Himanshu Patel
Clinical Research Assistant @DM Clinical Research
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WORK HISTORY
Clinical Research Assistant @DM Clinical Research
ICH GCP E6 R(2FDA Regulations 21CFR 11, 50, 54, 56 and the common rule 45CFR46Quality Assurance, Monitoring and Query ResolutionComprehension and Execution of Clinical Trial ProtocolsMaintaining a regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs and other Investigator Site File (ISF) documents,Data ManagementInformed Consent ProcessClinical Trial Operations from feasibilitythrough close-outGDP following ALCOA-C principlesIdentification and reporting of AEs and SAEs
EDUCATION
University of Perpetual Help System DALTA
Bachelor of Arts - BA, Clinical Psychology
University of Perpetual Help System DALTA
Doctor of Medicine - MD, Doctor of medicine
ABOUT HIMANSHU PATEL
As a dedicated and experienced physician with over 10 years in the medical field, I bring 6+ years of specialized expertise in clinical research. Holding a Doctor of Medicine (MD) degree, I have successfully contributed to numerous clinical trials in various capacities—including Principal Investigator, Clinical Research Associate, and Site Manager.My work is driven by a strong commitment to advancing medical science through evidence-based research and ethical clinical practices. I am a certified clinical research professional with hands-on experience in protocol development, regulatory compliance, patient safety, and site operations.I thrive in cross-functional teams and have a proven track record of leading studies that contribute meaningfully to both academic knowledge and patient care.Let’s connect if you\'re passionate about research, clinical development, or exploring collaborations in healthcare innovation.
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