FSP Sr. CRA I
Core
Senior Clinical Research Associate monitoring investigator sites to ensure protocol and regulatory compliance, data accuracy, and subject safety across clinical trials.
Role type
Senior IC clinical research associate (monitoring)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/biotech clients
Domain
Life sciences / Clinical trials
Required skills
Clinical trial monitoring, ICH-GCP guidelines, risk-based monitoring, root cause analysis, data review (SDR/SDV/CRF), investigator site management, travel management, CTMS proficiency
Preferred skills
Oncology experience
Technologies
CTMS, Clinical Trial Management Systems
Responsibilities
Conduct remote and on-site monitoring visits to assess protocol and regulatory compliance; ensure data accuracy through source data review and CRF review; manage investigator site initiation, payment, and close-out; escalate and resolve deficiencies; maintain communication between sites, clients, and project teams; perform quality control checks on trial management system reports; ensure audit readiness and document completion.
Seniority
Senior, hands-on IC