Sr CRA level I
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for pharmaceutical and biotech clinical trials.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance for sponsors
Domain
Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, ICH-GCP knowledge, regulatory compliance, data accuracy verification, site management, audit readiness, investigator identification, trial close-out
Preferred skills
Medical/therapeutic area knowledge, Microsoft Office proficiency, presentation skills
Technologies
Clinical Trial Management System (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; review source documents and case report forms for data accuracy; manage investigator payments and initiate new trial sites; conduct on-site file reviews and ensure essential document completeness; track trial status and update study systems; facilitate communication between sites, clients, and project teams; respond to audits and inspections.
Seniority
Senior, hands-on IC