Stephen Mubako

Clinical Research Professional @Clinical Research Fastrack

ICH GCP E6 R (2)•FDA Regulations 21CFR 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, DOA Training Logs and other Investigator Site File (ISF) documents.