FSP Senior CRA I - U.S. Northeast Region - Multiple Therapies
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 Clinical Research Associate (CRA)
Builds
Clinical trial monitoring and site management processes
Domain
Clinical Research / Life Sciences
Required skills
Clinical trial monitoring, ICH-GCP guidelines, risk-based monitoring, root cause analysis, data review (SDR/SDV/CRF), investigator site management, regulatory compliance, travel management
Preferred skills
Oncology experience
Technologies
CTMS, Clinical Trial Management Systems
Responsibilities
Monitor investigator sites using risk-based approach; ensure data accuracy through document review; conduct on-site and remote monitoring visits; manage investigator payments and site initiation; ensure audit readiness and document completeness; track trial status and progress; facilitate communication between sites, clients, and project teams; perform quality control checks on reports.
Seniority
Senior, hands-on IC