Theresa Brooks

Clinical Research Professional @Clinical Research Fastrack

Completed a focused clinical research fastrack training program, building a robust skillset for contributing to well-conducted and compliant clinical trials. Achieved TransCelerate GCP certification and developed practical proficiency in key areas: ICH GCP E6 R (2), FDA regulations (21CFR 11, 50, 54, 56; 45CFR46), data management best practices, and the ethical implementation of the informed consent process. Gained insight into the end-to-end lifecycle of clinical trials, from initial feasibility assessments to successful close-out, with a focus on GDP (ALCOA-C) principles, accurate AE/SAE reporting, and the importance of quality assurance through monitoring and effective query resolution. Experienced in working with clinical trial protocols and the critical management of regulatory documentation within the Investigator Site File (ISF), including 1572s, DOAs, and training logs.