FSP Sr CRA (Level I)
Core
Senior Clinical Research Associate conducting risk-based on-site and remote monitoring to ensure protocol compliance, data accuracy, and subject safety across clinical trials.
Role type
Senior IC clinical research associate (monitoring)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotech sponsors
Domain
Clinical research / Life sciences
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, audit readiness, investigator management, travel management
Preferred skills
Rare diseases experience, Alzheimer's clinical trials experience, Registered Nursing certification
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Conduct on-site and remote monitoring visits to assess protocol and regulatory compliance; Perform source data verification (SDV) and case report form (CRF) review; Initiate and manage clinical trial sites; Ensure audit readiness and document observations; Manage investigator payments and trial close-out; Respond to regulatory audits and inspections.
Seniority
Senior, hands-on IC