Senior Clinical Research Associate - FSP
Core
Manage assigned clinical trial investigator sites from activation through close-out to ensure patient safety, quality execution, and compliance with GCP and client standards.
Role type
Senior Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical trial data integrity and patient safety outcomes for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Clinical trial monitoring, GCP/ICH regulations, site activation and close-out, adverse event monitoring, protocol deviation management, data query resolution, investigational product management, site recruitment support, audit preparation
Preferred skills
Oncology therapeutic experience, global clinical trial experience, mentorship of junior CRAs
Technologies
Electronic monitoring systems, Trial Master File (TMF) platforms
Responsibilities
Conduct onsite and remote monitoring for site initiation, routine checks, and close-out; manage site relationships and resolve protocol-related issues; monitor and report adverse events; support site recruitment and enrollment; ensure compliance with study protocols and regulations; prepare for and support audits; mentor junior CRAs
Seniority
Senior, hands-on IC with potential mentorship duties
