Olivia Yon
Fort Wayne,IN
Summary
A regulatory specialist with experience on community site and sponsor levels, who ensures compliance with regulations and guidelines in clinical research studies, prioritizing participant safety, promoting diversity and health equity. A detail-oriented team player with strong organizational skills and the ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
9
9
years of professional experience
Work History
Regulatory Coordinator
Inventa Center for Cancer Research
04.2017 - Current
- Manage 75+ investigator site files for Oncology and Hematology Clinical Trials, including start up, maintenance, and close out activities.
- Ensure the research site is in compliance with Good Clinical Practice and federal and local regulations.
- Act as site representative and submit documentation to Institutional Review Boards and other authorities on the regular basis.
- Organize and conduct protocol, SOP, and role specific training with research personnel and investigators.
- Meet regularly with clinical trial monitors, schedule research meetings for the Principal Investigator.
- Built a paperless system from the ground up that follows federal guidelines in an ongoing process to move from physical regulatory binders to electronic ISF.
- Act as site admin and superuser for the Florence eBinders Investigator Site File platform.
- Author and maintain Standard Operating Procedures (SOPs) for efficient operations of the research department.
Clinical and TMF Operations Associate
TG Therapeutics
09.2021 - 01.2022
- Perform regulatory start-up, maintenance, and close-out activities according to applicable regulations, SOPs, and guidelines.
- Serve as site regulatory contacts and provide regulatory-related study updates to CRAs or trial project teams.
- Prepare site regulatory documents and packets and perform essential document quality checks for completeness and accuracy.
- Monitor site level activities to ensure regulatory compliance and provide recommendations as needed.
- Oversee study, country, and site level TMF creation and maintenance and perform Trial Master File reviews for accuracy using tracking tools.
New Patient Scheduler
Fort Wayne Medical Oncology and Hematology
09.2015 - 04.2017
- Answer referral calls from outside health providers for new oncology and hematology patients.
- Proficient Navigation of OncoEMR and Centricity electronic medical records systems.
- Precisely enter patient information into EMR systems, including insurance and obtaining authorizations when required.
- Schedule and confirm patient appointments for doctor visits and chemotherapy treatments.
Education
Bachelor of Science - Health Sciences
Purdue Global
West Lafayette, IN07.2025
Certificate - Regulatory Affairs
Ivy Tech
Bloomington, IN05.2021
Skills
- Medical Terminology
- Regulatory Submissions
- Regulatory Policies
- Good Clinical Practice
- Customer Service
- Audits
- Electronic Investigator Site File
- Electronic Trial Master File
- Standard Operating Procedure Creation & Implementation
- Risk Management
- Microsoft Office Suite
- Florence eBinders
References
Available upon request.
Timeline
Clinical and TMF Operations Associate
TG Therapeutics
09.2021 - 01.2022
Regulatory Coordinator
Inventa Center for Cancer Research
04.2017 - Current
New Patient Scheduler
Fort Wayne Medical Oncology and Hematology
09.2015 - 04.2017
Bachelor of Science - Health Sciences
Purdue Global
Certificate - Regulatory Affairs
Ivy Tech
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