Yorel McKenzie
Clinical Research Associate
Raleigh,NC
Summary
Multi-disciplined, patient-centered molecular biologist with six years of Clinical Research experience, providing operational excellence in Global Clinical Research and Care.
Overview
6
6
years of professional experience
2
2
Languages
Work History
Clinical Research Associate II
IQVIA
04.2025 - Current
- Collaborates with sites, in conjunction with Sponsor team, to prepare sites for protocol amendments and new ICF versions. Which includes confirmation of site readiness, IMP, AxMP, equipment and supply inventory.
- Identifies and monitors trends indicating protocol deviations, Informed Consent Form non-compliance, level of adherence to AE/SAE reporting timelines, level of adherence to EDC entry timelines and investigator acknowledgement of safety reports.
- Conducts Site Qualification Visits, Site Initiation Visits, interim Remote and Onsite Visits, Close Out Visits, site handovers and conducts site staff training for high, medium and low risk sites.
Clinical Research Associate I
IQVIA
07.2022 - 03.2025
- Neurology and Ophthalmology clinical site monitoring (Roche Pharmaceutical). Temporary Lead CRA in unmasked/unblinded position.
- Conducts study start-up, site initiation, interim and close out visits.
- Study mentor to incoming Clinical Research Associates.
- Experience working with international team of monitors and Clinical Operation Leads (South America, Canada, France and UK) to ensure accurate and timely monitoring of protocol guidance.
Clinical Research Coordinator
Wake Research
04.2021 - 06.2022
- Reinforce patient retention, safety surveillance and closeout models for Pfizer and Medicago Covid-19 vaccine trials and GYN studies.
- Directly support Principle Investigator in maintaining Sponsor relationships, CRO transmission and overall success of studies at site level.
- Bolster and develop enrollment projects, compliance initiatives and subject retention. Drive site data management, quality control and efficient laboratory accessioning.
Clinical Research Assistant
University of North Carolina at Chapel Hill
01.2020 - 01.2021
- Campaign and recruitment management in university-wide, COVID-19 Convalescent Plasma Donation.
- Clinical assistance to participants, nurse coordinators and Principle Investigators in HIV Cure phase 0 to phase III clinical trials.
Education
Bachelor of Science - Cellular And Molecular Biology
Western Carolina University
Cullowhee, NCSkills
Clinical documentation
Quality control
Quality Assurance
IRB submissions
ICH-GCP
ALCOA
Biomedical Ethics
Clinical Ethics
Process improvement
Microsoft Office Suite
Cultural Intelligence and Diversity
Affiliations
- Women Inspired Network (WIN)
- Raleigh Chamber of Commerce
- Young Professional Network
Accomplishments
- Serves on the Research Triangle Park WIN Planning Committee and organizes outdoor, health socials that invite remote employees in RTP to connect in-person.
Timeline
Clinical Research Associate II
IQVIA
04.2025 - Current
Clinical Research Associate I
IQVIA
07.2022 - 03.2025
Clinical Research Coordinator
Wake Research
04.2021 - 06.2022
Clinical Research Assistant
University of North Carolina at Chapel Hill
01.2020 - 01.2021
Bachelor of Science - Cellular And Molecular Biology
Western Carolina University