FSP Sr CRA I
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and regulatory compliance for clinical trials in neurology, oncology, rare disease, and pediatric domains.
Role type
Senior IC Clinical Research Associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research / Pharma & Biotech
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP knowledge, site initiation, data review (SDR/SDV/CRF), audit readiness, investigator management
Preferred skills
Neurology or oncology monitoring experience, rare disease or pediatric experience
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Conduct on-site and remote monitoring visits to assess protocol and regulatory compliance; Initiate and manage clinical trial sites; Ensure audit readiness and document observations; Track trial status and update study systems; Respond to regulatory requirements and audits; Manage investigator payments and close-out procedures
Seniority
Senior, hands-on IC