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Clinical Quality Assurance Specialist
2 weeks ago
We are seeking a seasoned Quality Assurance professional to provide ongoing clinical quality assurance support. This individual will play a pivotal role in guiding study teams, ensuring compliance with Good Clinical Practice (GCP) guidelines and providing quality oversight.
Key Responsibilities:- Deliver QA expertise during study calls, including protocol deviation meetings and risk-based quality management discussions.
- Develop, review and maintain standard operating procedures (SOPs) and quality documentation.
- Manage and track quality processes within the quality management system, including document control and CAPA management.
- Provide timely and actionable guidance on QA-related questions from study teams.
This is a full-time contract role offering 30–40 hours per week of consistent work. The contractor will act as a core member of the QA function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.
Requirements:- Bachelor's degree in life sciences, healthcare or related field (advanced degree preferred).
- 5+ years of experience in Clinical Quality Assurance with a strong foundation in GCP.
- Prior experience supporting clinical study teams in a QA capacity.
- Hands-on experience with quality management systems.
Why this role? As a QA Specialist, you will have the opportunity to make a tangible impact on our clinical programs and contribute to the success of our team.
What we offer: A challenging and rewarding role with opportunities for growth and development, a dynamic and collaborative work environment, and the chance to work on high-profile clinical trials.