FSP Sr. CRA (Level I)
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and audit readiness for clinical trials in neurology and rare diseases.
Role type
Senior IC clinical research associate (Level I)
Builds
Clinical trial data reliability and regulatory compliance for pharmaceutical and biotech sponsors
Domain
Life sciences / Clinical research / Neurology / Rare diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring, root cause analysis, ICH-GCP compliance, site initiation and close-out, data review (SDR/SDV/CRF), investigator management, travel management
Preferred skills
Therapeutic area knowledge (neurology), rare disease experience, advanced problem-solving
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Conduct on-site and remote monitoring visits to assess protocol and regulatory compliance; Initiate and close out clinical trial sites; Ensure audit readiness and document observations; Track trial status and update study systems; Facilitate communication between sites, clients, and project teams; Respond to regulatory audits and inspections.
Seniority
Senior, hands-on IC