Remote Clinical Research Compliance Auditor

Care2Prevent; Chicago (IL); Remote; USD 65,000 - 90,000; Full time

Job summary

The University of Chicago's Human Research Protections Program seeks a Compliance Auditor to maintain regulatory compliance across clinical research operations. The role includes audits, monitoring activities, and preparing formal reports to identify risk and drive improvements.

With 2–5 years of related experience, you will analyze protocols, ensure GCP compliance, and train staff. Remote work options with on-site Chicago collaboration and a strong emphasis on policy interpretation and

Qualifications

• 2-5 years of work experience in clinical research regulatory compliance or related field.
• CITI Human Subject Protection & Good Clinical Practice experience preferred.
• Advanced knowledge of regulations governing human research (21 CFR Parts 11, 50, 54, 56, 312, 812; 45 CFR 46; ICH GCP).
• Certification by SQA, SOCRA, or ACRP is preferred.
• Proficiency with Microsoft Office applications.
• Experience with electronic IRB systems.

Responsibilities

• Identify priorities for the HRPP annual audit plan and conduct routine and targeted audits.
• Plan and execute internal audits and monitoring to support inspections.
• Review study lifecycle documentation to identify discrepancies and data quality issues.
• Evaluate adherence to SOPs for activation, maintenance, amendments, enrollment, and closure.
• Prepare audit reports with observations, risk areas, and CAPAs.
• Track corrective actions and monitor effectiveness of interventions.
• Communicate findings to investigators and study teams with remediation steps.
• Contribute to monitoring plans, review methodologies, and QA metrics.
• Provide training on research compliance topics and support committee activities.
• Collaborate on cross-division projects and support ClinicalTrials.gov.

Skills

Analytical skills

Organizational skills

Report writing

Interpersonal communication

Education

Bachelor's degree in related field

Tools

Microsoft Office

EPIC

Electronic IRB systems

ClinicalTrials.gov

Job description

The University of Chicago's Human Research Protections Program seeks a Compliance Auditor to maintain regulatory compliance across clinical research operations. The role includes audits, monitoring activities, and preparing formal reports to identify risk and drive improvements.

With 2–5 years of related experience, you will analyze protocols, ensure GCP compliance, and train staff. Remote work options with on-site Chicago collaboration and a strong emphasis on policy interpretation and