Clinical Trial & Data Management: Medidata Rave, REDCap, Clindex, CTMS platforms, Sponsor Portals, Epic EMR
Sheavonnie Wright, MSc.
Clinical Research Associate
Summary
Clinical Research Associate with leadership experience overseeing CRC teams and coordinating multi-specialty Phase I–III trials in oncology, transplant, and academic settings. Skilled in protocol adherence, patient-focused informed consent, regulatory document management, and maintaining inspection-ready TMFs in line with ICH-GCP, FDA, and HIPAA standards.
Proven success driving process improvements—developing tools that increased scheduling accuracy by 40% and directly contributing to zero-finding FDA audits. Collaborated closely with PIs, sponsors, monitors, and cross-functional teams to safeguard data integrity, resolve protocol deviations, and uphold patient safety.
Grounded in rigorous scientific training from NIH/NHLBI through advanced translational research, and a published author in peer-reviewed journals. I bring operational excellence, collaborative leadership, and a long-term commitment to advancing compassionate, compliant clinical research.
Overview
5
5
years of professional experience
14
14
CITI Program Certifications Completed
14
14
Clinical Trials Supported across various therapeutic areas
4
4
Therapeutic areas: Oncology, Nephrology, Neuroscience, Cardio.
50
50
Patients Registered and Managed Across Trials
3
3
High-Impact Publications Contributed To
Work History
Clinical Research Associate
Memorial Sloan Kettering Hospital Cancer Center
New York, USA
07.2024 - 12.2024
- Managed up to 10 concurrent Phase I–III oncology trials, overseeing patient scheduling, protocol compliance, and data capture to meet sponsor milestones while prioritizing patient safety.
- Created Excel-based tools that improved scheduling accuracy by 40%, directly supporting a zero-finding FDA audit and enhancing overall operational efficiency.
- Acted as the primary liaison with sponsors, PIs, IRBs, FDA, and internal teams—resolving over 50 protocol deviations through timely documentation, IRB submissions, and patient re-consents.
- Prepared and maintained complete regulatory documentation, ensuring 100% audit-ready TMFs, eReg binders, and source documents across multiple protocols.
- Led weekly team meetings and trained new CRCs on ICH-GCP, protocol specifics, and institutional SOPs, driving a 30% improvement in protocol adherence and a 98% on-time completion rate for study assessments.
- Managed biospecimen tracking and chain-of-custody, coordinating with lab teams to ensure secure transfers, accurate labeling, and protocol-aligned processing for downstream analyses.
- Supported sponsor monitoring visits and interim analyses by addressing data queries, reconciling discrepancies, and maintaining full inspection readiness.
Clinical Research Technician I
Weil Cornell Medicine
New York, USA
10.2022 - 07.2024
- Supported kidney transplant clinical trials, managing patient assessments, coordinating visits to align with protocol windows, and ensuring compliance with sponsor and FDA guidelines.
- Oversaw biospecimen collection and logistics, maintaining precise clinic-to-lab documentation and preserving chain-of-custody across 5 active transplant protocols.
- Performed molecular lab techniques including mRNA extraction and RT-qPCR analysis to generate high-quality gene expression data that directly informed study endpoints.
- Collaborated closely with surgeons, nephrologists, transplant nurses, and lab technicians to troubleshoot procedural issues and uphold stringent GCP standards.
- Co-authored peer-reviewed publications in The American Journal of Transplantation by translating clinical and laboratory data into impactful manuscripts that advanced transplant research.
Research Technician
Henderson Lab at Marshall University
Huntington, USA
01.2021 - 06.2022
- Conducted NIH-funded studies investigating vape-related neurotoxicity, managing N2A cell cultures, transient gene transfections, and preparing fluorescent microscopy samples.
- Used ImageJ and quantitative analysis to assess the stoichiometric effects of vape flavorants on nicotinic acetylcholine receptor (nAChR) signaling pathways.
- Developed and optimized laboratory protocols, troubleshooting experimental challenges to ensure reproducibility and high data integrity.
- Contributed to two peer-reviewed publications in The Journal of Neuroscience and Nicotine & Tobacco Research, advancing the field’s understanding of vape impacts on neurobiology.
Internship Student
National Institutes of Health, NHLBI
Bethesda, MD
06.2017 - 08.2019
- Completed two competitive summer internships in the Laboratory of Vascular and Matrix Genetics under Dr. Beth Kozel, M.D., Ph.D., contributing to translational research on vascular biology and extracellular matrix genetics.
- Assisted in experimental design, sample processing, and preliminary data analysis for NIH-funded studies, honing core scientific and analytical skills.
- Engaged in multidisciplinary lab meetings and collaborative projects, gaining foundational experience in rigorous research methodology at a premier national institute.
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, NYSkills
Technical & Analytical Skills
- Proficient in EDC, CTMS, EMR, and REDCap systems for accurate data capture and streamlined reporting
- Thorough knowledge of GCP, FDA, and ICH guidelines driving robust study conduct and regulatory adherence
- Experienced in AE/SAE reporting, source data verification (SDV), protocol deviation tracking, and informed consent documentation
- Prepared for FDA audits and adept at data query resolution to maintain audit-ready sites
Operational & Organizational Skills
- Oversaw multi-site monitoring activities aligned with risk-based monitoring plans
- Managed regulatory binders, IRB submissions, and amendments to maintain inspection readiness
- Coordinated SIVs, SQVs, and supported audits with meticulous preparation
- Facilitated cross-functional collaboration among clinical, lab, and sponsor teams for seamless trial execution
Soft Skills / Interpersonal Strengths
- Strong communicator liaising between sponsors, PIs, site teams, and regulatory bodies
- Effective mentor training new CRCs and fostering cohesive, high-performing teams
- Strategic problem solver thriving under deadlines in complex, multi-protocol environments
- Detail-oriented and adaptable, managing multiple studies and shifting priorities with ease
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:
• BLS Healthcare Provider – Scheduled August 2025
• Eligible for CCRC/CCRP certification within 1 year (ACRP/SOCRA)
Accomplishments
- Spearheaded protocol adherence initiatives that boosted compliance by 30%, leveraging collaborative leadership and streamlined operational workflows.
- Supported FDA inspections with zero findings by maintaining 100% data accuracy and audit readiness across CTMS, REDCap, EMR, and sponsor platforms.
- Co-authored peer-reviewed publications in The Journal of Neuroscience, Nicotine & Tobacco Research, and Transplantation; most recently contributed to a Kidney Medicine research letter on microbiota in hemodialysis patients.
- Managed data integrity and regulatory documentation across multisite trials using Medidata Rave, Vault, EPIC, and Smartsheet, ensuring real-time compliance and sponsor reporting.
- Consistently exceeded enrollment targets and accelerated visit timelines while upholding rigorous ethical standards and patient-centered care.
Publications
- Impact of Ultrasound-Guided Percutaneous Core Needle Biopsy on Biomarkers of Human Kidney Allograft Status. Transplantation. 2024. PMID: 40048628
- Chemical Flavorants in Vaping Products Alter Neurobiology in a Sex-Dependent Manner to Promote Vaping-Related Behaviors. Journal of Neuroscience. 2023. PMID: 36690450
- Morphine Exposure Reduces Nicotine-Induced Upregulation of Nicotinic Receptors. Nicotine & Tobacco Research. 2022. PMID: 34999827
Work Preference
Work Type
Full TimeWork Location
On-SiteHybridImportant To Me
Career advancementWork-life balanceCompany CulturePersonal development programsHealthcare benefitsWork from home optionPaid sick leave401k matchStock Options / Equity / Profit SharingTeam Building / Company RetreatsSoftware
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
Languages
English
Native language
Spanish
Intermediate (B1)
B1
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
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.
Timeline
Clinical Research Associate
Memorial Sloan Kettering Hospital Cancer Center
07.2024 - 12.2024
Clinical Research Technician I
Weil Cornell Medicine
10.2022 - 07.2024
Research Technician
Henderson Lab at Marshall University
01.2021 - 06.2022
Internship Student
National Institutes of Health, NHLBI
06.2017 - 08.2019
MSc - Biomedical Research with Medical Science and Research Emphasis
Marshall University Joan C. Edwards School of Medicine
BA - Chemistry with a Concentration in Biochemistry
The City University of New York: Herbert H. Lehman College
Similar Profiles
Tracy McNamaraTracy McNamara
Clinical Nurse II in Chemotherapy Infusion at Memorial Sloan Kettering Hospital Cancer CenterClinical Nurse II in Chemotherapy Infusion at Memorial Sloan Kettering Hospital Cancer Center
Yohannes Abere AmbawYohannes Abere Ambaw
POSTDOCTORAL RESEARCH ASSOCIATE at Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute, Cell Biology DepartmentPOSTDOCTORAL RESEARCH ASSOCIATE at Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute, Cell Biology Department
Penelope FiguereoPenelope Figuereo
Patient Care Technician , Pediactric Care Unit at Memorial Sloan Kettering Cancer Center HospitalPatient Care Technician , Pediactric Care Unit at Memorial Sloan Kettering Cancer Center Hospital
Henrietta T. BaahHenrietta T. Baah
Senior Clinical Research Associate II/ Lead Clinical Research Associate at Fortrea (Formerly LabCorp Drug Development)Senior Clinical Research Associate II/ Lead Clinical Research Associate at Fortrea (Formerly LabCorp Drug Development)
Denishia DyleDenishia Dyle
Clinical Research Patient Recruiter /Senior Clinical Research Associate at Accel ClinicalClinical Research Patient Recruiter /Senior Clinical Research Associate at Accel Clinical