Clinical Research Compliance & Monitoring Analyst

University of Chicago; Chicago (IL); On-site; USD 70,000 - 110,000; Full time

Job summary

The University of Chicago Office of Clinical Research seeks an OnCore Compliance & Monitoring Analyst to help ensure regulatory compliance and data quality across the Clinical Trial Management System (OnCore). This role supports internal audits, CAPAs, and continuous quality improvement within the RSCA unit.

Working with study teams and institutional stakeholders, you will review records, identify discrepancies, and guide remediation, training, and best practices to promote compliant research

Qualifications

• Minimum requirements include a college or university degree in a related field.
• 2–5 years of work experience in a related discipline.
• Knowledge of regulatory compliance frameworks and clinical research principles.

Responsibilities

• Conduct routine and targeted monitoring of clinical research study records for compliance with policies and regulations.
• Reconcile clinical research data across CTMS and related systems to ensure accuracy and data integrity.
• Review study documentation (approvals, amendments, enrollment, protocols) for discrepancies and data quality issues.
• Assess adherence to SOPs and processes for activations, maintenance, amendments, enrollment, and closures.
• Document monitoring findings and prepare reports with CAPA recommendations and remediation guidance.
• Collaborate with Research Compliance, HRPP, and stakeholders to promote consistent research practices.

Education

Bachelor's degree in related field

Master's degree preferred

Job description

The University of Chicago Office of Clinical Research seeks an OnCore Compliance & Monitoring Analyst to help ensure regulatory compliance and data quality across the Clinical Trial Management System (OnCore). This role supports internal audits, CAPAs, and continuous quality improvement within the RSCA unit.

Working with study teams and institutional stakeholders, you will review records, identify discrepancies, and guide remediation, training, and best practices to promote compliant research