Clinical Research Quality Auditor I — Compliance & CAPA

Stanfordlivetickets; Palo Alto (CA); Hybrid; USD 78,000 - 146,000; Full time

Benefits offered by this job

PTO days 18+

Health benefits

Flexible work options

Tuition assistance

403(b) plan

Wellness programs

Commuter benefits

Job summary

Stanford University School of Medicine is seeking a Quality Assurance Auditor 1 to conduct internal audits of clinical research studies, evaluating compliance with GCP, FDA requirements, and study protocols. The role includes CAPA support, education, and collaboration with investigators across departments, with a hybrid/telecommute option based on operations.

The position emphasizes preparing audit reports, sponsoring inspections, and maintaining quality systems to advance continuous improvement

Qualifications

• 4 years of related experience in clinical research or industry/academia managing complex compliance issues.
• Certification as SCRA or ACRP is preferred.
• Experience with FDA inspections and CAPA processes.

Responsibilities

• Audit clinical research protocols for adherence and regulatory compliance.
• Create audit plans and select source documents for review.
• Review sponsor audit reports and FDA Form 483 responses.
• Prepare audit reports and coordinate CAPA activities.
• Provide inspection-readiness tools and training materials.
• Educate teams on Good Documentation Practices and CAPA planning.
• Collaborate with IRB, Cancer Trials Office, and other Stanford partners.
• Participate in sponsor and regulatory agency audits.

Skills

Auditing

Regulatory compliance

Data analysis

Communication skills

Attention to detail

Tools

SmartSheet

REDCap

Job description

Stanford University School of Medicine is seeking a Quality Assurance Auditor 1 to conduct internal audits of clinical research studies, evaluating compliance with GCP, FDA requirements, and study protocols. The role includes CAPA support, education, and collaboration with investigators across departments, with a hybrid/telecommute option based on operations.

The position emphasizes preparing audit reports, sponsoring inspections, and maintaining quality systems to advance continuous improvement