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Senior Clinical Research Associate II

Pfizer Inc

Senior Clinical Research Associate II manages clinical trial sites for Pfizer, overseeing site monitoring, investigator relationships, and regulatory compliance. The role ensures patient safety and protocol adherence from site initiation through database lock and study closeout.

Responsibilities

  • Conduct site monitoring and oversight from initiation through database lock and closeout
  • Serve as primary contact for assigned investigator sites and resolve protocol-related issues
  • Develop, coach, and train site personnel on protocol compliance and patient safety
  • Monitor adverse events/serious adverse events and coordinate follow-up with investigators
  • Mentor junior Clinical Research Associates and serve as subject matter expert for CRA processes

Requirements

  • Bachelor's degree in life sciences, nursing, pharmacy, or medical field
  • Minimum 5 years clinical research site monitoring experience
  • Extensive knowledge of ICH/GCP, FDA regulations, and clinical trial methodologies
  • Fluency in English and native language(s) of assigned country
  • Global clinical trial experience preferred
  • Oncology, Vaccines, Internal Medicine, or Infectious Diseases therapeutic experience preferred
Vacancy posted 2 days ago
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