CRA (Level II) - FSP
Core
Clinical Research Associate responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies to ensure proper delivery and compliance.
Role type
Junior Clinical Research Associate (CRA)
Builds
Clinical studies at allocated sites
Domain
Healthcare / Clinical Research
Required skills
Site monitoring, Source Data Verification (SDV), Case Report Form (CRF) review, Regulatory document management, Risk Based Quality Management (RBQM), Data query resolution, Serious Adverse Event reporting, eTMF management, Drug accountability
Preferred skills
Experience with LSAD tasks, National Investigators meetings, Collaboration with MSLs
Technologies
CTMS, eTMF
Responsibilities
Perform monitoring visits (remote and on-site), conduct Source Data Review and verification, manage study supplies and drug accountability, ensure inspection readiness, update clinical trial systems, report Serious Adverse Events, prepare monitoring visit reports, support audits and regulatory inspections.
Seniority
Junior, 0-2 years experience
