Specialist, Quality Assurance

Overview

Support the Quality Assurance Department by monitoring clinical trial quality and compliance across traditional and decentralized sites. The role covers audits, CAPA management, regulatory document review, inspection readiness, and quality systems support.

What you'll do

• Review clinical research sites for patient safety and data integrity.
• Review regulatory binders and clinical documents against GCP standards.
• Execute the annual corporate audit plan and report outcomes.
• Develop, track, and monitor Corrective and Preventive Action plans.
• Support external audits and regulatory inspections.
• Maintain quality systems, compliance trackers, and SOPs.
• Provide quality guidance, training, and consultation to clinical teams.

What you'll need

• Bachelor’s degree.
• At least 2 years of Quality Assurance experience.
• At least 4 years of Clinical Research experience in a compliance or GCP-related role.
• Working knowledge of medical and research terminology.
• Working knowledge of federal regulations and Good Clinical Practice.
• Experience with internal and external audits, including FDA, GCP, and SOP audits.
• Strong communication, organization, computer, and decision-making skills.

Details

• Remote within the United States.
• Up to 35% travel required, including possible international travel.
• Expected pay: $70,000–$90,000 USD per year.