Looking for a 2 RCRA that has a science background and understands diabetes and can hit the ground running with their diabetes medical device. The Regional Clinical Research Associate will be responsible for the overall clinical study conduct of clinical trials to ensure compliance with protocol(s) and Federal regulations, ICH and GCPs, and local requirements:
Travel: For post approval studies, the monitoring they're doing is all remote, right now travel not as intense, but when they ramp up for IDE travel could be heavy, it will ebb and flow, there will be times when they're on the road for a week at a time, then 2 weeks out.
Like Device over Pharma, but not required
They provide equipment, need them to start asap
Must have a minimum 4-year undergraduate degree in Natural Sciences or Engineering. Preferred is a graduate degree in same disciplines.
Must have a minimum of 2 years of applied experience in Clinical Sciences. Preferred is 5 years' experience in implantable medical device industry
Must be able to travel extensively (including international), many times on short notice
Well-versed in clinical aspects of GCP, FDA, AIMDD, ISO 14155 and other relevant experiences
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