Shelby Rae Gonzales
Remote Senior Clinical Research Associate @Thermo Fisher Scientific
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WORK HISTORY
Remote Senior Clinical Research Associate @Thermo Fisher Scientific
Wilmington, NC, US
Remote Senior Clinical Research Associate on 1 global, multicentre, randomized phase II and studies in RSV in older adult subjects. Serves as the primary site contact from study start up through close out and maintains regular site staff contacts, trainings, and query resolution support.Demonstrates an understanding of the disease from diagnosis through progression. Knowledgeable about standard of care and treatment approaches with strong understanding of the study as well as project-level knowledge of the disease area under investigation. Performs and coordinates tasks related to Pre-Study Assessment (PSA) and has oversight of site start-up activities during pre-activation phase to identify, escalate and mitigate any risks to site activation. Performs remote monitoring activities including continual review of clinical data, investigation of trends, and determination of appropriate action. Completes actions driving improved data currency to ensure protocol, regulatory, and SOP compliance and to guarantee subject safety, data integrity, and site compliance. Performs Remote Initiation Events, Remote Monitoring Events (with 100% or reduced SDV) and Remote Close-Out Events. Reviews electronic regulatory documents and electronic Investigator files and ensures subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Uses IVRS for IP set-up, accountability, and management. Participates in local interim analysis. Serves as the main point of contact for the Clinical Trial Manager (CTM), cascading info to the CRA team for assigned sites. Coordinates the monitoring and site management activities of the Associate CRA (ACRA), Onsite CRA (OCRA) and Clinical Trial Coordinator-Local (CTC-L). Triggers On-site Site Initiation Events/ On-site Monitoring Events/ On-site Close-out Events.
EDUCATION
University of Utah
Bachelor of Science - BS, Psychology
University of Utah
Bachelor of Science - BS, Cell/Cellular and Molecular Biology
Salt Lake Community College
Bioengineering and Biomedical Engineering
ABOUT SHELBY RAE GONZALES
I support sponsors in bringing clinical research studies from concept to clean data — with clarity, precision, and empathy for the humans involved at every stage. My work sits at the intersection of science, operations, and relationship-building.I collaborate with teams ranging from global research organizations to solo MD-scientists, ensuring that protocol goals align with real-world site capacity. Whether navigating study start-up, protocol amendments, or data reconciliation, I focus on efficient workflows and clear, honest communication to reduce friction and increase impact.Outside of clinical trials, I’m completing certification as a Functional Nutritional Therapy Practitioner (FNTP) and continuing hands-on training in Structural Integration. Through my private practice, Axis Health, I work with clients navigating issues like fibromyalgia, PCOS, and gut dysfunction — addressing systemic imbalances through a blend of structural and nutritional support.When I relocate to Gainesville in Fall 2025, I plan to continue this work alongside my research career. I\'m especially passionate about integrative approaches to chronic illness, and my long-term focus is building bridges between evidence-based research and embodied healing practices.
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