Having wide-ranging experience, uses research compliance concepts and organization objectives to resolve the most complex issues having organization-wide impact. Works on challenging issues where little or no organization precedent exists, and analysis of situation(s) or data require an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, including lean six sigma and evaluation criteria for obtaining results. Internal and external contacts often pertain to organization plans and objectives. Is considered a subject matter expert in the organization and often recognized as an expert externally in the industry. Under the general direction of the Director, Human Research Protections, this position is responsible for operational direction and strategic management of the human Stem Cell Research Oversight Committee (hSCRO), collaborative Institutional Review Board (IRB) Reliance program (Reliance) and Education and Quality Improvement Program (EQUIP), including reimplementation of a monitoring program that includes reliance, and the supervision of teams supporting each program. Responsible for keeping abreast of national, state, and University of California regulatory developments to ensure that compliance committees operate in accordance with all relevant compliance regulations. Recommends and implements policies and procedures based on federal and state agency regulations for relevant compliance areas. Provides leadership over the hSCRO compliance committee and manages all issues related to including any annual reporting requirements. Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules as it relates to the facilitation of human subject or hSCRO research. In addition, having wide-ranging experience, the incumbent is responsible for the ongoing education of Human Research Protections (HRP) and research community. Responsible for managing HRP website content, IRB and hSCRO rosters, and program accreditation. Uses IRB delegation of authority to review and approve specific types of human subject research protocols.
NOTE: This is primarily a remote position. Infrequently, this position may need, or be required, to work on campus.
• 10 years of progressive experience in human research protections, including experience working with a hSCRO program
• 5 years of people management experience, including experience in leading a high performing team
Bachelor's degree in related area and / or equivalent experience / training.
Certified IRB Professional credential
Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments. Expert knowledge and ability to apply all of the Federal, state, system and university regulations, policies and federal guidance documents. Ability to resolve conflicts in a timely basis. Ability to interact with faculty, verbally and in writing, with professionalism and decorum. Ability to lead and mentor others.
The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. 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 categories covered by the UC nondiscrimination policy.
We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.
UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500 or eec@uci.edu.