
Senior Clinical Research Associate
Há 3 dias
Job Title: Senior Clinical Research Associate
Senior CRA Role Overview
- Clinical monitoring plays a crucial role in ensuring the integrity and quality of clinical research studies. As a senior clinical research associate, you will be responsible for monitoring on-site and remote to ensure that trials are conducted in accordance with widely accepted clinical practices.
- Develop tools, procedures, and processes to guarantee quality monitoring and manage the work of lower-level professionals or manage processes and programs.
Key Responsibilities:
- Evaluate overall site performance and provide recommendations regarding site-specific actions.
- Conduct source document review, verify clinical data accuracy and completeness, and apply query resolution techniques.
Impact and Contribution:
- Ensure regulatory, ICH-GCP, and protocol compliance during site qualification, site initiation, interim monitoring, site management, and close-out visits.
- Verify informed consent process, protect subject/patient confidentiality, and assess factors affecting safety and clinical data integrity.
Core Focus Areas:
- Verify clinical data accuracy and completeness.
- Assess factors affecting subject/patient safety and clinical data integrity.
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