Cra 2
Core
Conduct site monitoring and management for clinical trials, ensuring data integrity, regulatory compliance, and subject protection across various study phases.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data and regulatory compliance for pharmaceutical and medical device sponsors
Domain
Clinical Research / Life Sciences
Required skills
ICH GCP guidelines, clinical monitoring procedures, source data verification, informed consent verification, adverse event tracking, site management, regulatory document management, travel logistics
Preferred skills
Phase I monitoring, e-clinical systems, medical/nursing background, physiology/pharmacology knowledge, CTMS
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 serious adverse events; prepare monitoring plans and trip reports; assist with site recruitment and training.
Seniority
Mid-level, independent IC