Clinical Research Associate II
Core
Initiate and independently oversee clinical centers to ensure successful conduct of active clinical studies for an FDA-approved medical device treating Obstructive Sleep Apnea.
Role type
Clinical Research Associate
Builds
Clinical trials for sleep apnea medical devices
Domain
Medical devices / Clinical Research
Deliverable
physical/clinical work
Required skills
Clinical study protocol knowledge, Regulatory standards compliance, Site qualification, Training, Monitoring, Data collection, IRB/EC submission support, Travel
Preferred skills
None stated
Technologies
None stated
Responsibilities
Identify and assess suitability of clinical study centers; Serve as primary point of contact for study sites and investigators; Train clinical centers on protocol and data collection; Communicate with centers to maximize enrollment and ensure data quality; Perform remote and on-site monitoring visits; Document site visits with reports; Facilitate team communication; Assist with IRB/EC submissions.
