Experience

Advanced Clinical

• United States
• Biotechnology Research
• 700 & Above Employee

• GRA Planning Group Specialist

  • Feb 2018 - Present

  CSL Behring Planning Group Specialist CSL Behring Planning Group Specialist



inVentiv Health Clinical

• United States
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Senior Clinical Trial/Administrative Assistant, Clinical Monitoring

  • 2013 - 2017

  Provide administrative support to US and Canada (CA) Clinical Monitoring (CM) teams. To include confidential support to Department Executive Director and Management. ~ Provided project management: running monthly management reports, CM SharePoint creation and maintaning, vendor management and supply approvals of homebased offices, etc.;~ Generate, maintain, and distribute CM reports to management;~ Assist with the Clinical Operation responsibilities of tables and listings review;~ Biweekly orientation with new CM hires on home-based request processes;~ Trained Administrative Assistants on job functions;~ Processed, through Coupa, study related supplies utilitized by Clinical Monitoring team to included over 400 CRAs and Clinical Project Leads, acrossed the US. Show less

• Senior Technical Assistant, PharmaNet/i3 (now inVentivHealth)

  • 2005 - 2013

  ~ Review expense reports (ER) for North American (NA) regional staff;~ Orientation training of new CRAs via WebEx on ER processes; ~ Prepare and update PowerPoint presentations for training of clinical monitors;~ Provided monthly or bi-monthly orientation sessions with new CRAs~ Processing and uploading medical documents to eTMF system; ~ Set-up and maintain project and site files; ~ Fax, photocopy, and distribute study-related documents; ~ Generate and maintain study-specific tracking spreadsheets; ~ Train Technical Assistants on job functions Show less



US Restaurants, Inc

• Blue Bell, PA, USA

• Payroll & Accounting Associate

  • 2002 - 2004

  ~ Responsible for calculating, printing, and shipping payroll for US employees; ~ Ran reports for taxes, benefits, and wage attachments; ~ Responsible for filing, printing, and sending annual W-2s, Social Security verification of new hires, and other accounting duties; ~ Set up new hire files and accounting profiles ~ Responsible for calculating, printing, and shipping payroll for US employees; ~ Ran reports for taxes, benefits, and wage attachments; ~ Responsible for filing, printing, and sending annual W-2s, Social Security verification of new hires, and other accounting duties; ~ Set up new hire files and accounting profiles



ICON plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Document Control Associate, Quality Assurance

  • 2000 - 2001

  ~ Coordinated and managed local and global departmental procedures ~ Organized and maintained a process for creating, approving, and maintaining and archiving internal procedures in a manner consistent with ICON/GCP requirements~ Ran test scripts for a new document control system (QUMAS) and upgrades~ Trained new hires on procedures through QUMAS~ Distributed hard and electronic copies of procedures to US offices~ Updated and maintained database for tracking procedure training required by staff~ Created all new ICON procedural forms as Word fill in templates~ Assisted QA group with audit preparations Show less

• Regulatory Affairs Document Coordinator

  • 1996 - 2000

  ~ Responsible for formatting clinical study reports, and creating mock SAS tables and listings for clients using MS Word ~ Wrote macros used to format narratives, and supervised and tracked progress of narratives~ PDF conversion of reports submitted to the FDA~ Created Word fill in template for FDA 1571 submissions~ Responsible for word processing, document compilation, and performing Quality Control (QC) on regulatory documents sent to clients

• Administrative Assistant, Quality Assurance

  • 1996 - 1997

  ~ Responsible for converting forms from Word Perfect to MS Word~ Recreated forms as templates that were password protected~ Created and maintained database for tracking of procedure training required by staff~ Distributed hard and electronic copies of procedures to US offices