Brittany Williams
@brittanywilliams1
Clinical research regulatory coordinator ensuring compliance and efficient trial operations.
What I'm looking for
I am a detail-oriented Clinical Research Regulatory Coordinator with experience supporting oncology clinical trials and ensuring compliance with FDA, ICH-GCP, and IRB regulations. I prepare and manage regulatory submissions, maintain regulatory binders and Investigator Site Files, coordinate multi-site regulatory processes, and serve as a liaison among investigators, sponsors, CROs, and IRBs.
I have supported study start-up and continuing review activities, processed protocol-required specimens, managed staff training and credentialing, and used electronic regulatory systems such as OnCore, iRIS, and Advarra. I am pursuing an M.S. in Health Science with a concentration in Clinical Research Administration and hold certifications including CITI HSP, IATA, and GCP.
Experience
Work history, roles, and key accomplishments
Clinical Research Regulatory Specialist
Hematology Oncology Associates of Fredericksburg
Oct 2022 - Present (3 years 1 month)
Prepare, submit, and track IRB applications, IND/IDE reports, and regulatory binders to ensure GCP/ICH/FDA compliance; coordinated multi-site regulatory processes and supported study start-up and ongoing trial compliance.
Receptionist / Scheduler
Hematology Oncology Associates of Fredericksburg
Jan 2021 - Oct 2022 (1 year 9 months)
Managed front desk operations, patient check-in and scheduling, insurance verification, and maintained HIPAA-compliant patient records while providing administrative support to the clinical trials department.
Education
Degrees, certifications, and relevant coursework
Radford University
Master of Science, Health Science (Clinical Research Administration)
Pursuing a Master of Science in Health Science with a concentration in Clinical Research Administration, expected December 2025.
Radford University
Bachelor of Science, Psychology
Completed a Bachelor of Science in Psychology, graduating in May 2018.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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