Core Competencies includes:● 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.