IRB Compliance Specialist

employee-einstein; New York (NY); On-site; USD 72,000 - 80,000; Full time

Job summary

Albert Einstein College of Medicine in New York seeks a regulatory affairs professional to independently analyze IRB submissions, assess readiness for review, and ensure compliance with federal regulations and institutional policies.

You will draft regulatory correspondence, prepare meeting materials, train staff on IRB processes, and help improve workflows while maintaining meticulous records. This role offers growth in a collaborative research environment in NYC.

Qualifications

• Bachelor's Degree is required.
• 1-2 years of experience in an academic health center or medical school IRB is strongly preferred.
• Certification as an IRB professional (CIP) is preferred.

Responsibilities

• Independently analyzes and conducts regulatory reviews of IRB submissions, including new protocols, amendments, continuing reviews, reportable events, and other human subjects research activities to ensure compliance with applicable federal regulations, institutional policies, and ethical standards.
• Exercises independent professional judgment in evaluating submissions, identifying regulatory concerns, and determining readiness for IRB review.
• Reviews and audits IRB transactions for accuracy, completeness, and regulatory compliance; identifies deficiencies and collaborates with investigators and research staff to resolve complex issues.
• Drafts and prepares regulatory correspondence, including approval notices, determinations, requests for modifications, and other communications reflecting IRB decisions and requirements.
• Develops and coordinates meeting materials and agenda items for full board review, ensuring timely and accurate presentation of protocol information.
• Serves as a subject matter resource to investigators, study teams, faculty, students, and staff regarding IRB requirements, human subjects protections, informed consent standards, and electronic submission processes.
• Facilitates IRB meetings by supporting the review process, documenting discussions, and ensuring adherence to regulatory and institutional requirements.
• Independently prepares and maintains detailed IRB meeting minutes and regulatory records in accordance with federal and accrediting standards.
• Evaluates existing IRB forms, consent templates, workflows, and review procedures; recommends and implements process improvements to enhance operational efficiency, regulatory compliance, and customer service.
• Collaborates closely with IRB leadership, IRB members, investigators, and research administrators to address regulatory issues and support the ethical conduct of research.
• Coordinates review activities with institutional stakeholders and oversight committees, including Research Compliance, Institutional Biosafety Committee (IBC), Legal Affairs, Clinical Trials Administration, and other departments, as necessary.
• Identifies, analyzes, and escalates potential compliance concerns, protocol deviations, and process deficiencies to IRB leadership; assists with corrective action and risk mitigation efforts.
• Provides consultation and training to the research community regarding IRB policies, submission requirements, regulatory expectations, and electronic research administration systems.
• Participates in quality assurance, audit readiness, accreditation activities, and continuous process improvement initiatives.
• Maintains current knowledge of evolving federal regulations, guidance, best practices, and emerging issues related to human subjects research protections.
• Performs other related professional duties and special projects as assigned.

Education

Bachelor's Degree

IRB CIP certification (preferred)

Job description

Albert Einstein College of Medicine in New York seeks a regulatory affairs professional to independently analyze IRB submissions, assess readiness for review, and ensure compliance with federal regulations and institutional policies.

You will draft regulatory correspondence, prepare meeting materials, train staff on IRB processes, and help improve workflows while maintaining meticulous records. This role offers growth in a collaborative research environment in NYC.