Brandy M. Lee
Brandy is an accomplished clinical research professional with 7 years of experience in medical device trials and 15 years in the cardiovascular clinical setting. She started her clinical research career at Cardiopulmonary Science and Research Institute (CRSTI), specializing in Class III cardiovascular medical device studies. Brandy began as a Clinical Trial Assistant, quickly moving to Lead Clinical Research Coordinator with CRSTI. In 2016, Brandy began working as a Clinical Research Associate II at a Sponsor company, where she oversaw the daily operations of a Class III Pivotal prosthetic heart valve study. In this role, her duties included ensuring regulatory and protocol compliance, conducting on-site and centralized monitoring visits, as well as managing CRAs with a contracted CRO for report monitoring, protocol training, and as an escalation resource. Brandy came to Covance (then Chiltern) in 2017 as a Clinical Research Associate II. During her time at Covance, Brandy has progressed from CRA II, Senior CRA, a hybrid role of Sr. CRA / Associate Line Manger and now serves as Manager, Clinical Operations. Brandy has also managed clinical affairs for a biotech start-up company where she was responsible for developing study protocol, management plans, and subject recruitment plans for a Class II artificial intelligence diagnostic device.
Trial and Therapeutic Experience
Brandy has been participating in and monitoring clinical trials with FDA Class II and Class III medical devices over the past 7 years. She has experience with implantable cardiovascular devices for transthoracic aortic valve replacement, atrial fibrillation, coronary artery disease, in-stent restenosis, stroke, and peripheral artery disease. These trials have encompassed feasibility, pivotal and registry studies. Her experience also includes Neurology studies focusing on embolic protection devices. Her expertise also includes managing clinical trials for compliance with ICH GCP Guidelines and FDA regulations, and building strong, productive relationships with sponsors, investigators and coordinators.
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