Remote Clinical Research Internship
• Clinical Trial Management:- Expertise in GCP compliance, TCPS2 and Clinical Trial Agreements (CTAs).- Developed and reviewed protocols, Case Report Forms (CRFs), and Informed Consent Forms (ICFs).- Prepared for site initiation visits with comprehensive checklists.• Data Management:- Proficient in data entry, statistical analysis, and documentation for Phase II/III studies on metabolicsyndrome and diabetes.- Managed Adverse Event (AE) and Serious Adverse Event (SAE) reporting.• Regulatory Compliance:- Prepared Institutional Review Board (IRB) applications and maintained documentation in line with ICHGCP E6, E2, and E8 guidelines.- Gained expertise in US, Canadian, and international clinical trial regulations through targeted training.• Patient Engagement:- Implemented effective patient recruitment and retention strategies.- Conducted clinical trial monitoring, ensuring adherence to protocols