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4 days ago
Job Title: Quality Assurance Specialist
Position Overview:We are seeking an experienced Clinical Quality Assurance expert to provide day-to-day clinical quality assurance support across ongoing clinical trials.
Key Responsibilities:- Provide QA expertise during study calls, including protocol deviation meetings and risk-based quality management discussions.
- Write, review, update and format standard operating procedures (SOPs) and other quality documentation.
- Manage and track quality processes within a clinical trial management system, including document control, training and CAPA management.
- Address QA-related questions from study teams in real-time, providing clear and actionable guidance.
- Support inspection readiness and contribute to continuous improvement of QA systems and processes.
- Bachelor's degree in life sciences, healthcare or related discipline.
- 5+ years of Clinical Quality Assurance experience with a strong foundation in Good Clinical Practice (GCP).
- Prior experience supporting clinical study teams in a QA capacity.
- Hands-on experience with clinical trial management software.
This is a full-time contract role offering consistent work hours. The contractor will act as a core member of the QA function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.
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