The Associate Director of IRB 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 Associate Director reports to the Director for the Office for the Protection of Research Subjects.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Manage and support Lead IRB Analysts in their work with their IRB teams.
- Provide input on policies, review revisions offered by OPRS that will be added to policies and procedures.
- Understand the impact of any proposed regulatory changes on institutional policies pertaining to human subject research and implement policy and procedure changes as appropriate.
- Interpret and apply federal, state, and local regulations, policies and procedures related to human subject research.
- Consult with federal agency staff, as necessary, regarding the interpretation and implementation of guidelines.
- Oversee the IRB review process ensuring the research conducted by USC faculty, staff, and students is compliant with federal and state regulations governing research.
- Provide 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.
- Work closely with the IRB Chairs, and as appropriate, Vice Chairs, to ensure that the operational and support functions for the IRB committees are provided and maintained.
- Ensure appropriate documentation of IRB actions, and maintain records and correspondence related to IRB activity in accordance with applicable law and accreditation standards.
- Collaborate with iStar team on necessary updates to the iStar system to support the efficient submission and review of research applications.
- Advise 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.
- Work collaboratively with investigators to find creative ways to advance research goals while meeting compliance needs and challenges.
- Collaborate with the University's research administration, quality and compliance offices on clinical research matters, as appropriate.
- Manage third party IRB reliance agreements and oversight of University research when deferred to central IRBs; overseeing studies deferred to the IRB.
- Maintain AAHRPP accreditation status and reporting requirements.
- Conduct reviews of full board, expedited, and exempt applications, as necessary.
- Bachelors degree or higher and at least 6 years of experience directly related to the duties, masters or doctorate preferred.
- At least 3 years of management experience; demonstrated experience with increasing responsibility in a human subject protection program. Biomedical and social 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.
- Ability to work collaboratively with a diverse set of stakeholders and build effective interdisciplinary teams.
- Practiced negotiator and creative problem solver, adept at conflict resolution.
- 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 developing and implementing training and education (adult education) initiatives in a research setting.
- Prior experience working with commercial IRB committees.
- 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.
- 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.
- Prior experience utilizing the Single IRB model.
Minimum Education: Bachelor's degree; Combined experience/education as substitute for minimum education Minimum Experience: 7 years Minimum Field of Expertise: Six years of IRB experience. Two years' experience in a lead role supervising and providing expertise on IRB submissions. Significant knowledge of complex federal, state, and local regulations, laws, policies, and ethical practices governing the research of human subjects. Ability to analyze, interpret, and evaluate, and report on information. Excellent oral and written communications skills. Proven project management skills. Excellent organization, planning, and interpersonal skills. Ability to maintain confidentiality and handle sensitive material with discretion.