IRB Compliance Coordinator: Research Ethics & Oversight

Sinai Chicago; Chicago (IL); On-site; USD 70,000 - 100,000; Full time

Job summary

Sinai Chicago is seeking an experienced IRB Coordinator to manage regulatory administration for MS H-IRB, ensuring compliance with federal rules and institutional policies. The role includes overseeing protocol submissions, approvals, and correspondence using the Cayuse platform, and acting as a liaison among researchers, IRB members, and sponsors.

The ideal candidate has a Bachelor’s degree in a health-related field, 1+ year of IRB or clinical research experience, and strong knowledge of 45 CFR

Qualifications

• Bachelor’s degree in health science, public health, or related field required.
• Minimum 1 year of IRB administration or clinical research coordination experience required.
• Experience with FDA-regulated trials (IND/IDE) preferred.
• Strong knowledge of 45 CFR 46, 21 CFR Parts 50, 56, 312, 814, and HIPAA rules.
• Excellent written and oral communication and project management skills.

Responsibilities

• Reviews and processes protocol submissions, amendments, continuing reviews, and adverse event reports for regulatory compliance.
• Determines review pathway (exempt, expedited, full board) per federal criteria.
• Prepares board meeting materials and records accurate minutes in Cayuse.
• Issues IRB approval letters and continuing review correspondence within deadlines.
• Maintains master tracking for active protocols, expirations, and stipulations.
• Supports investigator education and outreach on IRB submission requirements and GCP guidelines.

Skills

Regulatory compliance

Cayuse proficiency

IRB submissions

FDA regulations

Documentation accuracy

Education

Bachelor's degree in health science or related field

Master's degree in public health or clinical research administration

Tools

Cayuse

eRA Commons

ClinicalTrials.gov

EPIC

MEDITECH

Job description

Sinai Chicago is seeking an experienced IRB Coordinator to manage regulatory administration for MS H-IRB, ensuring compliance with federal rules and institutional policies. The role includes overseeing protocol submissions, approvals, and correspondence using the Cayuse platform, and acting as a liaison among researchers, IRB members, and sponsors.

The ideal candidate has a Bachelor’s degree in a health-related field, 1+ year of IRB or clinical research experience, and strong knowledge of 45 CFR