Good Clinical Practice Basics/Role of the CRA with Kathi Durdon, Executive Director, CNY Biotech Accelerator
New York State SOCRA Chapter presents Good Clinical Practice and the Role of the CRA
Kathi Durdon, MA, CCRP, Executive Director, CNY Biotech Accelerator, Upstate Medical University
October 6, 2023, 10:00 – 11:50 a.m. EST
Presenter will review the quality standards for designing, conducting, recording, and reporting of clinical trials that involve the participation of human subjects – or GCP, Good Clinical Practice (per the International Conference on Harmonization). This includes a look at the history of “research” that provides the ethical backbone of GCP, importantly, how to protect human subjects whose participation allows us to advance safe and effective technologies, diagnostics, medicines, and treatment options. We will also discuss the key role of the Clinical Research Associate (and other titles) who are instrumental in conforming to GCP.
Kathi Durdon is Executive Director of the Central New York Biotech Accelerator (CNYBAC), SUNY Upstate Medical University’s 52,000+ square foot New York State Certified Business Incubator. Kathi manages incubator operations and support programs for small businesses working to commercialize a biotech-related product or service. Kathi creates and coordinates the monthly-held Concept to Commercialization Virtual Series as well as the Medical Device Innovation Challenge for early-stage innovators. Kathi continually works to expand networks within a collaborative innovation ecosystem to help streamline pathways for start-up companies. Kathi has a master’s degree in business policy and bachelor’s degrees in English and Anthropology. She is a past Board Member of SOCRA, the Business Incubator Association of New York State (BIANYS), and MedTech and is an Adjunct Assistant Professor at Upstate Medical University. Kathi presents for many student groups and professional organizations and volunteers for the Society of Clinical Research Associates (SOCRA) as a regulatory certification instructor and Annual Conference Device Track Chair. Prior to directing CNYBAC operations and programming, Kathi managed the Clinical Affairs team at Welch Allyn and directed the Clinical Trials Office at Upstate.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program will provide 1.8 hours of continuing education hours. When registering, note Certificate of Attendance Need (General or SOCRA).