Hannah Combs
Phoenix,USA
Summary
Leverage expertise in clinical and non-clinical research to enhance innovative methodologies and practices. Drive impactful research initiatives that prioritize human welfare and education while ensuring compliance with regulatory standards and best practices.
Overview
1
1
Certification
8
8
years of professional experience
Work History
Research Protocol Specialist
Mayo Clinic Cancer Center
Phoenix, US
04.2024 - Current
- Expertise in drafting, reviewing, and editing consent forms and regulatory documents in compliance with institutional, industry, and federal guidelines.
- Advanced proficiency in research systems and technology tools, including clinical, regulatory, legal, and integrative AI platforms.
- Independent management of protocol submissions, amendments, and consultative reviews with high accuracy and reliability.
- Leadership in mentoring and supporting team knowledge-building and best practice dissemination; oversight of study logistics, approvals, and communication with study sites, industry partners, and federal agencies.
- Quality assurance skills, including conducting quality checks to ensure compliance and process improvement.
- Project management experience leading complex or high-visibility research protocols and piloting new workflows through committee participation.
- Development of clinical trial funding proposals through the creation of patient care schedules, including the accurate allocation of research, Medicare, and standard-of-care charges in accordance with the clinical trial budget and contractual requirements.
- Clear understanding of Clinical Trial Activation processes and policy to ensure timely activations.
- Development and review of clinical trial budgets; strategic guidance on regulatory and policy requirements to investigators, Sponsors, and research staff.
- Coordination and management of clinical research documents, including writing and editing Informed Consent Forms to ensure compliance.
- Uphold all guidelines and practices under HIPAA, GLP, GCP, and GDP per Mayo Clinic Policy.
- Adaptability to fast-paced environments and evolving departmental priorities, maintaining composure and dependability under pressure.
- Constructive response to feedback and solution-oriented approach to challenges.
- Active participation in departmental and cross-functional initiatives, work groups, and improvement projects.
- Balancing multiple complex projects simultaneously while working independently and collaboratively with minimal supervision.
- Demonstrates sound judgment in navigating ambitious and high-pressure situations.
Clinical Research Coordinator
Mayo Clinic Cancer Center
Phoenix, US
03.2022 - 04.2024
- Uphold all guidelines and practices under HIPAA, GLP, GCP, and GDP per Mayo Clinic Policy.
- Maintaining research records of study activity, including case report forms, drug dispensation records, or other regulatory forms as per FDA, regulatory, and institutional guidelines.
- Oversees and monitors research data over the course of multiple clinical trials.
- Reviews, recruits, screens, and enrolls participants for clinical studies.
- Schedules all tests and procedures per protocol and institutional guidelines.
- Participates in meetings by updating supervisors, Principal Investigators (PIs), and Sponsors on progress, results, and future studies.
- Educates and leads fellow staff in new and updated facility guidelines and practices.
- Adheres and facilitates laboratory protocols.
- Communicates with study participants regarding study objectives.
- Making sure that all equipment and supplies needed for the study are in-stock and in good working order.
- Managing budgets set aside for research.
Research Assistant
Midwestern University
Glendale, US
11.2020 - 03.2022
- Independently executes Biochemistry/Cellular Oncology and chemotherapy-based agent studies in rodents.
- Wrote Grants, Protocols, Papers, and Scientific Writing for students and faculty.
- Collaborated with large multi-center clinical research departments, PIs, and researchers within Midwestern University’s diverse research department.
- Mentored students and other staff on proper protocols, experiments, and research related tasks in wet lab and field setting.
- Educated and facilitated research projects for students during the school year for Poster presentations.
- Educated students and staff on Non Clinical Wet Lab, Biochemistry, Animal behavior, and husbandry related processes.
- Maintains detailed laboratory records, files, documents, and data for scientific publications.
- Adheres and facilitates Sponsor, CRO, and local laboratory protocols.
- Collection, analysis, and assessment of data using statistical and analytical methods.
- Presents posters and data to internal and external research organizations.
- Participates in weekly lab meetings by updating department and Sponsors of progress, data, and future studies.
- Acted as Lead Coordinator and Lab Manager of the Biochemistry and Molecular Genetics Lab.
- General Non-Clinical and Clinical research laboratory management and duties.
- Prioritizes daily laboratory experiments.
- Performs necropsies and other specialized non-clinical surgeries.
- Organizes lab stocks, lists, and inventory.
- Performs animal husbandry on murine colony.
- Performs a variety of Animal Behavior experiments.
- Performs a variety of Histology and Biorepository related research.
Research Associate I
Translational Drug Development, TD2
Scottsdale, US
02.2019 - 11.2020
- Executes In Vivo Pharmacology studies in rodents.
- Collaborated with large multi-center clinical research departments, CROs, and companies.
- Maintains detailed laboratory files and documents.
- Adheres and facilitates Sponsor and local study protocols.
- Collection, analysis, and assessment of data using statistical and analytical methods.
- Participates in weekly lab meetings by updating department and Sponsors of progress, data, and future studies.
- Performs general laboratory duties and maintains laboratory standards.
- Performs necropsies and other related non-clinical surgeries.
- Performs all non-clinical laboratory duties as assigned.
- Prepare for and execute assigned pharmacology studies.
- In Vivo Pharmacology
Education
B.S. - Biology
Northern Arizona University
Flagstaff, AZSkills
- Clinical Trial Activation & Start-Up
- Clinical Trial Budgeting & Financial Management
- Clinical Trial Budget Variance and Feasibility
- Creation of Patient Care Schedules following both institutional, Research, and Medicare association adherence
- Clinical Research Operations
- Clinical Research and Regulatory Compliance (HIPAA, ICH-GCP guidelines, FDA rules, GLP, GDP, IRB, NIH, USDA, and local regulation)
- Regulatory Document Development & Review
- Quality Assurance & Process Improvement
- Project Management
- Research Systems, Technology Platforms & AI Applications (EDCs, EPIC, TCN, Copilot, CTMS, Medidata Rave etc)
- Data & Database Management
- Protocol Submission & Amendment Management
- Informed Consent Development
- Statistical Analysis
- Clinical Oncology Research
- Non-Clinical Oncology Research
- In Vivo Pharmacology
- Scientific & Grant Writing
- Study Logistics, Stakeholder Engagement & Communication
- Mentorship
- Staff Training & Education
- Cross-Functional Collaboration
- Strategic Problem Solving
- Decision-Making
- Adaptability
- Time Management & Multitasking
Certification
- The Institutional Animal Care and Use Committee, 09/01/17, Present, Certification proving, I have completed all tests within the Collaborative Institutional Training Initiative and am certified to conduct research and care for animals meeting the Department of Agriculture (USDA) and Office of Laboratory Animal Welfare (OLAW).
- CITI Training, 09/01/17, Present, Certification proving both Clinical and Non-Clinical Research testing completed per IRB, NIH, and Regulatory guidelines.
Awards
- 2020, Grant Funded Research Assistant Position Midwestern University
- 2017, ASNAU Travel Grant Evolution Conference- $3,000
- 2017, Arizona Nevada Academy of Sciences Grant- $200
- 2017, Best Presentation Award Arizona Nevada Academy of Sciences- $50
Personal Information
Work Permit: Authorized to work in the US for any employer.
Timeline
Research Protocol Specialist
Mayo Clinic Cancer Center
04.2024 - Current
Clinical Research Coordinator
Mayo Clinic Cancer Center
03.2022 - 04.2024
Research Assistant
Midwestern University
11.2020 - 03.2022
Research Associate I
Translational Drug Development, TD2
02.2019 - 11.2020
B.S. - Biology
Northern Arizona University