The Intersection of Ethical Principles & Site Operations with Laura Holtz, Yale School of Medicine and Clinical Investigations (Virtual)
CNY Biotech Accelerator, Upstate Medical University presents The Intersection of Ethical Principles & Site Operations
February 28, 3:00 – 4:00 p.m. EST
Laura Holtz, MS, PMP, CCRP, Clinical Research Associate, Yale School of Medicine, Yale Center for Clinical Investigations (YCCI)
Register in advance for this meeting: (Zoom Link)
Over the years, I have attended numerous presentations about research ethics, including sessions that analyze warning letters or present real-life case studies of research misconduct. I have even participated on a research investigation committee for research misconduct. So often, we are looking at what happened, what should have happened, and what resulted in a finding. But often missing from all of the presentations, investigations, or exercises was a detailed analysis of the ethical implications. This presentation will describe the foundational ethical principles of clinical research and their historic context; apply ethical principles to site research operations tasks and responsibilities; and, develop strategies to ensure compliance with ethical principles at the research site. The intent of this presentation will ask learners to directly link ethical principles to the clinical research processes.
Laura is a Clinical Research Associate (Monitor) at Yale University Center for Clinical Investigations (YCCI). Previously, she was the project manager at Indiana University and Regenstrief Institute. She has extensive experience of site management for randomized control trials with participants with dementia and their caregivers residing in the community. She shares her expertise in research project management, regulations, informed consent, patient/caregiver interviewing, and data collection at numerous local and national conferences.
Laura established the SOCRA Indianapolis chapter and organizes education opportunities which provide pathways for staff to become Certified Clinical Research Professionals (CCRP). As a SOCRA Board Treasurer, she contributes to the organization’s strategic objections to provide research education, networking opportunities, and professional credentialing for the research community. She co-teaches the Site Management and GCP workshop for SOCRA. Laura has a Master’s degree in Communications from Purdue University.
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 hour of continuing education hours. When registering, note Certificate of Attendance Need (General or SOCRA).