Jane Pritchard

Experience

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  Duke University Health System

  Mar 1985 - Jul 1990

  Senior Research Technician

  Performed ongoing experiments to investigate the mechanisms for the induction of anti-DNA and other auto-antibodies using animal models and in patients with systemic lupus erythematosus and rheumatoid arthritis under the direction of Duke MD, PhD. Trained Duke Rheumatology fellows and Duke medical students on a variety of laboratory techniques.

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  Burroughs Wellcome Company

  Jul 1990 - Jul 1995

  Junior Research Pharmacologist

  Performed concentration-response studies on isolated, electrically stimulated, rat cardiac muscle. Conducted receptor binding studies to screen pharmaceutical compounds in cardiovascular drug discovery program. Developed immunoassays to a variety of proteins of interest and performed a variety of other standard laboratory techniques.

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  Duke University Medical Center

  Apr 1997 - May 1999

  Administrative Coordinator

  Fiscal management under the direction of the Principal Investigator for 15-20 concurrent clinical studies for a clinical trials unit with 6 employees. Responsible for the submission of all relevant study documents to the Duke IRB, maintenance of study regulatory files, preparation for an FDA audit, and submission of all study contracts to the university grants and contracts office. Coordinated the hiring of clinical staff.

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  PharmaResearch Corporation - Morrisville, NC USA

  Jan 1999 - Jan 2003

  Assistant Project Manager

  Monitored and provided site management for 16 investigative sites on two concurrent HIV studies. Mentored CRA trainees including sign-off on accompanied site visits.

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  PharmaResearch Corp.

  May 1999 - Aug 2002

  Monitored and provided site management for 16 investigative sites on two concurrent HIV studies. Provided in house site management support to regionally based monitors. Mentored CRA trainees including competency sign-off to complete independent monitoring visits. Led US site identification efforts for phase III study in antiretroviral Naive HIV subjects. Performed pre-study, selection, initiation, interim, and close-out monitoring visits to assigned sites. Assisted with the resolution of data queries on separate HIV studies during interim analysis and database lock.

  • Senior Clinical Research Associate

    Aug 2001 - Aug 2002

  • Clinical Research Associate

    May 1999 - Aug 2001
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  Charles River/Inveresk

  Jan 2003 - Jan 2004

  Assistant Project Manager

  Maintained global tracking tool for quarterly DEXA scans for all study subjects and was CRO point of contact to troubleshoot issues with DEXA vendor and sites. Led close-out efforts for final TMF review during HIV study close-out and packaging/shipment of TMF to the sponsor. Completed site close-out visits at assigned sites.

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  Inveresk

  Jun 2004 - Sept 2004

  Project Manager

  Project manager on Hepatitis C clinical trial during study start-up. Negotiation of study budget. Developed study projections, project plans, and status reports for the sponsor.

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  Trio Clinical Research contracting with GlaxoSmithine

  Sept 2004 - Mar 2006

  Clinical Research Scientist

  Outsourced, managed, and oversaw Phase I infectious disease/antiviral clinical trials. Supervised clinical monitoring activities. Coordinating author on two Phase I protocols.

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  Quintiles, Inc..

  Apr 2006 - Jan 2009

  Project Manager

  Project manager for two rheumatoid arthritis studies - one US only, one global. Managed input from the following service lines: feasibility, site identification, site start-up, clinical monitoring, regulatory affairs, pharmacovigilance, data management, and biostatistics.Participated in two bid defenses and collaborated with the business development team in creating business proposals.

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  IQVIA/ QuintilesIMS/ Quintiles, Inc.

  Nov 2009 - May 2018

  Associate Clinical Project Manager

  North American (NA) Clinical Project Manager on global ulcerative colitis/Crohn's megatrial during study close-out and database lock. Oversight of NA Clinical Research Associate team. Provided audit responses in collaboration with quality assurance contact. Authorized investigator payments. Oversight of Clinical Team Assistant’s review of regulatory files (TMF).Unblinded Clinical Project Manager for two global lupus nephritis studies with oversight of 28 unblinded Clinical Research Associates. Contributing author of unblinded team operational plans. Responsible for all unblinded team training.Oversight of site identification and site selection for US study including SWAT CRA assignments and trip report review. Show less

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  Personal - Family Member Care

  May 2018 - Jan 2020

  Caregiver
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  West Virginia Department of Health and Human Resources

  Oct 2020 - Sept 2022

  Laboratory Scientist 1
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  WEST VIRGINIA UNIVERSITY RESEARCH CORPORATION

  Oct 2022 - Oct 2023

  Grants Accountant
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  West Virginia Clinical and Translational Science Institute

  Oct 2022 - now

  Senior Grants Accountant