Amanda Galster, MPH, CCRP, Associate Director of Clinical Trials, College of Pharmacy The University Of Arizona
Date and Time: July 22, 2024, 12:00 – 1:00 p.m. EST
Register in advance for this meeting:
https://upstate.zoom.us/meeting/register/tJIpf-ugqzItG9yG04bXEMZcRDz9O7D7Xwmm
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Summary: Ms. Galster will provide an overview of the ethical principles, federal regulations, and terminology for adverse event and safety monitoring in human subjects research. She will provide some practical ideas and tools for event monitoring and tracking, and will discuss the potential roles and responsibilities of clinical research professionals in this important work.
Objectives:
• Review the ethical principles, federal regulations, and terminology relevant to safety monitoring in human subjects research
• Review some practical solutions for adverse event monitoring and tracking
• Discuss the CRP’s possible roles and responsibilities in safety monitoring
Speaker Bio: Amanda Galster is a dedicated clinical research professional with 20 years of experience in site operations. She is currently the Associate Director of Clinical Trials at the University Of Arizona College Of Pharmacy where she and her team are developing an Investigator-Initiated Trial for Aging. Previously she worked for 17 years in pediatric clinical trials at the University Of Minnesota Department Of Pediatrics. Amanda has a Master’s in Public Health, and is currently enrolled in a Graduate Certificate program in Regulatory Science. She has been a SoCRA member since 2004, and certified since 2006. She is currently serving on the SoCRA Board of Directors, and was just elected to the Secretary position. Amanda has a passion for professional development for clinical research professionals and helping to educate the next generation of our workforce.
CE: 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).