Clement Tega Okiti

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 regulatory binder, housing essential documents including but not limited to 1572, DOA-Training Logs and other Investigator Site File (ISF) documents