Highly skilled Clinical Research Professional with a Doctorate in Physical Therapy and extensive experience in clinical research, patient care, and medical office operations. Expertise in coordinating clinical trials, managing regulatory documentation, and ensuring compliance with ICH GCP guidelines. Proven ability to work collaboratively with multidisciplinary teams to provide optimal patient care and support clinical trial success.
Clinical Research Fastrack, 01/24, Clinical Research Training covering Core Competencies including:, 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