Clinical Research Associate – Senior

Role Overview

• Lead site management and monitoring activities across assigned clinical trial sites, ensuring studies are conducted in accordance with protocol, Good Clinical Practice (GCP), regulatory requirements, and Pfizer standards.
• Serve as the primary point of contact for investigator sites, building strong partnerships to support high-quality study delivery and successful trial outcomes.
• Manage site operations from study start-up through closeout, ensuring key milestones, timelines, and quality objectives are achieved.
• Conduct onsite, remote, and risk-based monitoring activities, including site initiation, routine monitoring visits, and closeout visits.
• Partner with Site Care Partners and cross-functional study teams to identify and mitigate risks, resolve site issues, and drive operational excellence.
• Support patient recruitment and enrollment efforts by collaborating with investigators and study teams to address site-level challenges and implement recruitment strategies.
• Provide protocol guidance, training, and coaching to investigator site personnel to ensure compliance, quality execution, and patient safety.
• Develop and maintain strong scientific and operational knowledge of study protocols, investigational products, and therapeutic areas to effectively support investigators and site teams.
• Drive the identification, escalation, and resolution of site quality, compliance, and data integrity issues, including implementation of corrective and preventive actions (CAPAs).
• Monitor and support patient safety activities, including adverse event and serious adverse event reporting and follow-up.
• Ensure timely completion and maintenance of essential study documentation, trial records, and regulatory compliance requirements throughout the study lifecycle.
• Contribute to continuous improvement initiatives by mentoring junior CRAs, sharing best practices, and participating in local and regional process improvement projects.

Requirements

• 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
• Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
• Global clinical trial experience
• Proficiency in English, both written and verbal
• Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
• Valid driver’s license and passport required

Tech Stack

• Google Cloud Platform

Benefits

• Paid parental leave
• Access to Health & Wellness apps
• Career Growth Experiences program
• Recognition & rewards program
• Paid volunteer days
• Life Insurance Benefits
• Pfizer Learning Academy access to top content providers
• Access to flu vaccines & skin checks
• Options to purchase additional leave
• Salary packaging & novated lease options