Clinical Research Associate II (FSP) - Melbourne
Core
Manage and monitor clinical trials for sponsors, ensuring regulatory compliance, data integrity, and subject protection across investigative sites.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trial data and regulatory compliance for healthcare sponsors
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
ICH GCP guidelines, clinical trial monitoring, source data verification, informed consent procedures, regulatory document management, investigational product inventory tracking, SAE reporting, site initiation, travel management
Preferred skills
None stated
Technologies
eClinical systems, eTMF, data management systems
Responsibilities
Conduct pre-study, initiation, routine, and close-out site monitoring visits; verify source data and resolve queries; ensure informed consent and protocol adherence; track investigational product inventory; manage site regulatory documents; report and follow up on serious adverse events; prepare monitoring plans and training materials; travel to study sites.
Seniority
Mid-level, hands-on IC