Summary
Portfolio
Overview
Work History
Skills
Certification
Accomplishments
Publications
Education
Quote
Languages
Software
Interests
Community Engagement & Education
Websites
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Sheavonnie Wright, MSc.

Sheavonnie Wright, MSc.

Clinical Research Associate

Summary

Clinical Research Professional with 4+ years of experience supporting oncology, transplant, and cell therapy trials across interventional and observational settings. Skilled in trial operations, regulatory compliance, and patient-focused coordination, with a proven record of keeping studies audit-ready and on track from start-up through closeout.

Operational & Clinical Bridge — experienced in assisting monitoring visits, tracking patient progression, resolving protocol deviations, and optimizing workflows to improve protocol adherence. Recognized for strong collaboration with PIs, sponsors, and site teams, resulting in measurable gains in trial efficiency and compliance.

Published Researcher & Award-Winning Leader — contributor to high-impact journals and recognized for mentoring and community engagement. Grounded in GCP and regulatory frameworks, with specialized expertise in biospecimen handling, data accuracy, and sponsor/stakeholder communication to safeguard patient outcomes.

Portfolio

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Resume Pack (PDF)
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CRC Work Tools Portfolio (PDF)
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CRA Work Tools Portfolio (PDF)
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Publications & Research Impact (PDF)
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Certifications & Trainings (PDF)

Overview

8
8
years of professional experience
20
20

CITI Program Certifications Completed

50
50

Clinical Trials Supported across various therapeutic areas

7
7

High-Impact Publication Contributions

19
19

Staff mentored in GCP, SOP, and protocol compliance

2
2

NIH-funded research internships completed

Work History

Math Tutor (Contract)

Smartstart Education
New York, NY
01.2025 - 06.2025
  • Designed tailored lesson plans in algebra for 7th-grade students, improving exam scores by an average of 40% within one semester while demonstrating attention to detail and workflow management applicable to clinical research operations.
  • Simplified complex mathematical concepts into practical learning strategies, fostering student confidence, structured problem-solving, and skills transferable to project coordination and team guidance.
  • Built supportive relationships with students, emphasizing discipline, organization, and mentorship—highlighting abilities in leadership, communication, and operational oversight.
  • Completed 20 online courses in tutoring, mentorship, and student engagement, strengthening communication, organization, and team leadership skills applicable to clinical research operations.

Clinical Research Associate

Memorial Sloan Kettering Hospital Cancer Center
New York, USA
07.2024 - 12.2024
  • Oversaw over 15 concurrent oncology trials, coordinating patient scheduling, protocol compliance, and data capture to achieve sponsor milestones and uphold patient safety.
  • Designed Excel-based scheduling tools that improved visit accuracy by 40%, supporting a zero-finding FDA audit and enhancing site efficiency.
  • Acted as primary liaison with sponsors, PIs, IRBs, and FDA, resolving 50+ protocol deviations through timely documentation, IRB submissions, and patient re-consents.
  • Prepared and maintained regulatory documentation, ensuring 100% audit-ready TMFs, eReg binders, and source files across multiple studies.
  • Led weekly team meetings and trained new CRCs on ICH-GCP and institutional SOPs, driving a 30% increase in adherence and a 98% on-time completion rate for assessments.
  • Managed biospecimen logistics and chain-of-custody, ensuring accurate labeling, secure transfers, and protocol-aligned processing for downstream analysis.
  • Supported sponsor monitoring visits and interim analyses, reconciling data queries and maintaining inspection readiness.

Clinical Research Technician I

Weil Cornell Medicine
New York, USA
10.2022 - 07.2024
  • Coordinated patient visits and assessments within protocol windows, ensuring compliance with FDA and sponsor standards across 5 active transplant trials.
  • Managed biospecimen collection and lab logistics, maintaining chain-of-custody and precise clinic-to-lab documentation.
  • Performed molecular lab techniques (mRNA extraction, RT-qPCR), generating reproducible gene expression data that informed study endpoints.
  • Collaborated with surgeons, nephrologists, and lab staff to troubleshoot procedural issues and uphold GCP standards.
  • Co-authored publications in journals such as The American Journal of Transplantation, advancing understanding of kidney transplant outcomes.

Research Technician

Henderson Lab at Marshall University
Huntington, USA
01.2021 - 06.2022
  • Led independent projects on N2A cell cultures, transient transfections, and fluorescent microscopy, producing high-quality data for NIH-backed research.
  • Applied ImageJ and quantitative analysis to assess effects of vape flavorants on nAChR signaling pathways.
  • Optimized lab protocols and troubleshooting workflows, strengthening reproducibility and integrity of experimental results.
  • Contributed to 2 peer-reviewed publications in The Journal of Neuroscience and Nicotine & Tobacco Research.

Internship Student

National Institutes of Health, NHLBI
Bethesda, MD
06.2017 - 08.2019
  • Completed two competitive internships supporting translational research on vascular biology and extracellular matrix genetics.
  • Assisted with experimental design, sample processing, and data analysis, honing core research methodology and scientific writing skills.
  • Engaged in multidisciplinary meetings and collaborative projects, developing a foundation in cross-functional scientific communication.

Skills

Technical & Analytical Skills

  • Proficient in CTMS, EDC, EMR, REDCap, Veeva Vault, and TMF systems for accurate data capture, query resolution, and streamlined reporting
  • Advanced lab and data analysis skills including ImageJ, GraphPad Prism, RStudio, RT-qPCR, and fluorescent microscopy
  • Strong knowledge of GCP, ICH, FDA, IND/IDE, and HIPAA regulations ensuring compliance and inspection readiness
  • Experienced in AE/SAE reporting, source data verification (SDV), protocol deviation documentation, and informed consent tracking
  • Prepared for FDA audits, sponsor monitoring visits, and multi-site trial oversight, maintaining audit-ready documentation

Operational & Project Management Skills

  • Led multi-site and multi-phase study operations, including trial start-up, monitoring, close-out, and workflow optimization
  • Skilled in project planning, milestone tracking, budget monitoring, and risk identification/mitigation
  • Coordinated SIVs, SQVs, IRB submissions/amendments, and regulatory binder maintenance
  • Developed Excel/Smartsheet-based tracking tools to streamline patient scheduling, study visits, and operational reporting
  • Facilitated cross-functional collaboration across clinical, lab, sponsor, and investigator teams for seamless trial execution

Leadership & Stakeholder Engagement

  • Trained, mentored, and onboarded new CRCs, enhancing protocol adherence and operational efficiency
  • Strong communicator liaising between PIs, sponsors, site teams, monitors, and regulatory bodies
  • Experienced in team leadership, conflict resolution, and driving high-performing, patient-focused teams
  • Adaptable and detail-oriented, managing multiple studies, shifting priorities, and hybrid/remote operations

Soft Skills & Professional Strengths

  • Strategic problem solver with a proactive approach to operational challenges and study bottlenecks
  • Patient-centered mindset with strong organizational and time-management abilities
  • Effective in documentation, reporting, and ensuring compliance while maintaining study integrity
  • Skilled at translating complex research or project information into actionable outcomes

Certification

CITI Program Certifications (Completed 2022–2024):
• Good Clinical Practice (GCP) – ICH E6(R2)
• Human Subjects Protection (HSP) – Biomedical Research
• Conflicts of Interest (COI)
• Biomedical Research Investigators & Key Personnel
• Dangerous Goods Shipping (IATA/ICAO)
• HIPAA Privacy & Security Training

Emergency & Safety Certifications:
• CEPR: Certified in Adult & Pediatric Emergency Response (CPR/AED)
• C-14 Certificate of Fitness – Non-Production Chemical Laboratories (NYC FDNY, active since 2022)

Additional Certifications/Training:
• BLS Healthcare Provider – Scheduled Dec 2025
• Eligible for CCRC/CCRP certification within 1 year of hire (ACRP/SOCRA)
• Formal CRA training covering responsibilities, regulatory compliance, and trial oversight
• 15+ online modules completed through Smartstart Education, enhancing teaching, mentorship, and project coordination skills

Accomplishments

  • Spearheaded protocol adherence initiatives, boosting compliance by 30% through collaborative leadership and streamlined operational workflows.
  • Supported FDA inspections with zero findings by maintaining meticulous data accuracy and audit-ready documentation across CTMS, REDCap, EMR, and sponsor platforms.
  • Managed multisite trial operations, including patient enrollment, visit scheduling, biospecimen tracking, and regulatory documentation, ensuring timely milestone achievement and protocol adherence.
  • Developed Excel- and Smartsheet-based tools that improved scheduling accuracy by 40%, optimized workflow efficiency, and enhanced cross-functional team coordination.
  • Trained and mentored new CRCs and team members, improving protocol adherence by 40% and maintaining a 98% on-time completion rate for study assessments.
  • Collaborated closely with PIs, sponsors, monitors, and cross-functional teams to resolve over 50 protocol deviations, ensuring patient safety and data integrity.
  • Co-authored 7 peer-reviewed publications and research letters, including:
    Transplantation (2024) – Kidney Allograft Biomarkers
    Journal of Neuroscience (2023, 2021) – Vape flavorants & nAChR signaling
    Nicotine & Tobacco Research (2022, 2021) – Nicotine receptor studies & neurotoxicity
    Kidney Medicine (2024) – Research letter on microbiota in hemodialysis patients
    American Journal of Transplantation (2022) – Translational kidney transplant research
  • Exceeded enrollment targets and accelerated visit timelines while maintaining rigorous ethical standards and patient-centered care.
  • Applied advanced technical skills (ImageJ, GraphPad Prism, RStudio) to analyze complex datasets, translating laboratory and clinical data into actionable insights for study endpoints.

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, WV

BA - Chemistry with a Concentration in Biochemistry

The City University of New York: Herbert H. Lehman College
New York, NY

Quote

Fueled by curiosity and compassion, I am dedicated to advancing translational medicine through rigorous, ethical research that transforms scientific discoveries into real-world patient impact.
Sheavonnie Wright, MSc

Languages

English
Native language
Spanish
Intermediate (B1)
B1

Software

Clinical Trial & Data Management: Medidata Rave, REDCap, Clindex, CTMS platforms, Sponsor Portals, Epic EMR

Data Analytics & Statistical Tools: Microsoft Excel, Tableau, RStudio, SPSS, SAS

Collaboration & Project Management: Microsoft Teams, Smartsheet, Slack

Other: AI Training and implementation experience

Data Visualization & Reporting: Adobe Acrobat (PDF management), Google Data Studio, Excel PivotTables & Charts

Clinical Communication & Documentation: Microsoft Outlook, Zoom, DocuSign, SharePoint

Interests

Clinical Trial Management & Innovation

Translational Medicine

Patient Advocacy & Engagement

Public Health Research

Scientific Writing & Medical Communication

Spiritual Growth and Purpose-Driven Living

Community Engagement & Education

Middle School In-House Math Tutor (7th Grade) – Contract
SmartStart Education | January 2025 – June 2025

  • Facilitated daily small-group tutoring to reinforce core math concepts, improving academic outcomes through differentiated instruction.
  • Collaborated with teachers to align tutoring with curriculum objectives and maintain instructional consistency.
  • Designed interactive activities and exam prep strategies, increasing student engagement and boosting state assessment performance.

Urban Male Leadership Program (UMLP) – Member & Honoree
CUNY Lehman College | 2016–2020

  • Engaged in leadership and academic development programs empowering underrepresented students through mentorship, civic engagement, and professional growth.
  • Partnered with peers and campus leadership to advance community outreach, student success, and culturally responsive leadership initiatives.
  • Awarded Urban Female Leader of the Year (2020) for outstanding contributions and leadership excellence.

Websites

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