Senior Clinical Research Associate I
Pfizer Inc
Pfizer seeks a Senior Clinical Research Associate I to manage and monitor assigned clinical trial investigator sites, ensuring patient safety and regulatory compliance. The role encompasses site oversight from initiation through closeout, protocol adherence, and cross-functional coordination with study teams and site personnel.
Responsibilities
- Conduct site initiation, routine monitoring, and closeout activities in accordance with monitoring plans and SOPs
- Serve as primary contact for assigned investigator sites; manage relationships and resolve protocol-related issues
- Provide protocol training, coaching, and development to site personnel to ensure compliance and patient safety
- Monitor adverse events and serious adverse events; collaborate with Drug Safety Unit on follow-up
- Submit required documentation, reports, and tracking data within established timeframes
Requirements
- Bachelor's degree in life sciences, nursing, pharmacy, or medical background
- Minimum 3 years of clinical research site monitoring experience
- Extensive knowledge of ICH/GCP guidelines, FDA regulations, and clinical trial methodologies
- Fluency in English and native language(s) of assigned country
- Preferred oncology experience of at least 2 years
- Global clinical trial experience
- Advanced knowledge of clinical research and development processes
Vacancy posted 2 days ago
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