Ashley Oleary
Dallas,TX
Summary
Clinical Research Professional with over five years of experience supporting Phase II–IV clinical trials across academic, government, and private research settings. Experienced in clinical data management, electronic data capture (EDC), CRF review, query resolution, regulatory compliance, and database quality assurance. Proficient in Medidata Rave, Oracle, REDCap, Medrio, Clinical One, and Veeva. Recognized for maintaining data integrity, ensuring protocol compliance, and collaborating with sponsors, CROs, and investigators to deliver accurate, audit-ready clinical trial data. Seeking to transition into a clinical data role where strong analytical skills, attention to detail, and clinical research expertise can contribute to high-quality study outcomes.
Overview
8
8
years of professional experience
Work History
Senior Clinical Research Coordinator
Dallas VA Research Corporation
06.2026 - Current
- Managed clinical trial data throughout the study lifecycle while ensuring compliance with protocols, GCP, FDA, and IRB requirements.
- Performed accurate data entry into electronic data capture (EDC) systems and maintained high-quality study documentation.
- Reviewed source documents and case report forms (CRFs) for completeness, accuracy, and protocol compliance.
- Investigated and resolved data queries in collaboration with sponsors, monitors, and investigators.
- Conducted quality control reviews to ensure database accuracy prior to monitoring visits and audits.
- Maintained regulatory documentation and essential study records to support inspection readiness.
- Coordinated laboratory and imaging data collection, ensuring accurate documentation and timely reporting.
- Supported sponsor monitoring visits by preparing audit-ready documentation and resolving outstanding data discrepancies.
- Coordinated safety reporting, adverse event documentation, and regulatory compliance
- Managed subject scheduling, enrollment tracking, and retention
- Supported sponsor and CRO monitoring visits and audits
- Performed clinical procedures per GCP, SOPs, and regulations
- Trained new staff and collaborated with investigators
- Ensured accurate data entry and timely query resolution
- Cardiology, Hematology, Nuclear Medicine, and Oncology Clinical Trials
Senior Clinical Research Coordinator (Contract)
Joule at Cedar Health Research
12.2025 - 06.2026
- Lead coordination of multiple Phase II–IV clinical trials ensuring quality assurance, good clinical practice, and data integrity
- Serve as primary liaison between investigators, sponsors, CROs, and monitors
- Manage clinical databases and source documentation
- Oversee subject recruitment, screening, consenting, enrollment, and visit coordination
- Ensure accurate and timely data entry, CRF completion, and query resolution
- Coordinate investigational product accountability and laboratory specimen handling
- Support monitoring visits and audits; implement corrective and preventive actions (CAPAs)
- Train and mentor coordinators and site staff
- Weight loss and endocrinology studies
Clinical Research Coordinator II
University of Texas Southwestern Medical Center
03.2025 - 08.2025
- Prepared, reviewed, and maintained study documentation, including consent forms, enrollment notes, and regulatory submissions.
- Managed laboratory specimen collection and chain-of-custody documentation while maintaining data integrity, reconciling laboratory results, and resolving data discrepancies with sponsors and central laboratories.
- Coordinated and completed participant visits in accordance with protocol specifications and ICH-GCP while ensuring accurate source documentation, timely data collection, and complete case report form (CRF/eCRF) documentation
- Verified participant eligibility by reviewing inclusion/exclusion criteria, ensuring accurate documentation and protocol compliance prior to enrollment.
- Nephrology Clinical Research
- Short Term Role
Clinical Research Coordinator
Pillar Clinical Research
11.2021 - 12.2022
- Maintained and reviewed regulatory binders and essential study documents to ensure accuracy, version control, and audit readiness.
- Managed subject visit scheduling, enrollment tracking, and sponsor communications while ensuring accurate study documentation and timely data collection.
- Supported sponsor monitoring visits by ensuring source documentation was complete, accurate, and audit ready.
- Mental Health Clinical Research (Substance Use Disorders, Schizophrenia)
Undergraduate Research Assistant
Anxiety & Health Research Lab
06.2018 - 06.2019
- Screened and recruited participants and scheduled study visits
- Conducted psychological assessments and maintained study documentation
Education
Bachelor of Science - Psychology
University of Houston
Houston, TX08-2019
Skills
- Clinical Data Management, Electronic Data Capture (EDC), CRF/eCRF Completion, Data Validation, Query Resolution, Data Cleaning, Source Data Verification, Database Quality Control, Clinical Trial Documentation, ICH-GCP, FDA Regulations, Audit Readiness, Risk-Based Monitoring, and Regulatory Compliance
- Medidata Rave, Oracle, Medrio, REDCap, Clinical One, Veeva, Clinical Research IO, DrugDev Spark, 4GClinical, PPD Preclarus Lab, Microsoft Excel, and Microsoft Word
Timeline
Senior Clinical Research Coordinator
Dallas VA Research Corporation
06.2026 - Current
Senior Clinical Research Coordinator (Contract)
Joule at Cedar Health Research
12.2025 - 06.2026
Clinical Research Coordinator II
University of Texas Southwestern Medical Center
03.2025 - 08.2025
Clinical Research Coordinator
Pillar Clinical Research
11.2021 - 12.2022
Undergraduate Research Assistant
Anxiety & Health Research Lab
06.2018 - 06.2019
Bachelor of Science - Psychology
University of Houston