Senior Clinical Research Associate I
Core
Manage investigator sites for clinical trials to ensure patient safety, quality execution, and compliance with GCP and Pfizer standards.
Role type
Senior Clinical Research Associate (Site Monitoring)
Builds
Clinical trial data integrity and patient safety outcomes
Domain
Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial monitoring, GCP/ICH/FDA regulations, site initiation through close-out management, protocol deviation resolution, AE/SAE monitoring, investigational product handling, audit support, recruitment support, data query resolution, corrective and preventative action (CAPA) development, mentorship of junior CRAs
Preferred skills
Oncology therapeutic experience, global clinical trial experience, vaccines/internal medicine/infectious diseases
Technologies
Trial Master File, electronic monitoring systems, remote monitoring tools
Responsibilities
Conduct onsite and remote monitoring for site initiation, routine checks, and close-out; serve as primary contact for investigator sites; support enrollment and recruitment initiatives; monitor and resolve protocol deviations and data queries; ensure proper handling and storage of investigational products; support audit activities and drive CAPA; mentor Clinical Research Associates; facilitate communication between study team, vendors, and sites
Seniority
Senior, hands-on IC