Clinical Research Associate II
Core
Ensures compliance of study conduct by monitoring clinical site activities and managing site relationships for ophthalmic drug and device trials.
Role type
Mid-level Clinical Research Associate (IC)
Builds
Clinical trial data integrity and regulatory compliance for ophthalmic therapies
Domain
Healthcare / Clinical Research / Ophthalmology
Required skills
ICH-GCP compliance, site monitoring, protocol adherence, source data verification, regulatory documentation management, CTMS/eTMF proficiency, travel management
Preferred skills
Ophthalmic clinical trial experience, multilingual communication
Technologies
CTMS, eTMF, EDC, Excel
Responsibilities
Conduct remote and on-site monitoring visits (initiation, interim, close-out), verify source data against reported data, manage site readiness and selection, collect regulatory documentation, communicate with investigators on protocol deviations and performance, resolve site compliance issues, travel up to 75%.
Seniority
Mid-level, hands-on IC