Compliance Auditor
Core
Maintains and advances regulatory compliance programs for clinical research operations by conducting audits, monitoring activities, and quality assurance assessments to identify risk and drive continuous improvement.
Role type
Compliance Auditor (Clinical Research)
Builds
Regulatory compliance infrastructure and audit reports for clinical research operations
Domain
Healthcare / Clinical Research / Regulatory Compliance
Required skills
Audit planning and execution, Regulatory interpretation (GCP, 21 CFR, 45 CFR), Study lifecycle documentation review, CAPA tracking, Risk identification and mitigation, Report writing
Preferred skills
Clinical research regulatory compliance experience, CITI Human Subject Protection & GCP training, Knowledge of 21 CFR Parts 11, 50, 54, 56, 312, 812 and 45 CFR 46, ICH GCP guidelines, Electronic IRB systems, ClinicalTrials.gov system
Technologies
Microsoft Office (Word, Excel, PowerPoint, Teams), Electronic IRB systems, Clinical trial management systems, EPIC
Responsibilities
Conduct routine and targeted audits to assess compliance with institutional policies, GCP, and federal/state/local regulations; Review study lifecycle documentation to identify discrepancies and data quality issues; Prepare written audit reports summarizing observations and recommended corrective actions; Track effectiveness of corrective and preventive actions; Provide training to faculty and staff on research compliance topics; Collaborate with stakeholders on cross-division projects for risk mitigation.
Seniority
Mid-level Individual Contributor