Chichi N

Clinical Research Professional @Clinical Research Fastrack

ICH GCP E6 R (2)-FDA Regulations 21 CFR 11, 50, 54, 56 and the Common Rule 45CFR46 -Data Management -Informed Consent Process -Clinical Trial Operations from feasibility through close-out -GDP following ALCOA-C principles -Identification and reporting of AEs and SAEs -Quality Assurance, Monitoring and Query Resolution -Comprehension and Execution of Clinical Trial Protocols -Maintaining a regulatory binder, housing essential documents including but not limited to 1572, Source Documents, DOA, Training Logs and other Investigator Site File (ISF) documents -Financial Disclosures -Site Visit Logs -Standard Operating Procedures and Correspondences -Protecting Patient Rights and Safety