Victoria Ingram

September 2024 - Current

Protocol Title: EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence.

Sponsor Name: Eli Lilly and Company

Study Drug: Imlunestrant (LY3484356)

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September 2024 - Current

Protocol Title: CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence

Sponsor Name: AstraZeneca AB

Study Drug: Camizestrant

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September 2024 - Current

Protocol Title: AstraZeneca / “CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next-Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients with ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease”

Sponsor Name: AstraZeneca

Study Drug: Camizestrant

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September 2024 - Current

Protocol Title: A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)

Sponsor Name: AstraZeneca AB

Study Drug: Datopotamab deruxtecan (Dato-DXd) in combination with durvalumab

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June 2023 - September 2024

Protocol Title: Patterns and Consequences of Injuries Occurring in Collisions of Vehicles with Modern Occupant Protection Systems (CIREN)

Sponsor Name: National Highway Traffic Safety Administration (NHTSA) of the Department of Transportation (DOT)

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December 2023 - September 2024

Protocol Title: The Impact of Provider on the Appropriate Use of Prehospital Tourniquets

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February 2024 - September 2024

Protocol Title: Assessing the Role of Routine Imaging After Chest Wall Trauma

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September 2021 - June 2022

Tazemetostat for the Treatment of Pediatric Patients with Malignant Rhabdoid Tumors and Other INI1-Negative Tumors

Study Drug: TAZVERIK (Tazemetostat)

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• Explains basic elements of research studies and subject safety to research participants.
• Explains and performs study activities in compliance with Good Clinical Practice (GCP) and federal regulations.
• Pre-screens, screens, and enrolls patients for study eligibility.
• Coordinates with principal investigators to fulfill the day-to-day clinical research operations, including tracking adverse events, monitoring concomitant medications, etc.
• Performs EKGs on applicable research participants.
• Take research participants' vitals for applicable research studies.
• Manages research enrollment for multiple studies.
• Adheres to study protocols and regulatory requirements.
• Assist patients with research-specific inquiries.
• Corresponds with study sponsors.
• Supports team members with additional tasks.
• Documents all research participant activity via EPIC

• Coordinated study start-up activities for multiple studies, including drafting protocols, consent forms, contracts, and budgets.
• Pre-screened, screened, and enrolled patients for trauma research studies.
• Explained and performed study regulatory activities in compliance with Good Clinical Practice (GCP) and federal regulations.
• Communicated study purpose, and provided education across departments, schools, and community events.
• Coordinated with surgeons for study presentations.
• Presented Crash Investigation Research Engineering Network (CIREN) data to various surgeons, nurses, schools, and students.
• Extracted medical records and injuries from EPIC.
• Supported Trauma team members with additional Trauma Services projects.
• Maintained and standardized program patient screening lists via study share drive.

• Collected and maintained required IND forms.
• Maintained drug supply distribution via CTMS and program share drive.
• Collected all regulatory documents from site physicians – licensure, import permits (for out-of-country sites), etc.
• Oversight of the supply chain team to coordinate the dispatch of investigational products according to WEP Clinical's SOPs.
• Prepared Investigational Product Review Forms (IPRFs) for review.
• Monitored temperature log deviations.
• Educated sites, physicians, and study personnel on proper handling of IP.
• Screened and enrolled eligible pediatric cancer patients for the Expanded Access Program (EAP).
• Communicated with oncologist and sites for EAP enrollment.
• Monitored SAEs and AEs, and communicated those cases to all enrolled study sites.
• Assisted with the development and execution of new projects.
• Worked with the project management team to ensure project duties are completed in accordance with client expectations and Good Clinical Practice.
• Provided support to Project Management Leadership on various projects.
• Organized and maintained shared program-level documents within internal OneDrive or SharePoint.

• Lead Analyst for prominent pharmaceutical companies for all COVID-19 regulatory documents.
• Reviewed regulatory documents submitted by sponsors, sites, and CROs to ensure ethical standards were met.
• Managed multiple high-turnaround time work orders for the department.
• Provided CROs, sites, and sponsors with feedback regarding regulatory documents to ensure accordance with ethical guidelines.
• Translated consent forms and other required clinical research documents.
• Onboarded and trained a new analyst.
• Monitored Key Performance Indicators for the department.
• Board member for enhancing educational advancement for the department.