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Canada Advanced Clinical Full timeThe Senior Clinical Research Associate (Sr. CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH E6 Good Clinical Practices, FDA guidelines, local regulations and standard operating procedures. Responsible for performing the clinical monitoring aspect of designated projects in accordance...
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Canada Advanced Clinical Full timeThe Senior Clinical Research Associate (Sr. CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH E6 Good Clinical Practices, FDA guidelines, local regulations and standard operating procedures. Responsible for performing the clinical monitoring aspect of designated projects in accordance...
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Senior CRA
1 week ago
About the Position: As a Senior CRA - Clinical Trials Site Manager at Advanced Clinical, you will be responsible for managing all aspects of clinical monitoring and site management. This includes conducting qualification, initiation, monitoring, and termination visits of investigational sites in accordance with ICH GCP guidelines.
Your Key Responsibilities:
- Clinical Monitoring: Perform on-site monitoring activities, such as reviewing consent forms, verifying source data, and collecting regulatory documentation.
- Site Management: Conduct qualification, initiation, monitoring, and termination visits of investigational sites.
- Documentation: Maintain regulatory documentation, ensuring compliance with ICH GCP guidelines.
- Team Collaboration: Collaborate with cross-functional teams to ensure successful project execution.
Requirements: A minimum of 4-5 years of clinical monitoring experience, including strong start-up experience, and a BA/BS or RN degree are required for this role.