Dhira Gupta

WORK HISTORY

EDUCATION

ABOUT DHIRA GUPTA

Experience with working in Clinical database and safety database.•Experience working with devices, vaccines•Experience working with devices, vaccines,etcExpereince working with eTMF.•Expertize in cardiovascular, respiratory and skin disorders.•Case processing, Triage, data entry, med DRA coding, narrative writing, case assessment, SAE reconciliation.•Determine eligibility and gather consent from study participants according to protocol. Assist in developing recruitment strategies.•Experience working in EDC and IRT system.• Maintaining the Regulatory documents.• Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents. •Complete study documents/case report forms.• Ensure compliance with research protocols, and review report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed.• Assemble study kits for study visits, monitor scheduling of procedures, coordinate documents, ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. Participate in monitor visits and regulatory audits.Experienced Ayurveda doctor and Certified Health Coach with a demonstrated history of working in the hospital & health care industry. Strong healthcare services professional with a Certificate focused in Clinical Trial Design and Management from San Francisco State University.