Senior Clinical Research Associate/Clinical Research Associate - FSP
Core
Local responsibility for the delivery of clinical studies at allocated sites, ensuring proper study conduct and compliance with international guidelines and local regulations.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical studies for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
ICH-GCP compliance, site monitoring, source data verification, regulatory submission, risk-based quality management, drug accountability, data query resolution, serious adverse event reporting, eTMF management
Preferred skills
Risk-based monitoring approach, cultural awareness, remote collaboration
Technologies
CTMS, eTMF
Responsibilities
Initiate, monitor, and close study sites; perform monitoring visits (remote and onsite) and source data verification; manage study supplies and drug accountability; ensure site inspection readiness; prepare monitoring visit reports; escalate quality issues; collect and upload essential documents to eTMF.
Seniority
Senior, hands-on IC
