Clinical Research Associate II
Core
Conduct on-site clinical monitoring for trials, ensuring data integrity, regulatory compliance, and subject protection across study sites.
Role type
Clinical Research Associate II (IC)
Builds
Clinical trial data and regulatory compliance for sponsors
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ICH GCP guidelines, clinical trial monitoring procedures, source data verification, informed consent verification, adverse event tracking, eClinical systems, travel management
Preferred skills
Phase I monitoring, nursing or life science background, CTMS experience, medical device terminology
Technologies
eClinical systems, CTMS, Microsoft Office
Responsibilities
Conduct pre-study, initiation, routine, and close-out site monitoring visits; verify source documents and resolve queries; ensure informed consent and protocol adherence; track investigational product inventory; manage travel and submit trip reports; monitor serious adverse events; assist with site recruitment and training.
Seniority
Mid-level, hands-on IC