Clinical Research Compliance Auditor

The University of Chicago; United States; Remote; USD 65,000 - 90,000; Full time

Job summary

The University of Chicago is seeking a Compliance Auditor within the HRPP to maintain regulatory programs for clinical research operations. You will conduct audits, prepare reports, track CAPAs, and provide training and guidance to investigators and study teams.

With 2–5 years in clinical research regulatory compliance and a solid understanding of GCP and 21 CFR rules, you will help drive continuous improvement and ensure adherence to institutional policies and external regulations.

Qualifications

• Bachelor's degree in a related field.
• 2–5 years of work experience in a related discipline.
• Certification by Clinical Research Professional Organizations preferred.

Responsibilities

• Assists in prioritizing HRPP audit plan and conducts routine and targeted audits for policy and regulatory compliance.
• Plans and executes internal audits and monitoring activities to support regulatory inspections.
• Reviews study lifecycle documentation to identify discrepancies and data quality issues.
• Prepares written audit and investigation reports with observations and CAPAs.
• Communicates findings to investigators and stakeholders with remediation guidance.
• Tracks and trends research compliance investigations and outcomes.

Skills

Analytical thinking

Organizational skills

Report writing

Interpersonal communication

Project management

Microsoft Office

Electronic IRB systems

Education

Bachelor's degree in related field

Tools

Electronic IRB systems

EPIC

Job description

The University of Chicago is seeking a Compliance Auditor within the HRPP to maintain regulatory programs for clinical research operations. You will conduct audits, prepare reports, track CAPAs, and provide training and guidance to investigators and study teams.

With 2–5 years in clinical research regulatory compliance and a solid understanding of GCP and 21 CFR rules, you will help drive continuous improvement and ensure adherence to institutional policies and external regulations.