OnCore Compliance & Data Integrity Analyst

University of Chicago; Chicago (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

University of Chicago seeks an OnCore Compliance & Monitoring Analyst to uphold regulatory compliance and data integrity within the CTMS OnCore. You will review records, identify discrepancies, and coordinate CAPAs in collaboration with the RSCA unit.

The role partners with study teams and institutional stakeholders, develops monitoring plans, and supports training to promote standardized, compliant research operations across the enterprise. 40 hours weekly, exempt, salaried.

Qualifications

• Minimum 2-5 years of related experience in clinical research compliance.
• Experience with OnCore CTMS and regulatory documentation.
• Familiarity with GCP, FDA regulations, and IRB processes.

Responsibilities

• Monitor clinical research study records for compliance with policies and regulations.
• Reconcile data across CTMS and related systems to ensure accuracy.
• Review lifecycle documentation to identify discrepancies and data quality issues.
• Prepare monitoring reports and CAPAs.
• Communicate findings to study teams and stakeholders.
• Support training and development of monitoring plans and QA metrics.

Skills

Regulatory compliance

Quality assurance

Auditing

Clinical research coordination

Documentation

Education

Bachelor's degree

Tools

OnCore CTMS

Microsoft Office (Word, Excel, PowerPoint, Teams)

Job description

University of Chicago seeks an OnCore Compliance & Monitoring Analyst to uphold regulatory compliance and data integrity within the CTMS OnCore. You will review records, identify discrepancies, and coordinate CAPAs in collaboration with the RSCA unit.

The role partners with study teams and institutional stakeholders, develops monitoring plans, and supports training to promote standardized, compliant research operations across the enterprise. 40 hours weekly, exempt, salaried.