Clinical Trial Quality Assurance Specialist
9 hours ago
Our organization seeks an experienced Quality Assurance Specialist to provide ongoing clinical quality assurance support across various clinical trials. This individual will play a crucial role in guiding study teams, ensuring compliance with Good Clinical Practice (GCP), and maintaining quality oversight.
Key Responsibilities:- Provide primary QA support for clinical study teams, guaranteeing adherence to GCP and internal quality standards.
- Offer QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, study operations, and trial oversight meetings.
- Develop, review, update, and format standard operating procedures (SOPs) and other quality documentation.
- Manage and track quality processes within a quality management system, including document control, training, and corrective action process 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.
- Education: Bachelor's degree in life sciences, healthcare, or a related discipline.
- Experience:
- 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP.
- Prior experience supporting clinical study teams in a QA capacity.
- Hands-on experience with a quality management system.
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Hyderabad, Telangana, India Imaging Endpoints Full timeSUMMARYImaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind....
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Hyderabad, Telangana, India Imaging Endpoints Full timeSUMMARY Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to...
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