Job Title: Clinical Research Associate (CRA / Sr. CRA)
Location: Remote (Travel Throughout Midwest & East Coast)
Length of Assignment: 12+ Months
Pay Rate: $50/hr-$66/hr all-in rate (depending on experience)
Job Descripion:
Seeking experienced CRA and Sr. CRA consultants to support ongoing and upcoming cardiovascular medical device clinical studies. These individuals will serve as the primary owner for assigned sites and be responsible for end-to-end site management including site qualification, initiation, monitoring, closeout activities, regulatory compliance, source data verification, adverse event review, device accountability, and site relationship management.
Must Have:
* 5–7+ years of Medical Device CRA experience
* Independent site ownership experience
* Site qualification, initiation, monitoring, and closeout experience
* Ability to perform solo monitoring visits
* ICH-GCP and FDA regulatory knowledge
* Cardiovascular device and/or implantable device study experience
* Strong site relationship management skills
Nice to Have:
* Prior experience supporting cardiovascular clinical trials
* Investigator meeting support
* IRB/EC submission experience
* Site budget and contract experience
* Experience working directly with Medical Affairs, Regulatory Affairs, Quality, and Clinical Operations teams
* Master's Degree in a scientific discipline
Pay: $50.00 - $66.00 per hour
Application Question(s):
Work Location: Remote
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