Clinical Research QA Auditor I

Stanford University School of Medicine; Palo Alto (CA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Stanford University School of Medicine seeks a Quality Assurance Auditor to conduct internal audits of clinical research studies, ensuring compliance with FDA, GCP, and institutional policies. The role involves coordinating audits, preparing reports, and supporting CAPA activities.

You'll collaborate with investigators and teams, provide education on documentation practices, and help prepare for sponsor audits and regulatory inspections.

Qualifications

• Experience conducting clinical research quality assurance or regulatory audits in academia or healthcare.
• Knowledge of FDA regulations, ICH GCP, HIPAA, and human subject protection.
• Experience auditing investigator-initiated and industry-sponsored studies.
• Experience supporting sponsor audits, FDA inspections, or other regulatory inspections.
• Strong organizational skills to manage multiple concurrent audits and deadlines.
• Certification such as ACRP, SOCRA, or CQA is preferred.

Responsibilities

• Audit clinical research protocols to identify potential compliance issues.
• Review protocol documents to create audit plans and select files for review.
• Collect data to verify adherence to regulatory requirements.
• Identify quality issues and coordinate CAPA actions with study teams.
• Maintain an organized system for tracking information (e.g., SmartSheet or REDCap).
• Guide sponsors and investigators to meet IND/IDE responsibilities when needed.
• Participate in preparing for FDA audits and external inspections.
• Provide training on audit readiness and quality improvement practices.

Skills

Analytical skills

Interpersonal skills

Written communication

Oral communication

Audit execution

Quality systems

Education

Bachelor's degree

Tools

SmartSheet

REDCap

Job description

Stanford University School of Medicine seeks a Quality Assurance Auditor to conduct internal audits of clinical research studies, ensuring compliance with FDA, GCP, and institutional policies. The role involves coordinating audits, preparing reports, and supporting CAPA activities.

You'll collaborate with investigators and teams, provide education on documentation practices, and help prepare for sponsor audits and regulatory inspections.