Regulatory Science Graduate & Clinical Data Integrity

AB

ALEXANDRA BURNS

*********.******.*****@*****.*** 919-***-**** Cary, NC 27519

Regulatory Science graduate student at the University of North Carolina at Chapel Hill with a strong clinical foundation in healthcare. Expertise in maintaining data integrity and executing complex clinical workflows in compliance with GCP and ICH guidelines. Proficient in Veeva Systems and eTMF frameworks. Actively pursuing entry-level opportunities in Clinical Research and Biopharma with an interest in Quality Assurance and Drug Development.

• Regulatory Affairs & FDA Frameworks

• Clinical Research & Trial Operations

• Clinical Protocol Compliance

• ICH-GCP Principles

• Drug Development Lifecycle

• IND/NDA Pathways

• Preclinical Development

• CMC & cGMP Fundamentals

• Data Integrity & Clinical Documentation

• ETMF & Veeva Systems

• Epic / EMR / EHR

• Specimen Handling & Phlebotomy

• EKG Acquisition & Urinalysis

• Patient Intake & Vital Signs

• Cross-Functional Collaboration

• HIPAA Compliance

Medi Weightloss Raleigh, NC

Medical Assistant

09/2025 - Current

Manage high-volume patient intake, including medical histories, medication information, vital signs, and clinical documentation within electronic medical record (EMR) systems.

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Perform phlebotomy, urinalysis, EKG acquisition, and specimen handling while maintaining accurate labeling, documentation, and specimen integrity.

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Administer subcutaneous and intramuscular injections in accordance with established clinical protocols, safety procedures, and patient-specific parameters.

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Coordinate with providers and clinical team members to maintain efficient patient flow, accurate documentation, and timely completion of clinical activities.

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Provide standardized education on treatment plans, medication guidance, lifestyle modifications, and follow-up requirements to support adherence and patient safety.

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Protect confidential patient information and maintain compliance with HIPAA and organizational policies during clinical care and data handling.

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New Hanover Regional Medical Center

Wilmington, NC

Respiratory Care Assistant

06/2024 - 06/2025

Supported respiratory therapists in high-acuity inpatient and acute-care environments.

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Collected and monitored clinically relevant data, including pulmonary function testing (PFT) and arterial blood gas (ABG) information, while maintaining accurate clinical documentation.

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Supported therapeutic workflows for patients with COPD, asthma, cystic fibrosis, and other cardiopulmonary conditions while following established clinical protocols.

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Summary

Skills

Experience

Worked across adult, pediatric, and neonatal patient populations, strengthening adaptability, communication, and attention to protocol- specific requirements.

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Maintained adherence to infection-control, patient-safety, equipment- readiness, and quality-assurance procedures in fast-paced clinical settings.

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Collaborated with interdisciplinary teams to communicate patient status and support accurate, timely clinical decision-making.

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Unite Methodist Church Carolina Beach,

NC

Nursery Leader

09/2023 - 05/2025

Supervised structured childcare operations, coordinating schedules, team assignments, safety procedures, and day-to-day logistics.

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Maintained attendance and administrative documentation while communicating consistently with parents, coordinators, and team members.

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Applied accountability, organization, risk awareness, and clear communication to support a safe and reliable operating environment.

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UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL Chapel Hill, NC Master of Professional Science (MPS) in Regulatory Science Expected in 2027

UNIVERSITY OF NORTH CAROLINA WILMINGTON Wilmington, NC Bachelor of Science in Respiratory Therapy, Minor: Clinical Research 05/2025

• linkedin.com/in/alexandra-burns

• Basic Life Support (BLS)

• Pediatric Advanced Life Support (PALS)

• Neonatal Resuscitation Program (NRP)

• Veeva Systems

• ETMF

• Epic Systems

• EMR/EHR

• Microsoft Excel

• Word

• PowerPoint

• Outlook

PHRS 700 – Drug Development: End-to-end drug development from discovery and preclinical research through Phase I–IV clinical development

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PHRS 701 – Fundamentals of Regulatory Affairs: FDA review processes, IND/NDA pathways, regulatory frameworks, and GCP/ICH principles

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PHRS 702 – Preclinical Development: Pharmacology, toxicology, safety assessment, ADME concepts, and IND- enabling studies

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PHRS 703 – Chemistry, Manufacturing, & Controls (CMC): cGMP, quality systems, formulation, analytical validation, stability, and manufacturing controls

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PHRS 890 – Regulatory Science Seminar Series: Industry trends, regulatory case studies, clinical trial operations, and evolving compliance considerations

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Education and Training

Websites, Portfolios, Profiles

Certifications And Technical Skills

Graduate Regulatory Science Coursework

Contact this candidate