Carrie R. Smith
Senior Director, Clinical Operations @Bicara Therapeutics
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WORK HISTORY
Senior Director, Clinical Operations @Bicara Therapeutics
Boston, MA, US
EDUCATION
The George Washington University School of Medicine and Health Sciences
BS, Health Science
ABOUT CARRIE R. SMITH
Highly motivated, results driven, teamwork oriented individual with 25+ years of clinical research experience in pharmaceutical and medical device clinical trials at the Sponsor and CRO level. Experience includes oversight and management of all clinical trial activities to include day to day management of clinical trial study teams within department and functional leads from other teams, overall study project management, interface with the FDA, site identification and selection, monitoring, contract and budget negotiation, management of CROs, contract CRAs, and other vendors, management of patient recruitment and retention programs, development and implementation of patient advocacy program, development of study documents (protocols, CRFs, source docs, ICFs), oversight and/or maintenance of trial master files (eTMF), remote data entry and verification, writing SOPs, and IRB/FDA submissions. Therapeutic experience includes Oncology, Biologics, Rare Disease, Urology, Cardiology, Gastroenterology, Dermatology, Orthopedics, and Neurology.
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