Clinical QA Auditor – Research Compliance (Hybrid)

Yale University; New Haven (CT); Hybrid; USD 68,000 - 121,000; Full time

Job summary

Yale University is seeking a QA Auditor for the Yale Center for Clinical Investigation (YCCI) Quality Assurance Unit. The role conducts clinical research auditing and quality improvement across human subject research at Yale School of Medicine, ensuring compliance with regulations, guidelines, and institutional policies.

Travel to research sites may be required, with flexible audit schedules. The role emphasizes strong regulatory knowledge, experience in auditing, and the ability to train

Qualifications

• Bachelor Degree in related field and five years of related experience or equivalent.
• GCP training within 3 months of hire.
• Demonstrated knowledge of quality assurance auditing and monitoring techniques.

Responsibilities

• Collaborate with Yale leadership, investigators, HRPP and IRB to review human subject research activities for safety, compliance and integrity.
• Evaluate clinical trial conduct to assure research integrity and regulatory compliance with policies and regulations.
• Identify non-compliance and report to YCCI leadership, HRPP, IRB and OGC as needed.
• Provide educational and corrective action guidance to faculty for FDA audits and liaison with FDA during inspections.
• Develop Data and Safety Monitoring Plans and customize audit plans based on risk categories.
• Train staff and researchers, propose quality improvements and corrective action plans.
• Review audit findings, monitor action plans, and identify trends for broader educational needs.
• Integrate QA findings with committees and educational programs to promote safety and compliance.

Skills

ICH GCP

Regulatory knowledge

Attention to detail

Self-directed

multitask / project management

Education

Bachelor degree + 5 years

Master’s degree preferred

SOCRA/ACRP certification

Job description

Yale University is seeking a QA Auditor for the Yale Center for Clinical Investigation (YCCI) Quality Assurance Unit. The role conducts clinical research auditing and quality improvement across human subject research at Yale School of Medicine, ensuring compliance with regulations, guidelines, and institutional policies.

Travel to research sites may be required, with flexible audit schedules. The role emphasizes strong regulatory knowledge, experience in auditing, and the ability to train