Donna Sellers
Clinical Trial Specialist Ii @UBC
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WORK HISTORY
Clinical Trial Specialist Ii @UBC
Manages all aspects of site operations for clinical trials, including feasibility assessments, training, regulatory compliance, and site management. Executes confidentiality agreement, contract, and budget negotiation with sites. Conducts remote site monitoring visits, ensures patient safety, maintains IRB compliance, and tracks study milestones in CTMS. Prepares, reviews, and approves regulatory documents for site approval and drug release. Develops and maintains Trial Master Files in compliance with FDA, ICH/GCP, and local laws. Supports decentralized trials by developing operational processes, creating educational materials, and authoring project specific procedures for study coordinators and project teams.
EDUCATION
Claflin University
Bachelor of Science - BS
Claflin University
Master of Science - MS
Georgetown American University
Doctor of Medicine - MD
SKILLS
ABOUT DONNA SELLERS
Clinical Research Professional
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