FSP CRA (Level II)
Core
Monitors clinical trial investigator sites using a risk-based approach to ensure compliance with protocols and regulations, verify data accuracy, and resolve site deficiencies.
Role type
Level II Clinical Research Associate (CRA)
Builds
Clinical trial sites and data integrity for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
risk-based monitoring, root cause analysis, data verification (SDR/SDV), regulatory compliance (ICH-GCP), site initiation, file review, issue escalation
Preferred skills
problem-solving, business writing, stakeholder communication
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites for compliance and data accuracy, assess investigational product inventory, initiate and close out clinical trial sites, conduct on-site file reviews, track trial status and progress, respond to audits and inspections
Seniority
Mid-level, hands-on IC