Clinical Research Associate II (FSP) - Sydney
Core
Managing and monitoring clinical trials to ensure compliance with regulatory requirements and protect study subjects.
Role type
Senior IC clinical research associate (onsite monitoring)
Builds
Clinical trial data integrity and regulatory compliance for healthcare sponsors
Domain
Healthcare / Clinical Research
Required skills
ICH GCP guidelines knowledge, clinical trial monitoring procedures, source data verification, informed consent verification, serious adverse event reporting, site management, travel logistics
Preferred skills
None stated
Technologies
eClinical systems, eTMF, data management systems
Responsibilities
Conduct pre-study, site initiation, routine, and close-out monitoring visits; verify source documents and data accuracy; ensure informed consent and protocol adherence; track investigational product inventory; manage site regulatory documents; prepare monitoring plans and trip reports; assist with investigator recruitment and training.
Seniority
Mid-level, independent execution
