Jessica Davidson .O.
Irving,TX
Summary
Dynamic Clinical Research Professional with over 5 years of progressive experience leading and coordinating clinical trials across diverse therapeutic areas, including oncology, ophthalmology, cardiology, hepatology, and infectious diseases. Expertise in managing the full lifecycle of clinical projects while optimizing site performance and ensuring strict adherence to regulatory compliance with FDA, ICH-GCP, and ALCOA-C standards. Skilled in cross-functional leadership, risk mitigation, stakeholder engagement, and data-driven decision-making to consistently deliver trials on time and within scope. Recognized for a commitment to operational excellence, patient safety, and achieving high-quality data outcomes.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Assistant Clinical Research Site Manager
DFW Elite Trials
Dallas-Fort Worth, TX
11.2025 - Current
- Directed end-to-end clinical trial operations, ensuring strict adherence to GCP, FDA regulations, and study protocols across multiple concurrent studies
- Led cross-functional teams (CRC, regulatory, lab, and recruitment staff) to improve study execution and protocol compliance
- Accelerated study start-up timelines by managing regulatory submissions, IRB approvals, and site initiation activities
- Oversaw EDC data management, ensuring real-time data entry, query resolution, and ≥98% data accuracy
- Implemented patient recruitment strategies that increased enrollment rates and reduced screen failure ratios
- Partnered with sponsors and CROs to proactively resolve study risks, maintain timelines, and improve delivery metrics
- Managed audit and inspection readiness, resulting in successful sponsor and regulatory audits with zero critical findings
- Optimized operational workflows, improving team efficiency and reducing protocol deviations
Senior Clinical Research Coordinator (Oncology)
UT Southwestern Medical Center
Dallas, TX
09.2022 - 08.2025
- Managed complex oncology clinical trials, coordinating daily operations and ensuring compliance with protocols and regulatory requirements
- Led patient-facing activities, including recruitment, screening, and informed consent for therapeutic and observational studies
- Coordinated multidisciplinary teams (physicians, pharmacy, lab, imaging) to ensure timely execution of protocol-required procedures
- Tracked and reported AEs/SAEs, ensuring timely safety reporting and regulatory compliance
- Improved patient retention and engagement through proactive communication and education strategies
- Trained and mentored research staff, enhancing team performance and protocol adherence
- Ensured accurate specimen handling and shipment in compliance with IATA guidelines
- Acted as key liaison between investigators, sponsors, and patients to ensure seamless study execution
Clinical Research Coordinator
Zenos Clinical Research
Dallas, TX
02.2019 - 08.2022
- Supported management of multiple clinical trials across diverse therapeutic areas, ensuring adherence to timelines and protocols
- Executed patient recruitment strategies, improving enrollment and maintaining study pipelines
- Maintained regulatory documentation and study records, ensuring audit readiness and compliance
- Performed high-quality data entry and validation, ensuring accuracy and completeness in EDC systems
- Collaborated with investigators and sponsors to support successful study delivery
- Participated in site initiation visits and investigator meetings, contributing to study planning and execution
Clinical Research Specialist
Queen Mary’s Hospital
London, UK
01.2018 - 01.2019
- Conducted data analysis and literature reviews to support clinical research design and decision-making
- Developed research reports, presentations, and manuscripts for academic and clinical audiences
- Contributed to protocol development and data collection processes
- Trained junior researchers, strengthening team research capabilities
- Ensured compliance with clinical research standards and regulatory requirements
Clinical Research Specialist
Medicines and Healthcare Regulatory Agency
London, UK
01.2016 - 01.2018
- Evaluated adverse event reports to ensure regulatory compliance and patient safety
- Performed signal detection and risk assessment, supporting pharmacovigilance activities
- Maintained clinical databases, ensuring data integrity and accuracy
- Collaborated with regulatory bodies, ensuring timely submission of safety data
Education
Master of Global Health & Clinical Research -
University of Aberdeen
UKBachelor of Pharmacy - undefined
University of Benin
Diploma in Clinical Research - undefined
Clinical Research FastTrack Academy
Skills
- Clinical Trial Project Management (Phase I–IV)
- Study Start-Up & Site Activation
- Documentation and reporting
- Site management
- Risk Management & Issue Resolution
- Regulatory Compliance (FDA, ICH-GCP, HIPAA)
- Patient Recruitment & Retention Strategy
- EDC Systems & Data Integrity Oversight
- AE/SAE Reporting & Safety Monitoring
- Cross-Functional Team Leadership
- Stakeholder Communication & Reporting
Accomplishments
- Successfully led multiple clinical trials from start-up to close-out, meeting or exceeding enrollment and timeline targets
- Improved data quality and reduced query turnaround time through proactive EDC oversight
- Enhanced audit readiness, achieving zero critical findings during inspections
- Increased patient recruitment and retention rates through strategic engagement initiatives
Certification
- ICH-GCP / HIPAA
- IATA (Specimen Handling)
- CPR/AED (American Heart Association)
Timeline
Assistant Clinical Research Site Manager
DFW Elite Trials
11.2025 - Current
Senior Clinical Research Coordinator (Oncology)
UT Southwestern Medical Center
09.2022 - 08.2025
Clinical Research Coordinator
Zenos Clinical Research
02.2019 - 08.2022
Clinical Research Specialist
Queen Mary’s Hospital
01.2018 - 01.2019
Clinical Research Specialist
Medicines and Healthcare Regulatory Agency
01.2016 - 01.2018
Bachelor of Pharmacy - undefined
University of Benin
Diploma in Clinical Research - undefined
Clinical Research FastTrack Academy
Master of Global Health & Clinical Research -
University of Aberdeen
KEYWORDS FOR ATS OPTIMIZATION
- Clinical Project Management
- Clinical Trials
- CRO Management
- Study Start-Up
- Risk Management
- FDA Compliance
- ICH-GCP
- Trial Master File (TMF)
- Monitoring
- Vendor Management
- Clinical Operations
- Patient Safety
- Data Management
- Oncology Trials
- Regulatory Submissions
- Site Management
- Quality Assurance
- Audit Readiness
- Protocol Compliance