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Brittany Williams

@brittanywilliams1

Clinical research regulatory coordinator ensuring compliance and efficient trial operations.

United States
Message

What I'm looking for

I seek regulatory-focused roles in clinical research where I can apply GCP/FDA expertise, support multi-site oncology trials, and grow into increased responsibility within collaborative, compliance-driven teams.

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

HF
Current

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.

Education

Degrees, certifications, and relevant coursework

Radford University logoRU

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 logoRU

Radford University

Bachelor of Science, Psychology

Completed a Bachelor of Science in Psychology, graduating in May 2018.

Tech stack

Software and tools used professionally

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Brittany Williams - Clinical Research Regulatory Specialist - Hematology Oncology Associates of Fredericksburg | Himalayas