.

Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts an 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; or have filed an appeal of a finding of substantiated misconduct with a previous employer.

a. "Misconduct" means any violation of the policies governing employee conduct at the applicant's previous place of employment, including, but not limited to, violations of policies prohibiting sexual harassment, sexual assault, or other forms of harassment, or discrimination, 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