CRA I - FSP - France
Core
Conduct remote and on-site clinical monitoring visits to assess protocol and regulatory compliance, manage documentation, and ensure audit readiness for clinical trials.
Role type
Clinical Research Associate I
Builds
Clinical trials for pharmaceutical and biotech sponsors
Domain
Clinical research / Pharmaceutical industry
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, data accuracy verification (SDR, SDV, CRF review), physical inventory management, regulatory compliance knowledge (ICH-GCP), business writing, issue escalation and resolution
Preferred skills
Investigator meeting participation, site identification and initiation, trial close-out procedures
Technologies
None explicitly stated
Responsibilities
Monitor investigator sites using a risk-based approach to identify failures and implement corrective actions; ensure data accuracy through source data review and case report form review; assess investigational product via physical inventory and records review; document observations and escalate deficiencies to clinical management; initiate clinical trial sites and perform trial close-out; ensure essential trial documents are complete and compliant with ICH-GCP guidelines