Clinical Site Coordinator / Manager and GCP Workshop

The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. The purpose of this program is to assist Site Coordinators, Research Associates, and Study Nurses in improving their skills and their understanding of the responsibilities of the Clinical Research Site. This program is designed to address all of the functions of the research site related to the Good Clinical Practices as delineated by the U.S. Code of Federal Regulations and the guidelines supported by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines). The goal will be accomplished through lecture and practical application facilitated by clinical research professionals with a combined industry experience of more than 20 years. Information will be presented and discussed regarding administration of clinical trials according to FDA Regulations and International Council on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships