Stephanie Richardson

Clinical Trial Manager, Heart Valves at Artivion, Inc.
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Woodstock, Georgia, United States, GE

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

You need to have a working account to view this content.
You need to have a working account to view this content.

Experience

    • United States
    • Biotechnology Research
    • 500 - 600 Employee
    • Clinical Trial Manager, Heart Valves
      • Jun 2022 - Present

      Kennesaw, GA

    • United States
    • Biotechnology
    • 1 - 100 Employee
    • Associate Director of Clinical Operations
      • Dec 2020 - Jun 2022

      Woodstock, Georgia, United States

    • Clinical Research Manager
      • Jan 2019 - Dec 2020

      Greater Atlanta Area

    • Clinical Research Coordinator
      • Jun 2017 - Jan 2019

      Roswell, GA • Execution and oversite of clinical research studies. • Responsible for assisting with the development of clinical studies, handling all aspects of clinical site initiation, maintenance, and collection of high quality and well-managed clinical data to support development and marketing efforts. • Compile regulatory submission documentation and maintain organized regulatory and clinical files. • Assist with clinical study protocol development, clinical site selection and training… Show more • Execution and oversite of clinical research studies. • Responsible for assisting with the development of clinical studies, handling all aspects of clinical site initiation, maintenance, and collection of high quality and well-managed clinical data to support development and marketing efforts. • Compile regulatory submission documentation and maintain organized regulatory and clinical files. • Assist with clinical study protocol development, clinical site selection and training, data collection, data analysis, and study report development. • Perform clinical data monitoring activities to ensure all data collected is accurate and complete. • Maintain clinical databases/systems, and other ad hoc tasks associated with clinical research as required.

    • Project Administrator
      • Oct 2013 - Jun 2017

      Roswell, GA • Responsible for administrative and project related duties supporting several executives, clinical studies, and quality. • Answer the phone, schedule conference calls, expense reports, organize on-site and off-site meetings, and make travel arrangements. • Case report form and regulatory binder assembly and maintenance for clinical studies. • Product regulatory releases. • R&D material organization and management. • Apostilles and authentications for OUS product… Show more • Responsible for administrative and project related duties supporting several executives, clinical studies, and quality. • Answer the phone, schedule conference calls, expense reports, organize on-site and off-site meetings, and make travel arrangements. • Case report form and regulatory binder assembly and maintenance for clinical studies. • Product regulatory releases. • R&D material organization and management. • Apostilles and authentications for OUS product registration • Clinical site payments and invoices for pre- and post-market studies. • Maintain and update organizational charts. • Organize and log implant cards received via mail. • Organization of FDA correspondence. • Management of TYKE training documentation, certificates, and shipping authorizations. • Order Certificates to Foreign Government Show less

    • Clinical Trial Coordinator
      • Apr 2008 - Sep 2013

      Duluth, GA • Responsible for administrative and project related duties supporting several managers for multiple medical device companies. • Answer the phone, schedule conference calls, organize off-site meetings, make travel arrangements, distribute mail, and serve as a back-up for office operations. • Maintain Document Control logs, indexes, hard copy files, and electronic files. • Inventory control and tracking of clinical equipment and supplies. • Shipment and tracking of investigational… Show more • Responsible for administrative and project related duties supporting several managers for multiple medical device companies. • Answer the phone, schedule conference calls, organize off-site meetings, make travel arrangements, distribute mail, and serve as a back-up for office operations. • Maintain Document Control logs, indexes, hard copy files, and electronic files. • Inventory control and tracking of clinical equipment and supplies. • Shipment and tracking of investigational devices, sometimes using cold chain shipping. • Purchasing and shipping of clinical supplies in compliance with Quality System. • Help maintain Clinical Site Regulatory binders. • Develop, update, and prepare case report forms, protocols and other study documents. • Site payments, Medical Advisory Board payments, and properly code invoices. • Data management. • Origination, processing, and maintenance of contractual agreements. • Traveled throughout the U.S. and Europe to be present for site initiation, study procedures, and for monitoring. • Worked with contract research organizations (CROs) for European clinical sites. Show less

    • United States
    • Real Estate
    • 300 - 400 Employee
    • Purchasing Administrator
      • Apr 2005 - Jan 2008

      Roswell, GA • Responsible for processing invoices for five estimators. • Generated material orders for extra material from the field. • Analyzed and adjusted cost code changes on the open commitments and budget. • Managed and maintained options cost and availability data. • Created and processed purchase orders and custom options for houses at time of start. • Keyed work orders and change orders. • Generated monthly reports for houses closed. • Researched option profitability. •… Show more • Responsible for processing invoices for five estimators. • Generated material orders for extra material from the field. • Analyzed and adjusted cost code changes on the open commitments and budget. • Managed and maintained options cost and availability data. • Created and processed purchase orders and custom options for houses at time of start. • Keyed work orders and change orders. • Generated monthly reports for houses closed. • Researched option profitability. • Added or expired options, standard features, county requirements, and area figures. • Revised cost of options. • Entered plan budgets and cost for new plans. • Entered options for new communities. • Back up person for insurance compliance of vendors and front desk duties. Show less

    • United States
    • Construction
    • 1 - 100 Employee
    • Purchasing Assistant
      • Jun 2002 - Aug 2004

      El Cajon, CA • Successfully assumed duties of Assistant Purchasing Manager when necessary. • Managed costing of fuel expenditures. • Processed invoices, purchase orders, and material requisitions. • Reviewed pricing and accuracy of quotes from vendors. • Organized, generated orders, and maintained office supply inventory for administrative offices. • Arranged for express shipping needs. • Organized and maintained submittal binders. • Monitored and maintained office equipment. •… Show more • Successfully assumed duties of Assistant Purchasing Manager when necessary. • Managed costing of fuel expenditures. • Processed invoices, purchase orders, and material requisitions. • Reviewed pricing and accuracy of quotes from vendors. • Organized, generated orders, and maintained office supply inventory for administrative offices. • Arranged for express shipping needs. • Organized and maintained submittal binders. • Monitored and maintained office equipment. • Developed a spreadsheet tracking lead-time requirements for material requisitions. • Established cost savings by regularly detecting pricing errors. • Developed and nurtured a good relationship with vendors. • Front desk receptionist, distributed mail, ordered lunch for meetings. Show less

    • United States
    • Wholesale
    • 700 & Above Employee
    • Administrative Assistant
      • Jul 2000 - Mar 2002

      Waukegan, IL • Obtained quotes from vendors and arranged contractual services such as landscaping and snow removal. • Organized, generated orders, and maintained company-wide office supply inventory. • Electronically processed inventory, price and vendor changes, minimum and maximum order points, and apprised vendors of ship-date schedule changes. • Researched and resolved invoices with price or quantity discrepancies. • Coordinated monthly employee random drug-testing process. • Responsible… Show more • Obtained quotes from vendors and arranged contractual services such as landscaping and snow removal. • Organized, generated orders, and maintained company-wide office supply inventory. • Electronically processed inventory, price and vendor changes, minimum and maximum order points, and apprised vendors of ship-date schedule changes. • Researched and resolved invoices with price or quantity discrepancies. • Coordinated monthly employee random drug-testing process. • Responsible for tracking receivables for three local warehouses and matching receivables with purchase orders. • Organized and maintained receiving documents for seven nationwide company branches. • Generated discrepancy, return, damaged/defective product, and backorder reports. • Coordinated dock appointments for incoming shipments. • Successfully cross-trained in several departments. • Entrusted with confidential employment records. • Developed excellent inter-office communication skills. • Handled travel arrangements for flights, limo service, car rentals, and hotels. Show less

Education

  • Illinois State University
    Bachelor of Science - BS, Business Administration and Management, General
    1996 - 2000

Community

You need to have a working account to view this content. Click here to join now