Senior Clinical Research Associate/Clinical Research Associate - All US Locations - FSP
Core
Monitoring clinical studies at allocated sites to ensure proper delivery, compliance with ICH-GCP, and timely resolution of study-related issues.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and site compliance for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
ICH-GCP compliance, source data verification (SDV), case report form (CRF) review, site initiation and closure, serious adverse event reporting, regulatory document management, risk-based quality management (RbQM), CTMS data entry, drug accountability management
Preferred skills
Remote monitoring experience, therapeutic area knowledge, cultural awareness, change management, process improvement
Technologies
CTMS, eTMF
Responsibilities
Perform onsite and remote monitoring visits, conduct source data verification and case report form reviews, manage study supplies and drug accountability, ensure site inspection readiness, resolve data queries, report serious adverse events, prepare monitoring visit reports, coordinate with local study teams and medical science liaisons
Seniority
Senior, hands-on IC
