Senior Clinical Research Associate I

About the role

Pfizer is looking for a Senior Clinical Research Associate I to manage, monitor and close out assigned clinical trial investigator sites. The role ensures patient safety and quality study execution in line with applicable laws, Good Clinical Practice and Pfizer standards, and works closely with the Site Care Partner and the wider study team.

Key responsibilities

• Manage assigned sites from initiation through database lock, acting as the primary contact and escalating to the Site Care Partner as needed
• Conduct onsite, remote and electronic monitoring in line with the Study Monitoring Plan, SOPs and emerging technologies
• Support site activation and recruitment, and partner with the Site Care Partner on site development, coaching and training of site personnel
• Monitor site-level AEs and SAEs and work with the Drug Safety Unit to resolve SAE reports
• Submit reports, documentation and tracking on time, including Trial Master File records, site reports, protocol deviations and clinical supply management
• Resolve site issues and data queries, develop corrective and preventative actions, and prepare and run close-out plans
• Oversee investigational product handling, storage and destruction, and support database release; may act as an unblinded monitor
• Support audit observations, CAPA development and checks, and provide clinical guidance to investigators

Required profile

• Bachelor's degree in life sciences or a professional degree such as nursing, pharmacy or medicine, or equivalent
• Minimum 3 years of clinical research site monitoring experience (preferably 2 years in oncology)
• Preferred experience in oncology, vaccines, internal medicine or infectious diseases, and global clinical trial experience
• Fluent English and fluency in the native language of the country of work
• Significant travel (60-80%) within the area, possible international and weekend travel; valid driver's licence and passport required

Required skills

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
• Understanding of the product, protocol and therapy area