Clinical Research Quality Auditor I — Compliance & CAPA

Stanford University School of Medicine; Palo Alto (CA); Hybrid; USD 95,000 - 130,000; Full time

Job summary

Stanford University School of Medicine is seeking a Quality Assurance Auditor 1 to conduct internal audits of clinical research studies and promote regulatory compliance across the enterprise. The role partners with investigators and teams to implement CAPAs and educate on quality systems, with involvement in sponsor audits and external inspections.

The position is based in Stanford’s Research Park with a telecommuting/hybrid schedule available, supporting ongoing continuous improvement in

Qualifications

• Bachelor’s degree is required.
• 4 years of related experience with 2 years in clinical research managing compliance issues.
• Auditing ability and reporting on internal and external quality systems.
• Knowledge of clinical research regulations including GCP.

Responsibilities

• Audit clinical research protocols to identify potential issues of adherence and regulatory compliance.
• Review protocol documents to create audit plans and select source documents for audit.
• Collect data and backup documents to determine compliance with protocol and regulatory requirements.
• Identify quality issues/non-conformance and coordinate CAPAs with study teams.
• Support inspection readiness and provide training materials for quality improvement.
• Collaborate with IRB and study teams to strengthen regulatory compliance.

Skills

Clinical QA audits

FDA regulations

ICH-GCP

HIPAA

Human subjects protection

Investigator-initiated studies audits

Sponsor audits

FDA inspections

Organization & timeliness

Certification: ACRP/SOCRA/CQA

Education

Bachelor's degree

Tools

SmartSheet

REDCap

SOP knowledge

Job description

Stanford University School of Medicine is seeking a Quality Assurance Auditor 1 to conduct internal audits of clinical research studies and promote regulatory compliance across the enterprise. The role partners with investigators and teams to implement CAPAs and educate on quality systems, with involvement in sponsor audits and external inspections.

The position is based in Stanford’s Research Park with a telecommuting/hybrid schedule available, supporting ongoing continuous improvement in