Executive Assistant Clinical Research

Victoria O’Brien

Manassas, VA ***** - Cell 571-***-****

*******************@*****.***

PROFESSIONAL SUMMARY

I am a project support professional with 20+ years’ experience. I work with various teams to support our clients both internal and external to improve understanding, cooperative resolutions, work-flow redesigns, efficiency, and more. I strive to provide outcomes suitable to those I support professionally and to do so for our external customers/clients in a manner that is discreet. I pay high attention to HIPPA, the HighTech Act, and other government policies that insure confidentiality. I lead, provide guidance, and contribute in all matters required.

HIGHLIGHTS OF QUALIFICATIONS

Substantive knowledge, technical skills, and progressive responsibility include:

MS Office Proficiency

Design & Present monthly webinars

Budget Monitoring/Tracking

Sitecore Proficiency

Support Project Management

ICH-GCP Standards

Freshdesk Proficiency

Support Clinical Research Associates

FDA Regulatory Processes

PubMed Proficiency

Compliance & Regulatory QC

Compliance Procedures

Grammatical and style editing

Sourcing for Presentations & Briefings

Reports & Documentation

Operations & streamlining

Editing Support for Contributing Authors

Clinical Research & Analysis

EDUCATION

Master of Science in Biotechnology, Concentration in Bioscience Regulatory Affairs, The Johns Hopkins University, Kreiger School of Arts and Sciences, Baltimore, MD: expected date of completion: Spring 2019

Bachelor of Science, Biology, University of Mary Washington, Fredericksburg, VA: Graduated 2004

EMPLOYMENT EXPERIENCE

American College of Radiology, Reston, Virginia

Project Coordinator, January 2012 – April 2018

I act to develop and nurture all assigned client accounts from inception to deployment by executing product training, client communications, assist customer migrations, and key client satisfaction requirements.

Receive & triage calls and emails from client participants. Receive, route, track legal documents using SharePoint, EndNote & conversations with attorneys, directors and colleagues

Ensure project documents are complete, current, and stored appropriately and project or job item is up to date with all pertinent project information, communications, and documents

Coordinate, schedule and lead or contribute to all aspects of conference calls and meetings

Manage day-to-day operational aspects of a project

Conduct and lead implementation kick-off calls with clients to outline processes and expectations

Encourage clients to attend online training classes and review recordings where applicable

Develop and conduct product training where online training classes

Maintain in-depth knowledge of our products and up-to-date with ongoing product releases, patches, versioning, upgrade, and migrations

Join IT Task meetings to present cases, propose and implement resolutions

Maintain web content. Create and revise multiple user guides, FAQs, and webinars

Communicate deliverables and timelines regularly to the client

Research and resolve customer concerns, registrations, data discrepancies

Express/American College of Radiology

Temporary Assignment, May – December 2011

As my contract with Express drew to a close, Mr. Lenny Lucy, Esq. believed I would be an excellent member of the American College of Radiology team, and proposed I be hired on fulltime. I began as a fulltime employee January 2012.

Prematics, Inc., McLean, VA

Independent contractor, March 2010 – October 2010

Completed Asset Assurance and Inventory Management

Reviewed site reports, collected field equipment, established, monitored and secured inventory

The monitored and tracked devices through Sales Force Database

Developed guidance documents to deepen internal knowledge and deliver training opportunities to staff

Streamlined device deployments to reduce duplication in the inventory process

Extensive customer/client interaction

Prestwick Pharmaceuticals, Inc., Washington, DC

Clinical Research Specialist, August 2004-February 2008

Reviewed protocols and informed consent forms to ensure compliance with ICH/GCP guidelines, Food and Drug Administration 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 multiple range of Trial Master File documents, electronically and hardcopy

Tracked and archived Chemical, Manufacturing and Control 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

Maintained Table of Changes for IND submissions

Conducted review and crosscheck of case report forms and data management plans

Conducted quality control check of end-of-study database, subject data listings, and clinical study reports to ensure compliance

Performed quality control checks; researched and analyzed source documents and case report forms to extrapolate 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

Eli Lilly & Company, McLean, VA

Administrative Assistant, January 2001- July 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

Planned meetings, events and coordinated logistical arrangements for on- and off-site support

Performed Human Resource activities for monthly recruitment, coordination and execution of orientation and tracked leave policies

Accounted for ‘returned company assets’ during voluntary separations and processed resignation documentation

Received and processed grant and charitable contributions requests in accordance with the company’s Compliance and Regulatory Board policies

Disseminated company Regulatory Board policies ensuring compliance among East Coast Administrative Assistants

EER Systems

Executive Assistant, April 1999- December 2000

Provided support to SES level Executive who served as the Director of the Common Access Card (CAC) program & Executive Office

Developed and maintained executive office library and filing system

Produced communications for program executives

Maintained all calendars, planned and coordinated travel arrangements

Assisted with special projects and provided additional administrative support as required

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