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Clinical Research Associate II
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- AtriCure’s Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide.
- The Clinical Research Associate II (CRA II) will be a key contributor to AtriCure’s clinical affairs department and primarily responsible for the site management of assigned clinical investigative sites.
- The CRA II will be responsible for the study start up process for AtriCure’s Clinical Investigational protocols, which includes and is not limited to the following: protocol review, Informed Consent Development, CRF design, EDC testing, preparation of site-specific logs/documentation and investigator study files.
- Assist Clinical Project Managers and Sr. CRAs in the study development and start-up process development of the informed consent form and internal review prior to submission to the IRB/EC.Collection of startup documentation from clinical investigational site
- Comprehensive knowledge of ISO, GCP, ICH, FDA and other applicable regulations governing the conduct of clinical trials
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