MADELEINE WOOD, RN
New York,NY
Summary
Clinical research and nursing professional with strong background in chart abstraction, data entry, and emergency nursing. Experienced with maternal health and pediatrics. Skilled in collaborating with multidisciplinary teams, adapting to dynamic situations, and prioritizing patient needs. Known for effective communication, empathy, and resilience under pressure. Reliable team player focused on delivering high-quality care and positive outcomes.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Staff Nurse, Emergency Department
New York City Health and Hospitals/Harlem Hospital
New York, NY
04.2025 - Current
- Provide high-acuity emergency nursing care in both adult and pediatric emergency departments.
- Member of Shared Governance, contributing to policy development and quality improvement initiatives.
- Trained in peer chart review, evaluating documentation for accuracy, quality, and compliance.
- Collaborate with interdisciplinary teams to optimize patient outcomes and workflow efficiency.
Clinical Research Project Manager
Weill Cornell Medical Center
New York, NY
09.2024 - 03.2025
- Led cross-functional teams in executing international and multi-site cardiothoracic surgery clinical trials, ensuring adherence to protocols and regulatory requirements.
- Supported multi-million dollar grant submissions, monitored awarded grant progress, and provided deliverables for awarding agency monitoring
- Developed project timelines and milestones, optimizing resource allocation for efficient study progression.
- Mentored junior staff, fostering professional development and enhancing team performance in project delivery.
- Coordinated communication between stakeholders, facilitating collaboration and alignment on project objectives.
- Analyzed data trends to inform strategic decision-making and adjust project plans as necessary.
Regulatory and Protocol Development Specialist
Weill Cornell Medicine
New York, NY, USA
01.2022 - 09.2024
- Developed scope of work and responsibilities within my current role
- Experience with the complete life span of Phase I and II oncology trials across all body system; includes drug, device, and gene/cell therapy trials, with a focus on investigator- initiated trials (IITs)
- Collaborate with principal investigators (PIs) to develop phase I and II protocols that meet FDA and GCP/ICH standards
- Development of informed consent forms and trial manuals
- Complete IND and IDE applications and consult on regulatory strategies for early- phase drugs and devices
- Manage clinicaltrials.gov records for trials across the Meyer Cancer Center, ensuring compliance with federal reporting requirements
- Completion of submissions to Data Safety & Monitoring Committees
- Facilitate and standardize the start- up process for IITs and identify ways to decrease time to activation metrics in accordance with the center's goals
- Provide training to Clinical Research Specialists, Program Managers, and Investigators on responsibilities as a Sponsor, FDA regulations, safety monitoring and reporting, and protocol development
- Review regulatory and clinical trial operations processes to proactively address potential issues
- Coordinate and collaborate with multi- disciplinary teams to ensure successful working relationship both internally and externally with CROs and pharmaceutical companies
- Cancer Clinical Trials Office
Clinical Research Coordinator (Regulatory)
Cardiothoracic Surgical Trials Network (CTSN) Data Coordinating Center at Mount Sinai School of Medicine
New York, NY, USA
11.2020 - 12.2021
- Performed regulatory, monitoring, and clinical trial manager duties for Phase III international and domestic multi- site clinical trials, including cardiothoracic surgery; pulmonary/critical care; and infectious disease trials
- Reviewed and managed regulatory documents for multiple, large multi- site clinical trials (US and Canada)
- Worked closely with site coordinators to ensure appropriate documentation
- Performed site activations
- Managed electronic trial master files in order to maintain FDA- audit readiness
- Trained new Regulatory Coordinators
- Performed site monitoring visits in accordance with risk-based monitoring plans, and completed post-visit monitoring reports
- Conducted comprehensive chart reviews to ensure protocol adherence and data accuracy.
- Generated data reports to track overall trial and local site progress
- Monitored adverse events, confirm completeness and accuracy of forms, code events, submit appropriate documentation to medical monitors and the FDA
- Confirmed milestones for site reimbursements. Regularly communicated with site coordinators via email, phone calls, and queries issued in the EDC
- Performed internal audits to ensure inter- monitor consistency across sites
Study Coordinator
Upper Manhattan Mental Health
New York, NY, USA
05.2018 - 08.2018
- Recruited participants and obtained informed consent according to principles of GCP
- Collected vitals and administered surveys with patients per study protocol
- Performed data entry
- Optimized clinic workflow
- Supervised research staff
Research Technician
Weill Cornell Medicine
New York, NY, USA
06.2016 - 04.2018
- Collaborated with pharmaceutical companies and academic institutions on pre- clinical antibiotic development to treat Mycobacterium tuberculosis
- Performed drug screening in a Biosafety Level 3 facility ensuring both generation of high-quality data and safety of researchers
- Trained and supervised new laboratory members
- Microbiology & Immunology Department
Research Assistant
Cornell University
New York, NY, USA
09.2012 - 05.2016
- Participated in development, implementation, and evaluation of community interventions to improve women's health
- Developed and managed surveys to obtain behavioral and clinical data from study participants and performed content analysis of survey responses
- Contacted study participants to complete dietary recall surveys and for study reminders
- Entered and cleaned data
- Monitored data for quality control
- Adapted study materials for widespread dissemination to participants
- Performed cost analysis on intervention equipment and created site supply budgets
- Conducted literature reviews
- Prepared written reports of summarizing findings
- Maintained website content
- Division of Nutritional Science
Education
Associates Degree - Nursing
Borough of Manhattan Community College
New York, NY12.2024
Bachelor of Science - Human Biology, Health & Society
Cornell University
Ithaca, NY05.2016
Skills
- Emergency Nursing
- Clinical Research
- Training/Mentoring
- Chart Review
- Project Management/Coordination
- Database Management
- GCP/ICH
- Clinical Trial Monitoring
- Protocol Development
- Regulatory Affairs/Compliance
- Medical Writing
- Data Analysis
- Qualtrics, REDCap, Microsoft Office, Epic Systems, Electronic Data Capture Systems, Adobe Systems, Florence eTMF, OnCore
- Emergency Medical Technician Experience
- Comprehensive Clinical Knowledge
Certification
- BLS
- ALS
- PALS
- TNCC
Timeline
Staff Nurse, Emergency Department
New York City Health and Hospitals/Harlem Hospital
04.2025 - Current
Clinical Research Project Manager
Weill Cornell Medical Center
09.2024 - 03.2025
Regulatory and Protocol Development Specialist
Weill Cornell Medicine
01.2022 - 09.2024
Clinical Research Coordinator (Regulatory)
Cardiothoracic Surgical Trials Network (CTSN) Data Coordinating Center at Mount Sinai School of Medicine
11.2020 - 12.2021
Study Coordinator
Upper Manhattan Mental Health
05.2018 - 08.2018
Research Technician
Weill Cornell Medicine
06.2016 - 04.2018
Research Assistant
Cornell University
09.2012 - 05.2016
Associates Degree - Nursing
Borough of Manhattan Community College
Bachelor of Science - Human Biology, Health & Society
Cornell University