Clinical Research Compliance Auditor

Biological Sciences Division at the University of Chicago; Chicago (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

The Biological Sciences Division at the University of Chicago is seeking a Compliance Auditor to maintain regulatory compliance programs for clinical research operations. You will interpret systems to identify risk, coordinate internal audits, and prepare formal reports with CAPAs.

With 2–5 years of related experience and knowledge of GCP and IRB processes, you will train staff, monitor trends, and provide SME guidance to investigators.

Qualifications

• Minimum requirements include a college or university degree in related field.
• 2-5 years of work experience in clinical research regulatory compliance, study coordination, quality assurance, monitoring, auditing, or related research activities.
• CITI Human Subject Protection & Good Clinical Practice experience strongly preferred; knowledge of 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH guidelines is preferred.

Responsibilities

• Identify priorities for the HRPP annual research compliance audit plan and conduct routine and targeted audits for policy and regulatory compliance.
• Plan and execute internal audits and monitoring activities to support regulatory inspections.
• Review study lifecycle documents for discrepancies and data quality issues.
• Evaluate adherence to SOPs and processes related to study activation, maintenance, amendments, enrollment, and closure.
• Prepare audit reports, track CAPAs, and communicate findings to investigators and stakeholders.
• Monitor corrective action plans and assess intervention effectiveness.
• Provide training to faculty and staff on research compliance topics.
• Collaborate on cross-division projects to increase efficiencies and risk mitigation.
• Support ClinicalTrials.gov and coordinate compliance documentation and meetings.

Skills

Communication skills

Analytical skills

Organization

Project management

Education

Bachelor's degree in related field

Tools

Microsoft Office

Electronic IRB systems

Clinical trial management systems

Job description

The Biological Sciences Division at the University of Chicago is seeking a Compliance Auditor to maintain regulatory compliance programs for clinical research operations. You will interpret systems to identify risk, coordinate internal audits, and prepare formal reports with CAPAs.

With 2–5 years of related experience and knowledge of GCP and IRB processes, you will train staff, monitor trends, and provide SME guidance to investigators.