Quality Assurance

The role of quality assurance

Quality assurance provides independent evaluation of clinical research activities, systems, and processes. Teams assess whether work follows applicable requirements, study procedures, and organizational standards.

The work helps organizations identify gaps, address underlying causes, and improve how they maintain participant protection and reliable study data.

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What the work involves

• Supporting audits of study activities, documents, and systems
• Reviewing adherence to procedures and quality standards
• Documenting findings and tracking corrective and preventive actions
• Maintaining quality records and supporting inspection readiness
• Identifying recurring issues and opportunities to improve processes

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Roles within this pathway

Titles and responsibilities vary by employer.

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• Quality Assurance Associate: Supports quality documentation, audit preparation, and follow-up on assigned actions.
• Clinical Quality Assurance Specialist: Evaluates clinical research processes and supports investigations, quality reviews, and improvements.
• GCP Auditor: Conducts audits of research sites, service providers, and study systems. These positions generally require relevant clinical research and audit experience.
• Quality Systems Coordinator: Maintains quality procedures, training records, and systems for tracking issues and corrective actions.

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A pathway for diverse backgrounds

Quality assurance draws on experience across clinical research, healthcare, life sciences, and quality systems. Skills in reviewing evidence, interpreting procedures, and documenting findings provide a relevant foundation for contributing to research quality.

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Accelerate your path into clinical research

Clintern Ascend combines industry training with a remote internship at a clinical research organization (CRO) partner. Gain experience with research workflows, essential documentation, and study requirements, without taking time off work or school.

Dedicated résumé, interview, and career positioning support helps you communicate your experience to employers and pursue your next step with confidence. Independent audit and specialized quality positions typically require additional experience.

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