Clinical Research Associate II
Core
Manage assigned clinical investigative sites for medical device trials, ensuring protocol compliance and study execution from start-up to closure.
Role type
Mid-level Clinical Research Associate (IC)
Builds
Clinical trials for medical devices (cardiovascular/Afib treatments)
Domain
Medical Devices / Clinical Research
Required skills
Clinical trial site management, GCP/ICH/FDA regulations, EDC systems, site training, adverse event reporting, regulatory compliance monitoring
Preferred skills
Medical device trial experience, cardiovascular clinical trial experience, anatomy/physiology knowledge, CCRA/CCRP certification, Registered Nurse background
Technologies
EDC systems, Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Conduct site qualification, initiation, interim, and close-out visits; verify investigator adherence to protocol; manage site enrollment and device accountability; resolve protocol deviations and data queries; train site personnel.
Seniority
Mid-level, hands-on IC