Clinical Research Associate - Fsp
Core
Monitors investigator sites using risk-based monitoring to ensure data accuracy, protocol compliance, and regulatory adherence for clinical trials.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research / Pharma
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, data verification (SDR/SDV), ICH-GCP knowledge, site initiation, trial close-out, investigator payment processing
Preferred skills
Medical/therapeutic area knowledge, critical thinking, problem-solving, travel adaptability
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites for compliance and data accuracy; assess investigational product inventory; document observations and escalate deficiencies; initiate and close out clinical trial sites; participate in investigator meetings; provide trial status reports
Seniority
Mid-level, independent execution