Raisa Margolin
About Raisa Margolin
Raisa Margolin is a Clinical Protocol Navigator at the National Institutes of Health, where she has worked since 2021. She has extensive experience in clinical data management and regulatory compliance, having held various roles at NIH since 2012, and holds advanced degrees in Biomedical Engineering from Technion - Israel Institute of Technology and International Solomon University.
Work at National Institutes of Health
Raisa Margolin has held multiple positions at the National Institutes of Health (NIH) since 2012. She began her career at NIH as a Clinical Data Manager from 2012 to 2014. She then advanced to the role of Sr. Clinical Data Manager from 2014 to 2015. Following this, she worked as a Quality Control Specialist from 2015 to 2019. In 2019, she transitioned to the role of Protocol Data Analyst I, where she worked for nine months before becoming a Clinical Trials Administrator/Protocol Data Analyst II from 2020 to 2021. Currently, she serves as a Clinical Protocol Navigator, a position she has held since 2021.
Education and Expertise
Raisa Margolin has a strong educational background in Biomedical Engineering. She earned her Master of Science degree from Technion - Israel Institute of Technology, where she studied from 2000 to 2003. Prior to this, she obtained a Specialist Degree in Biomedical Engineering from International Solomon University in Kiev, Ukraine, from 1999 to 2000. Additionally, she completed her Bachelor of Arts in Biomedical Engineering at International Solomon University from 1994 to 1998. Her academic experience is complemented by her role as a Teaching Assistant and Research Assistant at Technion during her studies.
Clinical Protocol Management Responsibilities
In her current role as Clinical Protocol Navigator at NIH, Raisa Margolin coordinates with Principal Investigators and study team members to ensure compliance with various regulatory stipulations. She manages the completion of essential forms such as Resource Assessment Forms, Travel Reimbursement Forms, Ethics Clearance submissions, and Radiation Safety Committee submissions. Additionally, she maintains all regulatory trial documentation, ensuring that each trial has a complete and up-to-date Regulatory Binder, including documentation of investigator qualifications and safety reports.
Regulatory Compliance and Documentation
Raisa Margolin is responsible for creating and maintaining clinical protocol applications in the NIH Protocol Tracking and Management System (iRIS/PROTECT). She ensures that all applications comply with internal and external regulatory and monitoring requirements. Her role includes assisting research teams with the preparation and submission of patient recruitment materials, short form consents, and miscellaneous forms, as well as submitting documents for multisite studies. This expertise is crucial for maintaining the integrity and compliance of clinical trials.