Clinical Research Compliance Auditor: Elevate QA & Risk

University of Chicago; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

The University of Chicago is seeking a Compliance Auditor within the HRPP to maintain regulatory compliance programs, conduct audits, monitor activities, and prepare formal reports. You will track CAPAs, findings, and training needs while serving as a subject matter resource on research compliance.

With moderate direction, you will contribute to documentation, training, and committee activities, collaborating with clinical researchers and stakeholders to improve risk mitigation and efficiency.

Qualifications

• Degree in a related field required.
• 2–5 years of related work experience.
• Certification by Clinical Research Professional Organizations (SQA, SOCRA, ACRP) preferred.
• CITI Human Subject Protection & Good Clinical Practice experience strongly preferred.
• Experience with electronic IRB systems and EPIC familiarity preferred.

Responsibilities

• Assist in identifying priorities for HRPP annual audit plan and conduct routine audits.
• Plan and execute internal audits and monitoring to support regulatory inspections.
• Review study lifecycle documents for discrepancies and data quality.
• Evaluate adherence to SOPs for activation, maintenance, amendments, enrollment, and closures.
• Prepare audit reports with observations, risks, and CAPAs.
• Track corrective actions and assess effectiveness.
• Communicate findings to PIs and study teams with remediation guidance.
• Collaborate across divisions on cross-division projects focused on efficiency and risk mitigation.

Skills

MS Office

Organizational skills

Project management

Electronic IRB systems

EPIC familiarity

ClinicalTrials.gov

Education

Bachelor's degree in related field

2-5 years regulatory/compliance experience

Tools

Electronic IRB systems

EPIC

ClinicalTrials.gov

Job description

The University of Chicago is seeking a Compliance Auditor within the HRPP to maintain regulatory compliance programs, conduct audits, monitor activities, and prepare formal reports. You will track CAPAs, findings, and training needs while serving as a subject matter resource on research compliance.

With moderate direction, you will contribute to documentation, training, and committee activities, collaborating with clinical researchers and stakeholders to improve risk mitigation and efficiency.