Summary
Overview
Work History
Education
Skills
Timeline
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Victoria O’Brien

Stafford,Virginia

Summary

Having served as a contractor in recent years, my experiences span across diverse fields, collaborating with remarkable individuals. The primary aim is enhancing stakeholder experiences, streamlining workflows, and fostering efficient collaboration among cross-functional teams. Leadership roles in two CT radiation-dose data registries have been undertaken, as well as spearheading client kick-off calls, handling data submission inquiries, assisting in issue resolution, and conducting report reviews. The commitment remains to deliver exceptional support and results with discretion and expertise.

Overview

24
24
years of professional experience

Work History

Personal Assistant to Disabled Individuals

Self-employeed
12.2023 - Current
  • Assisted with feeding and monitored intake to help patients achieve nutritional objectives.
  • Assisted with transferring and positioning clients, ensuring proper body mechanics to reduce the risk of injury for both parties.
  • Improved client comfort by providing exceptional personal care and maintaining a clean, safe environment.
  • Turned and positioned bedbound patients to prevent bedsores and maintain comfort levels.
  • Engaged patients in meaningful conversation, socialization, and activity while providing personal care assistance.
  • Assisted with dressing guidance, grooming, meal preparation, and medication reminders.
  • Implemented physical therapy to support patient improvement in muscle tone, range of motion and injury recovery.
  • Replaced bandages, dressings, and binders to care for wounds and encourage healing.
  • Cooked meals and assisted patients with eating tasks to support healthy nutrition.
  • Entrusted to handle confidential and sensitive situations in professional matter.
  • Built and maintained rapport with clients and family members to facilitate trusting caregiver relationship.
  • Supported daily hygiene needs of patients by assisting with bathing, dressing, dental care and personal grooming.

Sr. Project Coordinator

Medtronic
08.2022 - 04.2023
  • Heavy use of Service Now LMS for created & published knowledge management articles
  • Created new articles within approved style guide templates and formats
  • Close communication with author(s) and LMS final-approval processor during article updates
  • Heavy use of SharePoint to create departmental intranet pages
  • Managed departmental wikis
  • Facilitated document migration
  • Assigned and tracked end-user access requests for in-house and contractor-maintained databases

Sr. Project Coordinator

Insight Enterprise
06.2021 - 08.2022
  • Provided support to multiple project managers
  • Responsible for scheduling and logistically coordinating site visits
  • Created and led kick-off calls with clients and internal stakeholders
  • Managed consumption of personnel hours and budgetary project forecasting
  • Developed and monitored contract change requests through the approval process
  • Created and maintained spreadsheets and databases for tracking and reporting purposes
  • Frequent use of Smart Sheets and Excel trackers
  • Recorded meeting minutes, log risks, recorded black-listed field contractors
  • Use of SAP for end-user updates and report generation

Project Coordinator

I-ACT for Children
01.2019 - 04.2021
  • Provided support to Sr. Project Manager and COO
  • Customized CRM Salesforce application to serve as project management tools and archival space for site initiation questionnaires
  • Maintained Redcap as the System Administrator as well as the development of site interest, early engagement, and feasibility questionnaires
  • Developed detailed reports, flow charts, Ghant charts for Site Identification department
  • Conducted User Acceptance Training (UAT) for internal cross-functional teams involved in the design process
  • Maintained Talent LMS documents, developed related test questions, and tracked employee completion
  • Conducted TSheets bi-weekly reviews to correct budget coding
  • Maintained member portal web content via WordPress software
  • Interviewed operational candidates, provided training and ongoing guidance/best practice sharing
  • Provided status updates to stakeholders and participated in project meetings
  • Produced meeting minutes and agendas as needed
  • Created a structure of project documentation on shared site using SharePoint and Box
  • Designed complex, multiple online surveys / questionnaires using WordPress publication tool

Project Coordinator

Allstate Insurance
06.2018 - 12.2018
  • Monitored and shepherded policy applications toward issuance
  • Developed weekly reports, provided timelines, risk management, Gantt charts
  • Collaborated with field agents and financial staff regarding high-priority items
  • Streamlined workflow to maximize number of applications for daily, weekly, and monthly review

Project Coordinator

American College of Radiology
05.2012 - 04.2018
  • Led kick-off calls with new radiology clients to outline processes and expectations
  • Developed and conducted personal data registry training when online training classes are limited
  • Coordinated, scheduled and led all aspects of introductory & quarterly report webinars
  • Responded to impromptu client calls and emails
  • Researched and resolved customer concerns, registrations, data discrepancies
  • Assisted our clients with data migrations, new product releases, patches, versioning, and upgrades
  • Joined IT Task meetings to present cases, propose and implement resolutions
  • Maintained web content with updated user guides, data dictionary, FAQs, and pre-recorded webinars
  • Received, routed, tracked legal documents using SharePoint
  • Use of SAP for end-user updates and report generation
  • Provided guidance regarding the 2008 MIPPA/CMS law and regulatory criteria pertaining to client site reimbursements
  • Monitored an outcomes list, worked with client sites to complete applications & submit images before EOY deadline
  • Maintained client contact call lists
  • Responsible to engage 1,300 client sites to re-accredit before January 1, 2012

Contractor

Prematics, Inc.
03.2010 - 10.2010
  • Completed Asset Assurance and Inventory Management
  • Reviewed site reports, collected field equipment, established, monitored and secured inventory
  • Monitored and tracked devices through Salesforce Database
  • Developed guidance documents to deepen internal knowledge and deliver training opportunities to staff
  • Streamlined device deployments to reduce duplication in the inventory process
  • Had extensive customer interactions

Clinical Research Specialist

Prestwick Pharmaceuticals, Inc.
08.2004 - 02.2008
  • Reviewed protocols and informed consent forms to ensure compliance with ICH/GCP guidelines, FDA Code of Federal Regulations, and company SOPs
  • Tracked monitoring plans and reports for site initiation, monitoring, and closeout visits developed by Sponsor Representative or CRO
  • Tracked, stored, archived in accord with ISO 90001 compliance:
  • Trial Master File documents electronically (dedicated server and file folders) and hardcopy (dedicated fire and water destruction prevention)
  • Created and maintained a document repository for active drug development projects and archiving legacy documents
  • Tracked and archived CMC documents, ie. stability testing, validation studies, for both Drug Substance and Drug Products
  • Coordinated and managed study documents, regulatory documents, and references for multiple consultants and internal staff for eCTD, IND, ISS, and NDA submissions
  • Heavy use of EndNote (a citation and reference management tool)
  • Reviewed, edited contributing authors’ regulatory submissions to comply with style guide. Routed to PM, CMO, or regulatory VP as appropriate
  • Performed quality control checks:
  • Provided proofreading, style consistency, format compliance with FDA submission requirements, created Table of Changes as well as Table of Contents, Footnotes, Tables, Appendices
  • Conducted review and crosscheck of case report forms and data management plans
  • Conducted quality control check of end-of-study database, subject data listing, and clinical study reports
  • Compared source documents and case report forms to pull safety data, summarize, and present findings
  • Reviewed contracts to ensure appropriate study activities per protocol
  • Assisted in regulatory and logistics activities related to clinical supplies packaging and tracking
  • Assisted Principal Investigators’ meeting on-site, gathered legacy documents ahead of time, and contacted attendees to retrieve

Administrative Assistant

Eli Lilly & Company
01.2001 - 07.2004
  • Responsible for overall office management
  • Supported requirements to four sales districts including managers, Program Specialists, an HR Recruitment Associate, and a Regional Sales Director
  • Maintained and monitored monthly budget tracking for four $1.5M budgets at district and sales levels
  • Scheduled meetings, events and coordinated logistical arrangements for on and off-site support
  • Performed HR activities for monthly recruitment, coordination, and execution of orientation
  • Supported hiring and on-boarding process for new employees
  • Accounted for ‘returned company assets’ during voluntary separations and processed resignation documentation
  • Received and processed grant and charitable contributions requests
  • Disseminated company Regulatory Board policies ensuring compliance among East Coast Administrative Assistant

Education

Bachelor of Science - Biology

University of Mary Washington
Fredericksburg, VA

Skills

    Substantive knowledge, technical skills, and progressive responsibilities include:

  • Advanced use of Word
  • Advanced Excel
  • Time management
  • Multitasking and organization
  • Customer service
  • Data Registry Coordination
  • Document Management
  • Management Teams
  • Design & Present monthly webinars
  • Track, report project details, & progress
  • Salesforce Admin proficiency
  • Redcap Admin experience
  • Heavy use of EndNote
  • Heavy use of SharePoint
  • Freshdesk proficiency
  • Create User Guides, Code Books, Data Dictionaries
  • Support to Contributing Authors
  • Administrative support
  • Resourceful
  • Organizing and preparing meetings
  • Client relations
  • Project coordination
  • Advanced computer skills

Timeline

Personal Assistant to Disabled Individuals

Self-employeed
12.2023 - Current

Sr. Project Coordinator

Medtronic
08.2022 - 04.2023

Sr. Project Coordinator

Insight Enterprise
06.2021 - 08.2022

Project Coordinator

I-ACT for Children
01.2019 - 04.2021

Project Coordinator

Allstate Insurance
06.2018 - 12.2018

Project Coordinator

American College of Radiology
05.2012 - 04.2018

Contractor

Prematics, Inc.
03.2010 - 10.2010

Clinical Research Specialist

Prestwick Pharmaceuticals, Inc.
08.2004 - 02.2008

Administrative Assistant

Eli Lilly & Company
01.2001 - 07.2004

Bachelor of Science - Biology

University of Mary Washington

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Victoria O’Brien