The Director oversees the day-to-day operations of the institutional Review Board (IRB), including Full Board IRB Committee Review, Expedited and Exempt Review, Protocol Adherence Review Committee, and working with the iStar Development Team to ensure that the electronic IRB system meets the needs of IRB staff and members of the USC research community. The Director reports to the Director for the Office for the Protection of Research Subjects.
PRIMARY DUTIES AND RESPONSIBILITIES:
Working closely with the IRB Chairs to ensure that the operational and support functions for the IRB committees are provided and maintained.
Responsible for setting the tone of collaboration between the IRB and all USC constituents (students, faculty, staff).
Oversees the IRB review process ensuring the research conducted by USC faculty, staff, and students is compliant with federal and state regulations governing research.
Conducts reviews of expedited and exempt applications as necessary.
Developing and managing the budget within department budget guidelines.
Overseeing administration and research compliance applicable to the Office for Human Research Protection Program (OHRP), Food and Drug Administration (FDA) regulations, federal funding agency requirements, state law and University policies during IRB and administrative reviews.
Providing oversight for the ongoing work of the IRBs on human subject research including administrative operations, and in conjunction with OPRS, providing orientation and continuing education to IRB members and implementation of policies and procedures.
Ensure appropriate documentation of IRB actions, and maintain records and correspondence related to IRB activity in accordance with applicable law and accreditation standards.
Advising the University research community on federal regulations and institutional policies and procedures to ensure institutional compliance with the ethical and regulatory requirements for human subject research. Working collaboratively with investigators to find creative ways to advance research goals while meeting compliance needs and challenges.
Organizing regular meetings of IRB staff and leadership; develops meeting agenda and materials, takes and distributes minutes.
Collaborating with OPRS as appropriate to gather input on policies, drafts revisions, brings revisions to the leadership group for approval, and, as appropriate, makes updates to the posted OPRS policy and procedure manuals.
Supporting AAHRPP accreditation process and maintain AAHRPP accreditation status and reporting requirements. Supports the AAHRPP re-accreditation application and site visit processes.
Consulting with federal agency staff, as necessary, regarding the interpretation and implementation of guidelines. Interpreting and applying federal, state and local regulations, policies and procedures related to human subject research.
Managing third party IRB reliance agreements and oversight of University research when deferred to central IRBs; overseeing studies deferred to the IRB.
Collaborating with the University's research administration, quality and compliance offices on clinical research matters, as appropriate.
Collaborate with iStar team on necessary updates to the iStar system to support the efficient submission and review of research applications.
Collaborating with the Clinical Trials Office in managing human subjects research.
Understanding the impact of any proposed regulatory changes on institutional policies pertaining to human subject research and implementing policy and procedure changes as appropriate.
Master's degree or higher and at least 5 years of experience directly related to the duties, doctorate preferred.
At least three years of management experience; demonstrated experience with increasing responsibility in a human subject protection program. Biomedical and behavioral research experience is ideal.
Knowledge of AAHRPP standards and accreditation requirements; knowledge of HIPAA regulations and state laws governing privacy.
Working knowledge of scientific and medical concepts, terminology, and clinical care procedures and standards; working knowledge of good clinical/research practices and standards.
Prior experience developing and implementing training and education (adult education) initiatives in a research setting.
Practiced negotiator and creative problem solver; adept at conflict resolution.
Prior experience working with commercial IRB committees.
Open and transparent approach to working with University stakeholders/departments requesting IRB information for compliance or business purposes.
Ability to manage competing priorities in a fast-paced environment.
Outstanding written and verbal communication skills.
CIP (Certified IRB Professional) or CIM (Certified IRB Manager) certification.
High degree of familiarity with FDA Investigational New Drug (IND), Investigational Device Exemption (IDE) and Humanitarian Use Device (HUD) requirements.
Prior experience utilizing the Single IRB model.
In depth understanding of laws, rules, and regulations governing human subject research including HIPAA regulations and Good Clinical Practice.
Working knowledge and understanding of biosafety policies and procedures preferred.
Exposure to international research projects is highly desirable.
Excellent organizational and project management skills.
Ability to work collaboratively with a diverse set of stakeholders and build effective interdisciplinary teams.
Excellent interpersonal and communication skills with the ability to develop and maintain effective working relationships with various constituencies, including leadership, faculty, students, administrators, members of the IRBs, clinical staff, and OPRS staff.
Excellent critical thinking, writing and editing abilities; adept at making data driven decisions.
Ability to develop and implement new policies and procedures, training and outreach.
Knowledge of enterprise research systems, databases and report generation.
Demonstrated ability to take initiative, identify, prioritize and plan activities necessary to meet goals.
Minimum Education: Master's Degree OR Combined experience/education as substitute for minimum education Minimum Experience: 7 Years Minimum Field of Expertise: Directly related program management experience. Expert knowledge of field, teaching experience and/or active in research.
USC is an equal opportunity, affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC will consider for employment all qualified applicants with criminal histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring ordinance. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at (213) 821-8100, or by email at email@example.com. Inquiries will be treated as confidential to the extent permitted by law.