Senior CRA
Core
Senior Clinical Research Associate leading site monitoring and study oversight for a non-invasive neuromonitoring technology in hospital environments.
Role type
Senior sponsor-side CRA (medical devices)
Builds
Clinical studies for brain disorder diagnosis and treatment
Domain
Medical devices / Neurology / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP, ICH, FDA regulations, source data verification, protocol adherence monitoring, IRB coordination, EDC/eTMF/CTMS proficiency, site relationship management
Preferred skills
Medical device background, early feasibility/NSR/IDE study experience, neurology/ICU clinical settings familiarity
Technologies
EDC, eTMF, CTMS
Responsibilities
Conduct qualification, initiation, interim, and close-out monitoring visits; perform source data review and query resolution; identify and escalate site issues/deviations; prepare and track IRB submissions; maintain Trial Master File quality; manage IP logistics and accountability documentation
Seniority
Senior, hands-on IC
