Stephanie Richardson
Clinical Trial Manager, Heart Valves at Artivion, Inc.- Claim this Profile
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Bio
Experience
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Artivion, Inc.
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United States
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Biotechnology Research
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500 - 600 Employee
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Clinical Trial Manager, Heart Valves
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Jun 2022 - Present
Kennesaw, GA
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Aziyo Biologics, Inc.
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United States
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Biotechnology
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1 - 100 Employee
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Associate Director of Clinical Operations
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Dec 2020 - Jun 2022
Woodstock, Georgia, United States
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Clinical Research Manager
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Jan 2019 - Dec 2020
Greater Atlanta Area
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Clinical Research Coordinator
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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.
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Project Administrator
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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
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Clinical Trial Coordinator
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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
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Ryland Homes (now CalAtlantic Homes- Please see updates below)
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United States
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Real Estate
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300 - 400 Employee
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Purchasing Administrator
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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
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University Mechanical & Engineering Contractors, Inc. (CA)
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United States
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Construction
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1 - 100 Employee
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Purchasing Assistant
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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
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Uline
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United States
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Wholesale
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700 & Above Employee
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Administrative Assistant
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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
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Education
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Illinois State University
Bachelor of Science - BS, Business Administration and Management, General