Jane Pritchard Email & Phone Number

United States

South Charleston, West Virginia, United States

Qrtp

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.

Research Triangle Park, Nc

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.

Research Triangle Park, Nc

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

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.

Morrisville, North Carolina

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.

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

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.

Morrisville, North Carolina

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.

Durham, North Carolina

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.

Research Triangle Park,Nc

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.

Durham, North Carolina

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.