Ashwini Ashwini Kokkera Jaganath
Clinical Research Trainee @Clinical Research Fastrack
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WORK HISTORY
Clinical Research Trainee @Clinical Research Fastrack
US
Hands-on intensive clinical research training, with a thorough understanding of clinical trial study protocol, clinical research duties, and study site operations.Key focus areas: ICH GCP E6 R(3)FDA Regulations 21CFR 11, 50, 54,56 and the Common Rule 45CFR46Data ManagementInformed Consent ProcessMedical terminologyClinical Trial Operations from feasibility through close-out.GDP following ALCOA-C principlesIdentification and reporting of AEs and SAEsQuality Assurance, Monitoring, and Query ResolutionComprehension and Execution of Clinical Trial ProtocolsMaintaining regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs, and other Investigator Site File (ISF) documents
EDUCATION
The New Cambridge High School
High School
UCSC Silicon Valley Extension
Beginners certification, Python programming
JAIN College
Certificate course in Bioinformatics, Bioinformatics
JAIN College
Master’s Degree, Biotechnology
JAIN College
Master of Biotechnology, Biotechnology
Software Technology Groups Ltd, Bangalore
Advance diploma in Bioinformatics
JAIN College
Bachelor’s Degree, Biotechnology
SKILLS
ABOUT ASHWINI ASHWINI KOKKERA JAGANATH
Focus and quality-driven Clinical Research professional with formal intensive training in understanding and hands-on experience in Clinical Research foundations. My passion for life science and the medicine industry motivated me to start my career as a biological and clinical data curator after completing my Master\'s in Biotechnology. I am motivated to fulfill my role in the clinical research industry, which emphasizes patient safety, rights, and welfare while bringing research drug molecules and treatment plans to fruition as solutions to patients\' recovery from diagnosed health issues.
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