IRB Manager

Einstein; New York (NY); Hybrid; USD 105,000 - 115,000; Full time

Benefits offered by this job

Hybrid work arrangements

Job summary

Albert Einstein College of Medicine is seeking an experienced IRB Operations Manager to supervise a team of analysts and oversee multiple committees within OHRA. The role focuses on IRB submissions, review processes, and regulatory compliance, guiding staff and providing expert support to investigators and researchers.

The incumbent will ensure efficient workflows, mentor staff, and maintain up-to-date knowledge of federal/state regulations and institutional policies related to human-subjects

Qualifications

• Bachelor’s degree required; Master’s preferred; equivalent combination may be considered.
• Five to seven years of direct IRB or human research protections experience.
• Progressive supervisory or team-lead experience strongly preferred.
• Ability to interpret and apply federal/state regulations and institutional policies.

Responsibilities

• Directly supervise an assigned team of IRB analysts, assign and monitor work, and conduct evaluations.
• Oversee operations of ancillary committees or regulatory functions within OHRA.
• Manage day-to-day administrative, operational, and compliance activities for IRB submissions and review.
• Monitor workloads, submission volume, turnaround times, and workflows; implement improvements.
• Train and mentor staff; develop educational materials for consistent regulatory interpretation.
• Serve as a subject-matter resource for IRB analysts, investigators, and researchers.
• Collaborate with leadership to evaluate reportable events and support determinations.
• Review complex IRB submissions and provide guidance on required revisions.

Skills

Leadership

Supervisory experience

Regulatory interpretation

Analytical skills

Project management

Written communication

Interpersonal skills

Education

Bachelor's degree

Master's degree

Equivalent education/experience

Job description

About Us

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

POSITION 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.

Flexible Work Arrangements

Albert Einstein College of Medicine offers flexible work schedules and hybrid remote-work arrangements for professional and administrative staff, subject to supervisory approval. This position is eligible for consideration, and applicants are encouraged to inquire about available arrangements.

QUALIFICATIONS

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

Additional Information

In compliance with NYC's Pay Transparency Act, the annual base salary range for this position is listed below. Albert Einstein College of Medicine considers factors such as (but not limited to) scope and responsibilities of the position, candidate's work experience, education/training, key skills, internal peer equity, as well as, market and organizational considerations when extending an offer.

Minimum Salary Range: USD $105,000.00/Yr.

Maximum Salary Range: USD $115,000.00/Yr.