FSP CRA II
Core
Coordinates clinical monitoring and site management for global clinical trials, ensuring protocol and regulatory compliance through remote and on-site visits.
Role type
Senior IC Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Audit readiness
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management System (CTMS) proficiency, Process improvement
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; Conduct on-site and remote monitoring visits; Initiate and close out clinical trial sites; Ensure audit readiness and document completeness; Track trial status and generate progress reports; Facilitate communication between sites, clients, and project teams.
Seniority
Mid-level, hands-on IC