IRB Manager

Albert Einstein College of Medicine•New York, NY

7d•Hybrid

About The Position

Albert Einstein College of Medicine is a leading academic medical institution dedicated to excellence in medical and graduate education, biomedical research, and clinical investigation.

Requirements

Bachelor’s degree is required; Master's degree is preffered; an equivalent combination of relevant education and experience may be considered.
Five to seven years of direct IRB or human research protections experience required.
Demonstrated ability to interpret and apply federal and state regulations, regulatory guidance, and institutional policies governing human-subject research.
Knowledge of applicable requirements, including 45 CFR 46 and 21 CFR Parts 50, 56, 312, and 812 required.
Experience reviewing complex biomedical, behavioral, and social-science research submissions required.
Strong leadership, organizational, analytical, problem-solving, written communication, and interpersonal skills.
Ability to manage competing priorities, exercise sound judgment, and handle confidential or sensitive matters appropriately.

Nice To Haves

Demonstrated progressive supervisory, team-lead, or substantial staff-mentoring experience is strongly preferred.
Certified IRB Professional (CIP) credential is preferred; candidates who do not have cerification will be required to obtain within one year

Responsibilities

Directly supervises an assigned team of IRB analysts, including assigning and monitoring work, establishing performance expectations, providing feedback and coaching, supporting professional development, and completing performance evaluations.
Oversees the operations of two to three assigned ancillary committees or regulatory functions within OHRA, ensuring that responsibilities are completed accurately, efficiently, and in accordance with applicable requirements and institutional policies.
In collaboration with the Assistant Director of Operations, manages the day-to-day administrative, operational, and compliance activities associated with IRB submissions and review processes.
Monitors staff workloads, submission volume, turnaround times, and workflow performance; identifies operational concerns and recommends or implements process improvements.
Trains and mentors new and existing IRB analysts and develops or coordinates educational materials and resources to promote consistent regulatory interpretation and review practices.
Serves as a subject-matter resource for IRB analysts, investigators, research staff, IRB members, and other institutional stakeholders regarding human subjects research requirements and submission processes.
Works closely with IRB Chairs, the Assistant Director of Operations, and the OHRA Executive Director to evaluate reportable events, facilitate initial triage, and support determinations and institutional reporting, as applicable.
Reviews complex IRB submissions and related materials to identify regulatory, ethical, and institutional concerns and provides guidance to analysts and research teams regarding required revisions.
Makes or facilitates institutional engagement and IRB reliance determinations in accordance with applicable regulations, guidance, institutional policies, and delegated authority.
Serves as an IRB member and performs reviews within the scope of the authority delegated to the position.
Independently manages assigned IRB meetings, including coordinating agendas, assigning submissions to staff and IRB members, confirming quorum and appropriate expertise, providing regulatory and procedural guidance during meetings, and reviewing meeting minutes and correspondence for accuracy.
Collaborates with OHRA leadership and IRB Chairs to develop, review, and update policies, procedures, guidance documents, forms, templates, and educational materials.
Conducts or supports quality assurance and quality improvement activities, including assessing files and workflows, monitoring performance metrics, identifying trends, and recommending corrective or preventive actions.
Develops and provides education, training, and regulatory consultations for faculty, staff, students, IRB members, and other members of the research community.
Represents OHRA on assigned institutional committees, workgroups, and initiatives related to humans subject research.
Processes IRB submissions, drafts meeting minutes, and performs other IRB operational responsibilities as needed to support departmental workload and continuity of operations.
Maintains current knowledge of applicable federal and state regulations, regulatory guidance, accreditation standards, institutional policies, and evolving practices in human-subject research oversight.
Performs other related duties as assigned.