Senior Clinical Research Associate
Core
Monitor clinical trial investigator sites to ensure compliance with protocols and regulations, ensuring data accuracy and patient safety.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trials for top 50 pharmaceutical companies and 750+ biotechs
Domain
Life Sciences / Clinical Research / Pharmaceutical
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, data accuracy verification (SDR/SDV/CRF), regulatory compliance (FDA/ICH GCP), site initiation and close-out, investigator identification, mentoring
Preferred skills
Medical terminology proficiency, process improvement, presentation skills
Technologies
Clinical Trial Management System (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches; ensure data accuracy through document review; initiate and close out clinical trial sites; conduct on-site file reviews; mentor new team members; track trial status and provide progress reports; facilitate communication between sites, clients, and project teams.
Seniority
Senior, hands-on IC