Sr Clinical Research Monitor (CRA)
Core
Sponsor representative overseeing clinical trial execution at investigational sites from start-up through closeout for medical device therapies.
Role type
Senior Clinical Research Monitor (CRA)
Builds
Clinical evidence supporting safe and effective use of medical device therapies
Domain
Healthcare / Medical Devices / Clinical Research
Deliverable
physical/clinical work
Required skills
Site monitoring, GCP compliance, Protocol adherence, Source data review, Adverse event management, Site start-up support, Investigator relationship management, Patient recruitment support
Preferred skills
Medical device trial monitoring, Risk-based monitoring, Mentoring CRAs, Australian regulatory knowledge
Technologies
CTMS, EDC, Microsoft Office
Responsibilities
Lead site qualification, initiation, interim, and closeout monitoring visits; Ensure compliance with protocols, GCP, and regulations; Review source documentation and data integrity; Support site feasibility and activation; Train investigators on protocol requirements; Drive patient recruitment and retention.
Seniority
Senior, hands-on IC