Amber Neal
Kennebunk
Summary
Results-oriented research leader with 10+ years of experience directing complex Phase I-IV oncology clinical research trials, ensuring regulatory compliance, and driving project milestones. Recognized for spearheading strategic transformations, optimizing clinical trial delivery, and scaling site networks for growth.
Proven track record in leading cross-functional teams, improving site performance, and aligning business objectives with quality and compliance standards. Adept in navigating global regulatory frameworks, building strong sponsor and stakeholder relationships, and delivering trial excellence.
Overview
2026
2026
years of professional experience
1
1
Certification
Work History
Research Project Manager, Phase I Program
Harold C. Simmons Comprehensive Cancer Center | University of Texas Southwestern Medical Center
2024 - Current
- Oversee the pipeline of 15 NCI-, grant-, and sponsor-funded solid tumor and malignant hematology research trials, manage project timelines and track milestones, reducing protocol activation timelines by 68% in the past year.
- Develop of the Phase I Program through identification of gaps in treatment areas, seeking potential clinical trials, and collaboration with stakeholders and sponsors to define project scope, goals, and deliverables, increasing pipeline trials from 7 per year to 15 per year.
- Coordinate and strategic planning of regulatory requirements, serving as the Phase I team point of contact, and providing resources to meet deadlines.
- Schedule and conduct pre-site selection visits and site initiation visits.
- Serve as Co-Chair of the SOP Committee, reviewing and updating Standard Operating Procedures (SOP) since 2019.
- Led multidisciplinary teams in executing research initiatives, ensuring alignment with project goals and timelines.
- Developed and implemented project plans, enhancing operational efficiency and resource allocation.
Clinical Research Manager, Phase I Program
Harold C. Simmons Comprehensive Cancer Center | University of Texas Southwestern Medical Center
01.2021 - 01.2024
- Managed team day-to-day operations of 7 research professionals, including Senior Research Nurses, Clinical Research Coordinators, and Data Specialists coordinating an average of 25 active, 25 open/closed to enrollment, and 15 pipeline research trials.
- Maintain in-depth protocol knowledge across multiple therapeutic areas and indications, ensuring adherence to study procedures and data quality standards.
- Played a key role in quality assurance by responding to audits and implementing effective and measurable corrective action plans, reducing repeat findings by 95%.
- Increased study accrual rates by greater than 400% through ongoing study management activities, including development of clinical informatics searches of electronic medical records and program-specific referral in EPIC.
- Evaluated the performance of individual studies against established benchmarks, identifying areas for potential improvement.
- Collaborated with Patient Navigator to support a Stand Up to Cancer grant with the goal of promoting diverse and equitable access to early-phase cancer clinical trials, resulting in 50% of the participants enrolling in the Phase I Program across 6 program areas.
- Entered and verified patient data starting at screening, including treatment, through follow-up.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Maintained compliance with protocols covering patient care and clinical trial operations.
Research Project Manager, Phase I Program
Harold C. Simmons Comprehensive Cancer Center | University of Texas Southwestern Medical Center
2020 - 2021
Senior Protocol Activation Coordinator
Harold C. Simmons Comprehensive Cancer Center | University of Texas Southwestern Medical Center
01.2018 - 01.2020
- Developed and maintained Phase I-IV oncology research trial project timelines for site initiation, navigating the scientific and safety review process, ensuring adherence to deadlines across multiple departments.
- Drafted and negotiated budgets with government agencies, private organizations, and pharmaceutical companies.
- Trained and mentored junior staff on best practices in project coordination and compliance protocols.
- Analyzed workflow patterns to identify bottlenecks, recommending solutions that improved process efficiency.
Protocol Activation Coordinator
Harold C. Simmons Comprehensive Cancer Center | University of Texas Southwestern Medical Center
2016 - 2018
Grants Administrator
Harold Simmons Foundation
01.2013 - 01.2015
- Managed grant application processes, ensuring compliance with funding requirements and internal policies.
Administrative Manager
Space Plasma Physics Theory Group | University of New Hampshire
01.2004 - 01.2013
- Guided researchers in the preparation of grant proposals.
- Streamlined administrative processes to enhance operational efficiency within research group.
- Coordinated scheduling and logistics for conferences, meetings, and collaborative research projects.
- Managed budgetary allocations and financial reporting to ensure resource optimization.
Education
Bachelor of Science - Biology
University of New Hampshire
Durham, NH01.2002
Skills
- Clinical Trial Management: Study Start-up Feasibility Site Management Protocol Adherence Recruitment & Enrollment
- Project Management: Timeline & Budget Management Deliverable Tracking Risk Identification & Mitigation Stakeholder Communication
- Regulatory & Compliance: IRB Submissions, FDA/ICH-GCP, HRPP Compliance
- Electronic Data Capture: Inform Medidata Rave Clario REDCap Medrio Veeva Vault
- Clinical Trial Management Systems: eIRB ETHOS Velos Florence EPIC
Accomplishments
Siglinsky, E., Phan, H., Meletath, S., Neal, A., Gerber, D. E., Rahimi, A., Williams, E. L. (2025) “Design and refinement of clinical trial staffing model within the evolving landscape of oncology clinical trials.” Contemporary Clinical Trials Communications, vol. 45, article 101485.
Neal, A., Jefferson, T. (2024) “Enhancing Research Study Team Coordination of Trial Initiation to Reduce Time to Activation.” UTSW Celebration of Excellence, #100.
Certification
- Certified Clinical Research Professional, Society of Clinical Research Associates - 2019
- Lean Six Sigma Yellow Belt - 2017
- Leadership Foundations - 2022
- Performance Excellence and Quality Management - 2023
- BLS Heart Saver - 2018
- Good Clinical Practice (GCP) Certified - 2016
- Human Research Protection (HSP) Certified - 2016
- International Air Transport Association (IATA) Dangerous Goods Certified - 2020
- NIH-NCI Registered - 2016
Timeline
Clinical Research Manager, Phase I Program
Harold C. Simmons Comprehensive Cancer Center | University of Texas Southwestern Medical Center
01.2021 - 01.2024
Senior Protocol Activation Coordinator
Harold C. Simmons Comprehensive Cancer Center | University of Texas Southwestern Medical Center
01.2018 - 01.2020
Grants Administrator
Harold Simmons Foundation
01.2013 - 01.2015
Administrative Manager
Space Plasma Physics Theory Group | University of New Hampshire
01.2004 - 01.2013
Research Project Manager, Phase I Program
Harold C. Simmons Comprehensive Cancer Center | University of Texas Southwestern Medical Center
2024 - Current
Research Project Manager, Phase I Program
Harold C. Simmons Comprehensive Cancer Center | University of Texas Southwestern Medical Center
2020 - 2021
Protocol Activation Coordinator
Harold C. Simmons Comprehensive Cancer Center | University of Texas Southwestern Medical Center
2016 - 2018
Bachelor of Science - Biology
University of New Hampshire