Sheavonnie Wright, MSc.
Clinical Research Associate
Summary
Clinical Research Professional with 4+ years of experience driving operational excellence in complex oncology, transplant, and cell therapy trials at premier academic centers. Expertise spans the full trial lifecycle, from study start-up and regulatory submissions to data management, monitoring, and close-out, ensuring strict adherence to ICH-GCP, FDA regulations, and protocol.
A strategic operator recognized for bridging clinical operations with data integrity and compliance. Proven ability to manage multi-site communications, optimize workflows, and implement quality control measures that reduce errors by up to 60% and accelerate timelines. Serves as a key liaison between PIs, sponsors, and cross-functional teams to enhance patient recruitment, ensure audit-ready compliance, and facilitate timely database locks.
A published researcher and mentor, grounded in a Master's-level understanding of biomedical science. Combines deep technical proficiency in EDC (Medidata Rave, Inform) and CTMS (OnCore) with a commitment to advancing clinical research through meticulous attention to detail, process improvement, and leadership.
Portfolio
Resume Pack Portfolio (PDF)
CRC Work Tools Portfolio (PDF)
CRA Work Tools Portfolio (PDF)
Publications & Research Impact (PDF)
Certifications & Trainings (PDF)
Overview
4
4
years of professional experience
30
30
Percent faster query resolution than study average
19
19
Colleagues mentored in clinical research protocols
19
19
Staff members trained in GCP and protocol compliance
7
7
Contributions to translational and clinical publications
48
48
Hours average query resolution turnaround time
Work History
Clinical Research Associate/ Project Coordinator
Memorial Sloan Kettering Hospital Cancer Center
New York, USA
07.2024 - 12.2024
- Managed a portfolio of 14+ active oncology trials, serving as the primary operational lead and liaison between the Cancer Center, Radiology, and other departments to ensure seamless trial execution.
- Executed remote and on-site monitoring activities, performing comprehensive Source Data Verification (SDV) and case report form review for oncology and transplant trials, ensuring strict adherence to ICH-GCP and sponsor-specific SOPs.
- Accelerated study start-up timelines by 2 weeks for 3 new trials through simultaneous management of IRB submissions, feasibility assessments, and essential document collection.
- Initiated and led weekly data quality control reviews, identifying and rectifying discrepancies pre-monitoring, which decreased post-monitoring query volume by 30%.
- Served as the primary sponsor liaison for 5+ collaborating sites, facilitating communication on patient status, protocol compliance, and the timely resolution of complex data queries.
- Proactively resolved all data queries within a 48-hour average, facilitating timely database locks and ensuring data integrity for interim analyses.
- Acted as the primary translational link between clinical operations in the Cancer Center and diagnostic data from the Radiology Department, ensuring tumor response assessments (RECIST 1.1) were accurately captured and reported for pivotal trial endpoints.
- Championed the adoption of new workflow standards across the research team by developing and documenting SOPs for radiology coordination and biospecimen collection/transport.
Clinical Research Technician I
Weil Cornell Medicine
New York, USA
10.2022 - 07.2024
- Played a critical support role in clinical research operations for translational oncology studies, ensuring precise data collection and biospecimen processinglinked to imaging and response criteria.
- Engineered and implemented a novel biospecimen tracking system that reduced sample misidentification and processing errors by 60%, directly supporting data integrity for 5 peer-reviewed publications.
- Managed and maintained clinical trial datasets, performing data entry, validation, and reconciliation within EDC systems (Medidata Rave, REDCap, OnCore), achieving a 100% query resolution rate prior to data lock.
- Assisted in the preparation and submission of IRB protocols and amendments, improving regulatory turnaround time by 15%.
- Bridged the gap between the clinic and the lab by ensuring biospecimen collection was meticulously aligned with clinical patient data, directly supporting robust correlative science for 5+ translational research studies.
- Took independent initiative to audit and correct legacy data tracking methods, demonstrating a proactive approach to data integrity that extended beyond assigned responsibilities.
- Developed and led the practical training module for all new technicians on biospecimen processing, reducing the onboarding time for new team members by an estimated 25%.
Research Technician
Henderson Lab at Marshall University
Huntington, USA
01.2021 - 06.2022
- Conducted NIH-funded biomedical research, performing complex assays (cell culture, receptor binding) and analyzing large datasets using R Studio and GraphPad Prism.
- Contributed to 2 peer-reviewed publications in high-impact journals, strengthening skills in statistical analysis and scientific communication.
- Optimized lab protocols and troubleshooting workflows, strengthening the reproducibility and integrity of experimental results.
Skills
Clinical Trial Operations & Management
- Clinical Trial Coordination Study Start-Up & Close-Out Site Feasibility & Selection Patient Screening & Enrollment Informed Consent Process Visit Coordination Biospecimen Management
- Project Management Timeline & Milestone Tracking Risk Management & Mitigation Vendor & Budget Oversight Process Improvement & Workflow Optimization Cross-Functional Team Leadership
Regulatory, Compliance & Quality Assurance
- ICH-GCP Guidelines FDA 21 CFR Part 11 HIPAA Compliance IRB Submissions & Amendments Protocol Deviation Management Audit & Inspection Preparation CAPA Implementation
- Source Data Verification (SDV) Monitoring Visit Facilitation (SIV, IMV, COV) TMF/eTMF Management Investigator Site File (ISF) Maintenance SOP Development & Training
Data Management & Systems
- Electronic Data Capture (EDC): Medidata Rave, Oracle Inform, REDCap
- Clinical Trial Management Systems (CTMS): OnCore, Veeva Vault
- Electronic Medical Record (EMR): EPIC
- Data Integrity & Quality Control (QC) Query Resolution & Management Data Cleaning & Validation CRF/eCRF Review Database Lock Activities Adverse Event (AE/SAE) Reporting
Technical & Analytical Proficiencies
- Data Analysis & Visualization: Advanced Microsoft Excel (PivotTables, Macros), R Studio, GraphPad Prism, Tableau/Power BI Basics
- Laboratory Techniques: mRNA Extraction, RT-qPCR, Cell Culture, Fluorescent Microscopy, ImageJ Analysis
Leadership & Professional Strengths
- Stakeholder Liaison (Sponsor, CRO, PI, Site Teams) Staff Training & Mentorship Strategic Problem-Solving Interdepartmental Coordination Patient-Centered Mindset Detail-Oriented & Proactive
Certification
Clinical Research & Compliance
- CITI Program Certified: Good Clinical Practice (GCP) - ICH E6(R2)
- CITI Program Certified: Human Subjects Research (Biomedical)
- HIPAA & Privacy Certification
- IATA Dangerous Goods Shipping (2024)
- Eligible for SOCRA CCRP or ACRP-CRC upon professional tenure requirement
Safety & Emergency Response
- Certified in Adult & Pediatric Emergency Response (CPR/AED/First Aid)
- NYC FDNY C-14 Certificate of Fitness (Non-Production Chemical Laboratories)
Accomplishments
- Drove a 30% reduction in post-monitoring data queries by instituting a proactive, weekly quality control review process across all assigned trials.
- Maintained a flawless audit record with zero major findings during all sponsor and FDA inspections by ensuring 100% audit-ready documentation across CTMS, EDC, and eTMF systems.
- Accelerated clinical trial start-up timelines by 2 weeks for 3 new oncology studies through simultaneous management of IRB submissions and essential document collection.
- Engineered a novel biospecimen tracking system that reduced sample processing and misidentification errors by 60%, directly enhancing data reliability for 5+ peer-reviewed publications.
- Mentored and onboarded 19+ research staff on GCP and protocol procedures, leading to a measurable 40% improvement in team-wide protocol adherence.
- Achieved an average 48-hour query resolution turnaround, significantly outperforming study averages and contributing to timely database locks.
- Co-authored 7 peer-reviewed publications in high-impact journals, contributing data analysis and management that supported key translational and clinical findings.
Publications
- A Staphylococcus Dominant Nasal Microbiota in Hemodialysis Patients. Kidney Medicine. 2025. DOI:10.1016
- Impact of Ultrasound-Guided Percutaneous Core Needle Biopsy on Biomarkers of Human Kidney Allograft Status. Transplantation. 2024. PMID: 40048628
- The Yin and Yang of Acute Rejection in Kidney Allografts. Journal of the American Society of Nephrology. 2024. DOI:10.168
- Chemical Flavorants in Vaping Products Alter Neurobiology in a Sex-Dependent Manner to Promote Vaping-Related Behaviors. Journal of Neuroscience. 2023. PMID: 36690450
- A Systematic Investigation on the Impact of Invasive Kidney Allograft Biopsy on Urinary Cell mRNA Profiles. Journal of the American Society of Nephrology. 2023. DOI:10.1681
- Molecular Similarity Between Chronic Active Antibody-Mediated Rejection (CA-ABMR) and Acute T Cell-Mediated Rejection (TCMR) of Human Kidney Allografts. Journal of the American Society of Nephrology. 2023. DOI:10.1681
- Morphine Exposure Reduces Nicotine-Induced Upregulation of Nicotinic Receptors. Nicotine & Tobacco Research. 2022. PMID: 34999827
Education
MSc - Biomedical Research with Medical Science and Research Emphasis
Marshall University Joan C. Edwards School of Medicine
Huntington, WVBA - Chemistry with a Concentration in Biochemistry
The City University of New York: Herbert H. Lehman College
New York, NYQuote
I advance clinical research by bridging meticulous data integrity with a deep understanding of translational science, ensuring that every protocol and data point translates into real-world patient impact.
Sheavonnie Wright, MSc
Languages
English
Native language
Spanish
Intermediate (B1)
B1
Software
EDC & Data Systems: Medidata Rave, Oracle Inform, REDCap, Clindex CTMS: OnCore, Veeva Vault EMR: Epic
Data Analysis & Visualization: Advanced Excel (PivotTables, Macros), R Studio, GraphPad Prism, SPSS, Tableau, Power BI
Project Management & Collaboration: Smartsheet, Microsoft Teams, SharePoint, Slack, DocuSign
Interests
Clinical Trial Innovation & Operational Excellence
Translational Research & Biomarker Discovery
Patient Advocacy & Health Equity
Scientific Communication & Medical Education
Mentorship & Professional Development
Community Health Outreach
Community Engagement & Education
Clinical Sciences Tutor (Remote/Part-Time)
Mildred Elley College | New York, NY | 2025 - Present
- Provide individualized and group tutoring in Anatomy & Physiology and Medical Terminology for clinical sciences students.
- Utilize data-driven strategies to track student progress and develop targeted academic intervention plans.
- Reinforce core scientific principles essential for success in clinical and research-focused careers.
Middle School In-House Math Tutor (7th Grade) – Contract
SmartStart Education | January 2025 – June 2025
- Designed and implemented tailored lesson plans for small-group tutoring, resulting in an average 40% improvement in student exam scores within one semester.
- Fostered a supportive learning environment that boosted student confidence and foundational problem-solving skills, applicable to STEM education and beyond.
- Collaborated with lead teachers to align tutoring strategies with curriculum goals, ensuring consistent and effective student support.
Urban Male Leadership Program (UMLP) – Member & Honoree
CUNY Lehman College | 2016 – 2020
- Selected for a competitive leadership program dedicated to empowering underrepresented students in higher education.
- Recognized with the Urban Female Leader of the Year Award (2020) for demonstrated leadership excellence and commitment to community engagement.