Clinical Research Associate

Overview

In this role you will oversee investigator site management and monitoring for assigned trials, ensuring patient safety, quality, and compliance with GCP and Pfizer standards. You will partner with the Site Care Partner and study team to set up, run, and close sites, addressing protocol questions and supporting enrollment. Your work enhances site performance, data integrity, and Pfizer’s external credibility. This field-based position in the United Kingdom combines hands-on monitoring with cross-functional collaboration and travel.

Responsibilities

• Manage investigator site management and monitoring from initiation to database lock
• Serve as primary site contact; escalate to SCP to ensure delivery quality
• Coordinate with study team, vendors, and sites for smooth information flow
• Develop and coach site personnel on protocol compliance and patient safeguarding
• Attend investigator meetings and support site activation and recruitment efforts
• Perform remote assessments of eDiary data and conduct onsite/remote monitoring as needed
• Monitor AEs/SAEs and coordinate with Drug Safety to resolve reports
• Submit required Trial Master File updates, site reports, deviations, and recruitment metrics on time
• Identify and resolve site issues and implement corrective actions to prevent recurrence
• Ensure oversight of investigational product at sites (receipt, storage, handling, destruction)
• Support database release as needed
• May perform unblinded monitoring where appropriate
• Maintain thorough product/therapeutic area knowledge for QA and safety
• Drive quality event submission and CAPA when applicable
• Act as audit contact and support CAPA processes when relevant

Key requirements

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, or equivalent
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and local regulations
• Monitoring experience in clinical research site monitoring and management
• Preferred: oncology, vaccines, internal medicine or infectious diseases experience
• Global clinical trial experience preferred
• Fluent in English
• Significant travel (60-80%) within area; potential international and weekend travel
• Valid driver’s license and passport
• Remote – Field Based work location in United Kingdom

• Effective communication and relationship management
• Problem-solving and issue resolution
• Collaborative team player
• Knowledge of ICH/GCP and regulatory requirements
• Experience with Study Monitoring Plan and SOP adherence
• Clinical trial site monitoring and management

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