Clinical Trials QA Auditor & Compliance Specialist

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

Job summary

Yale University in New Haven seeks a Quality Assurance Audit Manager to lead clinical research auditing and quality-improvement efforts for human subject research in the Yale School of Medicine. You will ensure compliance with ICH-GCP, federal regulations, and university policies, guiding investigators and study teams through audits and corrective actions.

The role requires strong regulatory knowledge, experience in auditing or monitoring, and the ability to collaborate with YCCI leadership,

Qualifications

• Knowledge of ICH GCP and federal regulations governing human subject research.
• Ability to work independently, plan, research and manage multiple projects.
• Experience communicating with diverse stakeholders and handling confidential data.

Responsibilities

• Lead QA audits and quality improvement for human subject research.
• Identify non-compliance and report to leadership and regulatory bodies.
• Develop and deliver training on safety and compliance for study teams.
• Coordinate with investigators, HRPP, IRB, and FDA during inspections and audits.

Skills

ICH GCP guidelines

Federal Regulations

Detail orientation

Confidential data handling

Interpersonal communication

Education

Bachelor degree in related field

GCP training

SOCRA/ACRP certification

Job description

Yale University in New Haven seeks a Quality Assurance Audit Manager to lead clinical research auditing and quality-improvement efforts for human subject research in the Yale School of Medicine. You will ensure compliance with ICH-GCP, federal regulations, and university policies, guiding investigators and study teams through audits and corrective actions.

The role requires strong regulatory knowledge, experience in auditing or monitoring, and the ability to collaborate with YCCI leadership,