Whitney E.
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Whitney E. Email & Phone Number

Veeva Vault eTMF and Document Lead at SystImmune
Location: Raleigh, North Carolina, United States 11 work roles 1 school
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Current company
Role
Veeva Vault eTMF and Document Lead
Location
Raleigh, North Carolina, United States
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Whitney E. is listed as Veeva Vault eTMF and Document Lead at SystImmune, a company with 92 employees, based in Raleigh, North Carolina, United States. AeroLeads shows a matched LinkedIn profile for Whitney E..

Whitney E. previously worked as Clinical Trial Assistant at Systimmune and In House Clinical Research Associate at Icon Strategic Solutions. Whitney E. holds Bachelor'S Degree, Public Health: Community Health from East Carolina University.

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SystImmune

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Profile bio

About Whitney E.

A clinical trials assistant and business professional with exceptional interpersonal, communication and management skills, who is committed to helping to improve the health and wellbeing of individuals. Knowledge of clinical research regulations and guidelines (e.g. ICH-GCP, FDA regulations). Experience in clinical trial management and monitoring. Strong communication and interpersonal skills. Attention to detail and ability to manage multiple tasks simultaneously. Ability to work independently and as part of a team. Proficiency in MS Office and other relevant programs (e.g. CTMS, Veeva Vault). Excellent organizational and time management skills. Ability to analyze and interpret clinical data. Knowledge of medical terminology and clinical trial documentation. Ability to identify and resolve issues related to clinical trial conduct and data quality.

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Whitney E.'s current company

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SystImmune
Systimmune
Veeva Vault eTMF and Document Lead
Raleigh, NC, US
Website
Employees
92
AeroLeads page
11 roles

Whitney E. work experience

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Veeva Vault Etmf And Document Lead

Raleigh, NC, US

Clinical Trial Assistant

Current

Redmond, Washington, United States

  • Develop and distribute meeting agendas, minutes and monthly status reports to documentkey project updates and communications to relevant stakeholders, as requested.
  • Participate in regular team meetings / teleconferences; CRO, Vendor and Investigator Sitemeetings as necessary; and Investigator Meetings, as necessary.
  • Support Clinical Project Management team in communication to CRO, Vendors andInvestigator Sites.
  • Support the Clinical Project Management team with study start-up activities, to includepreparing and/or reviewing study-related documents (e.g., Monitoring Plan, Laboratory Manual, Clinical Site Procedures Manual.
  • Support the Clinical Project Management team in the tracking of subject recruitment at all study sites; monitoring visits and approval; infringements, breaches, and misconduct, fraud, and negative trends and protocol.
  • Assist Clinical Project Management team in the collection, review and filing of site Essential Documents, and maintenance of the TMF.
Sep 2023 - Present

In House Clinical Research Associate

Raleigh, North Carolina, United States

  • Manage Study Master File(s)
  • Documentation and collection of study contracts
  • Request and collect Regulatory Docs, FDF, CV, GCP and ML
  • Review and approval of subset documents in applicable databases
  • Process core study documents ( upload, assigning of attributes, filing, review and approvalof subset of documents in eTMF)
  • Ensure successful study start up
Aug 2022 - Oct 2023

Clinical Project Assistant Ii

Raleigh, North Carolina, United States

  • Clerical Review and assist in the process in accordance with SOPs, incoming SeriousAdverse Event (SAE) forms, including site follow-up for resolution of data inquiries, assist in distribution of IND Safety Letters to.
  • Coordinates with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of a clinical trial. Assures currency of required clinical trial documents within.
  • Maintains clinical grant tracking database for each study, generates periodic reports on status of grant payments and resolves payment inquiries from investigator sites.2
  • Assists CPL/CRA in preparing and tracking investigational product (IP) supplies, packaging, and shipment requests and circulating these requests for appropriate approvals.
  • Confirms site receipt of shipped IP, alerts responsible CPL whenever IP inventory requires review/re-order and assists with drug reconciliation.
Aug 2021 - Aug 2022

Clinical Trials Assistant Ii

Durham, North Carolina, United States

Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical.

Nov 2020 - Aug 2021

Patient Access Advocate

Durham, North Carolina, United States

Proactively build trusting relationships with patients, providers, or other stakeholders ensuring their best interests are met.Act as a patient advocate ensuring all existing barriers impeding a needed therapy are identified and necessary steps are taken to remove them.Manage and respond to incoming calls and determine how best to meet the needs of the.

Aug 2020 - Nov 2020

Healthcare Ambassador

Raleigh-Durham-Chapel Hill Area

Actively engage with patients both in home and over the phone.Building rapport relationships with patients and caregiversHelp patients understand the value of the Landmark program, and how best to use its services.Conduct surveys with patients Contribute valuable insights to weekly interdisciplinary team discussions. Utilize helpful community resources.

Oct 2019 - Aug 2020

Certified Nursing Assistant

Fayetteville, North Carolina Metropolitan Area

Performs basic patient care Observes and reports abnormal occurrences or changes in patient condition. Cleans, stocks, and maintains supplies for the patient and the unit.

Jan 2019 - Sep 2019

Certified Nursing Assistant

Fort Bragg, North Carolina, United States

Prepare patients for various examinations, procedures and medical treatments.Assist hospital staff during patient exams and various procedures.Collect and maintain patient records.Schedule patients for procedures and follow up appointments.

Jun 2019 - Aug 2019

Emergency Room Technician

Burgaw, North Carolina, United States

Phlebotomy procedures Wound Care and Splinting Triage Patient CareCNA Functions

May 2016 - Jan 2019

Certified Nursing Assistant

Wilmington, North Carolina, United States

Competently performs a variety of patient care activities to meet daily personal needs and comfort of the patient. Performs Nurse Aide I skills. Maintains and promotes customer satisfaction. Demonstrates standards of performance: ownership, teamwork, communication and compassion.

Jan 2015 - May 2016
Team & coworkers

Colleagues at SystImmune

Other employees you can reach at systimmune.com. View company contacts for 92 employees →

1 education record

Whitney E. education

  • East Carolina University
    East Carolina University
    Public Health: Community Health
FAQ

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What company does Whitney E. work for?

Whitney E. works for SystImmune.

What is Whitney E.'s role at SystImmune?

Whitney E. is listed as Veeva Vault eTMF and Document Lead at SystImmune.

Where is Whitney E. based?

Whitney E. is based in Raleigh, North Carolina, United States while working with SystImmune.

What companies has Whitney E. worked for?

Whitney E. has worked for Systimmune, Icon Strategic Solutions, Iqvia, Covance, and Landmark Health.

Who are Whitney E.'s colleagues at SystImmune?

Whitney E.'s colleagues at SystImmune include Luke Helgeson, Jinjin Wu, Sishu (Irene) Tong, V. Mitch Luna, and Christine Lee.

How can I contact Whitney E.?

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What schools did Whitney E. attend?

Whitney E. holds Bachelor'S Degree, Public Health: Community Health from East Carolina University.

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