Manages the day-to-day operations of the Internal Review Board (IRB) office. Directs and manages staff; directs and manages human research protocol review operations (IRB operations), as well as interactions with external IRBs; assists in the development, implementation and communication of policies, standard operating procedures (SOPs) and guidance regarding human subject research; provides support to the IRB Director. The incumbent must be very knowledgeable in federal and state regulations related to human subjects research. S/he will ensure protocols are in compliance with applicable federal, state and local regulations in addition to institutional policies.
- Provides leadership, guidance and management on all aspects of day-to-day IRB operations – maintaining a culture of excellence, superior end-to-end service and rapid turnaround times.
- Ensures compliance with internal/external policies & requirements. Maintains current knowledge/expertise in federal, state, local & institutional policies, procedures & guidelines. Advises on best strategic approaches.
- Serves as deputy to IRB Director, including acting in this capacity (with defined responsibilities) in his/her absence, attends meetings on behalf of the director, or serves as delegate on institutional committees, as needed.
- Assists with conducting training and education outreach for the research community and/or IRB staff on relevant human research topics.
- Assists in identifying and tracking key performance metrics for reporting and staff performance management. Ensures high quality reporting in alignment with institutional needs. Integrates performance metrics into performance reviews.
- Assists with onboarding/training new IRB members and providing ongoing education to current IRB members on various human research protections.
- Serves as the direct supervisor of each IRB administration team manager, including tracking performance, conducting annual performance evaluations and providing guidance in operations or human research regulations, as necessary.
- Conducts regular staff meetings. Addresses staff conflict and individual performance issues. Assists with resourcing space and staffing needs. Provides guidance to supervisors on best practices of direct report management.
- Performs other related duties as assigned
Bachelor's Degree in a scientific or related field.
Certified IRB Professional (CIP) Certification is preferred.
At least 5 years of direct IRB administration experience of which at least 3 years includes directly managing or leading IRB staff.
Demonstrated leadership and mentoring skills to effectively manage and develop staff members.
Demonstrated ability to clearly and effectively communicate to individuals at all levels, including junior research staff, senior researchers (senior faculty members), IRB members and college senior officials.
Strong knowledge of and ability to apply federal human research regulations (OHRP, FDA and NIH) and ethical standards for research with human subjects.
Knowledge of additional non-DHHS federal regulations (Department of Defense, National Science Foundation, etc.) and New York State regulations for human subject research a plus.
Working knowledge of IRB operations best practice in accordance with standards established by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) desired.
Experience working in an academic medical center IRB office highly desired.
Working knowledge of commercial IRB database systems/software, e.g. InfoED a plus.
Knowledge, Skills and Abilities
- Demonstrated strong communication and interpersonal skills; demonstrated ability to interact with multiple constituencies and exercise "people skills".
- Demonstrated proficiency with MS Office Suite and database applications.
- Demonstrated organizational skills and ability to pay close attention to detail.
- Demonstrated critical thinking and analytical skills.
- Demonstrated ability to multi-task and prioritize in a fast-paced environment.
- Demonstrated ability to remain focused despite frequent interruptions.
- Ability to treat confidential information with utmost discretion.
- Demonstrates ability to exercise standards of professionalism, including appearance, presentation and demeanor.
- Demonstrated ability to work effectively in a collaborative manner with all departmental faculty and staff, as well as other institutional representatives.
Licenses and Certifications
Working Conditions/Physical Demands
Ability to sit at a desk and perform tasks on a computer for extended lengths of time.
Ability to travel, periodically, to meetings on the main medical campus.