Experience

CTI Clinical Trial and Consulting Services

• United States
• Research Services
• 700 & Above Employee

• Assistant Director, Clinical Project Management

  • Dec 2020 - Present

  Covington, KY

• Sr. Clinical Project Manager

  • Dec 2019 - Dec 2020

• Clinical Project Manager

  • Oct 2014 - Dec 2019

  Covington, KY



Cincinnati Children's

• Hospitals and Health Care
• 700 & Above Employee

• Hematology Regulatory Affairs Specialist

  • Sep 2012 - Oct 2014

  Cincinnati, OH • Act as a liaison between IRB members and researchers to promote information flow and communicate the results of IRB review to investigators and study coordinators in a timely manner. • Prepare electronic IRB submissions to the Cincinnati Children’s Hospital Medical Center IRB (industry and investigator initiated trials); including writing of consent documents, study applications and reports per IRB and other departmental requirements. • Organize and participate in activities to prepare… Show more • Act as a liaison between IRB members and researchers to promote information flow and communicate the results of IRB review to investigators and study coordinators in a timely manner. • Prepare electronic IRB submissions to the Cincinnati Children’s Hospital Medical Center IRB (industry and investigator initiated trials); including writing of consent documents, study applications and reports per IRB and other departmental requirements. • Organize and participate in activities to prepare for audits, quality reviews, and inspections. • Conduct pre-reviews of draft documents and advise investigators and research coordinators regarding potential ethical, regulatory, or content issues before they are submitted for full IRB review. • Maintain essential documents in the Investigator Site Files and work in an “audit ready” manner daily with 25+ studies. Show less



Medpace

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Associate

  • Jul 2008 - Aug 2012

  Cincinnati, OH • Conducted visits at investigative sites around the country including qualification, initiation, routine, and closeout in accordance with ICH-GCP guidelines and per company SOPs. • Demonstrated excellence in time management organization by handling several protocols and sites throughout the country. Therapeutic backgrounds include: endocrinology, hypertension, hypercholesterolemia, and cardiovascular. • Performed 100% source verification by comparing medical history, source documents… Show more • Conducted visits at investigative sites around the country including qualification, initiation, routine, and closeout in accordance with ICH-GCP guidelines and per company SOPs. • Demonstrated excellence in time management organization by handling several protocols and sites throughout the country. Therapeutic backgrounds include: endocrinology, hypertension, hypercholesterolemia, and cardiovascular. • Performed 100% source verification by comparing medical history, source documents and case report forms to ensure all data match. • Verified complete and accurate drug records of receipt, dispensing, and return. • Inspected Investigator Site File for completeness and accuracy while reconciling all essential and regulatory documents. • Composed detailed reports for Clinical Trial Managers and sponsors regarding site performance. • Created a team environment by maintaining excellent relationships with site personnel. • Ensured proper reporting and documenting of adverse events and serious adverse events. Show less



Crestville Drugs

• Pharmacy Technician

  • Apr 1998 - Jul 2008

  Crescent Springs, KY • Filled prescriptions accurately in compliance with state and federal laws using the Renlar and Rx30 computer systems. • Communicated with physician offices to verify prescriptions, refills, and provide information regarding third party billing issues. • Verified patient information by greeting customers at pharmacy counter ensuring accurate, efficient service. • Maintained records for the receipt and dispensing of scheduled II prescriptions. • Performed weekly main pharmacy order… Show more • Filled prescriptions accurately in compliance with state and federal laws using the Renlar and Rx30 computer systems. • Communicated with physician offices to verify prescriptions, refills, and provide information regarding third party billing issues. • Verified patient information by greeting customers at pharmacy counter ensuring accurate, efficient service. • Maintained records for the receipt and dispensing of scheduled II prescriptions. • Performed weekly main pharmacy order for the two major pharmacy vendors. Show less



ViaCord

• Biotechnology Research
• 1 - 100 Employee

• Lab technician

  • May 2005 - Nov 2005

  • Performed hands on cord blood processing according to company SOPs that included receiving, preparation, set-up, triage 1, station 1, station 2, and freezing. • Processed umbilical cord blood by way of RBC depletion and volume reduction and cryogenic froze final product for storage and treatment of disease. • Used aseptic laboratory techniques. • Complied with FDA, CLIA, and AABB regulations. • Maintained the monthly spreadsheet count of cords frozen.