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Isabel Rivera

@isabelrivera

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Senior Clinical Research Coordinator at Wake Research overseeing women’s health and immunology trials.

United States

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At Wake Research, I coordinate and oversee site operations for women’s health and immunology clinical trials, supporting compliance with ICH-GCP, FDA, and sponsor requirements. I review study data, resolve EDC queries, and maintain essential regulatory documents.

At Rady Children’s Hospital, I coordinated seven pediatric allergy and immunology trials, from start-up through close-out. At UCSD Antiviral Research Center, I coordinated Moderna and AstraZeneca COVID-19 vaccine trials and developed source documentation templates and SOPs to improve data consistency.

Experience

Work history, roles, and key accomplishments

Current

Senior Clinical Research Coordinator

Current

Wake Research

Oct 2022 - Present (4 years)

Lead CRC for multiple women's health and immunology clinical trials, coordinating daily site operations and ensuring compliance with ICH-GCP, FDA, and sponsor requirements. Serves as primary site contact for sponsors, monitors, and vendors, and supports trial start-up activities.

Clinical Trials ICH GCP FDA Regulations Regulatory Compliance EDC Source Documents IRB Submission Site management Recruitment Training

Clinical Research Coordinator

Rady Children's Hospital

Jan 2022 - Sep 2022 (8 months)

Lead CRC for seven pediatric allergy/immunology clinical trials, managing study start-up through close-out activities in compliance with sponsor protocols, IRB standards, and GCP guidelines. Prepared and submitted IRB applications and maintained audit-ready regulatory binders.

Clinical Trials ICH GCP IRB Submission Regulatory Binder Source to CRF Verification Query Resolution Protocol Deviations Specimen Processing Vendor Management

Clinical Research Coordinator

UCSD Antiviral Research Center

Oct 2020 - Sep 2021 (11 months)

Oversaw participant caseloads for Moderna and AstraZeneca COVID-19 vaccine trials, managing end-to-end study coordination including subject screening, informed consent, visit scheduling, data entry, and follow-up. Developed source documentation templates and SOPs to improve data consistency.