Senior Clinical Research Associate

• Manage investigator site relationships and assigned clinical trial sites
• Monitor clinical trials according to the Study Monitoring Plan, applicable laws, Good Clinical Practices and Pfizer standards
• Manage clinical trial activities from site initiation through database lock
• Serve as primary contact for assigned investigator sites
• Facilitate information flow among study team members, vendors and investigator sites
• Coach and train site personnel and provide protocol training
• Support enrollment and resolve site activation and recruitment issues
• Conduct onsite and remote/electronic monitoring for initiation, routine monitoring and closure
• Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
• Submit Trial Master File documentation, site reports, protocol deviations, recruitment updates, supply management and study metrics
• Identify and resolve site issues and develop corrective and preventative actions
• Resolve data queries and conduct site close-out activities
• Oversee investigational product receipt, handling, accounting, storage and destruction
• Support database release and undertake unblinded monitor responsibilities when required
• Maintain product, protocol and therapy-area knowledge
• Support patient safety, eligibility and clinical guidance
• Drive Quality Event remediation and support audit observation CAPA activities

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
• Minimum 3 years relevant experience in clinical research site monitoring
• Preferably 2 years in Oncology
• Global clinical trial experience
• Fluent in English and in the native language(s) of the country they will work in
• Valid driver’s license and passport required
• Significant travel (60-80%) within area
• May require some international travel and weekend travel

• Flexible workplace culture supporting work-life harmony
• Reasonable adjustments for disability inclusion
• Equal employment opportunities
• Significant travel opportunities within the assigned area
• Pfizer patient-centric and breakthrough culture