Senior Clinical Research Associate II

Overview

Senior Clinical Research Associate II drives site management, monitoring and close-out to ensure patient safety and study quality within Pfizer standards. You’ll work with cross-functional teams to support trial execution, site development and issue resolution, enabling compliant and efficient trials. The role blends hands-on monitoring with stakeholder collaboration to uphold data integrity and regulatory compliance in a global context. You will contribute to Pfizer’s patient-centric mission by guiding sites through activation, conduct, and close-out.

Pay / Benefits

• remote work
• flexible workplace culture
• significant travel opportunities
• opportunity to work on global clinical trials
• Pfizer values-driven culture
• professional growth and mentoring

Responsibilities

• Oversee investigator site management and monitoring from activation to database lock to meet timelines and quality standards
• Act as primary site contact during study conduct and escalate to SCP for site delivery quality
• Coordinate information flow between study team, vendors, and investigator sites
• Partner with SCP to train and coach site personnel for protocol adherence and patient safeguarding
• Attend investigator meetings as required and support enrollment and recruitment at sites
• Perform on-site, remote, or electronic monitoring per the Study Monitoring Plan and SOPs
• Monitor AEs/SAEs and liaise with Drug Safety Unit to resolve reports
• Submit required Trial Master File, site reports, deviations, recruitment metrics, and supply management updates within deadlines
• Identify and resolve investigator site issues; develop corrective and preventive actions to prevent recurrence
• Manage data queries and plan/execute investigator site close-out activities
• Oversee investigational product handling at sites, including receipt, storage, and destruction
• May assume unblinded monitoring duties when appropriate
• Maintain understanding of product, protocol, and therapy area to discuss with investigators
• Support sponsor regulatory interactions and inspections via CAPA development and checks
• Mentor/train CRAs and Sr CRAs as assigned
• May serve as SME on related initiatives/planning

Key requirements

• Bachelor’s degree in life sciences or professional degree in life sciences (nursing, pharmacy, medical background) or equivalent
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local regulations
• Minimum 3 years of clinical research site monitoring experience ( Oncology experience preferred)
• Global clinical trial experience
• Fluency in English and local language(s) where applicable
• Strong communication and collaboration skills
• Ability to travel 60–80% (and some international travel)
• Demonstrated ability to work in a matrix environment and drive/sponsor risk management

• communication
• collaboration
• problem solving
• clinical trial monitoring
• GCP/ICH compliance
• SAE/AEs management and pharmacovigilance liaison

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