Experience

Saint Louis University

• CTMS Project Analyst

  • Aug 2023 - Present



The University of Kansas Cancer Center

• United States
• Hospitals and Health Care
• 200 - 300 Employee

• Quality Assurance Manager

  • Jan 2023 - Aug 2023

  • Perform internal audits of the KU Cancer Center Oncology trials. • Ensure clinical trial data points entered in Velos system are accurate.• Prepare accrual and safety data for quarterly Data Safety Monitoring Committee meetings

• Sr. Clinical Systems Data Coordinator

  • Jun 2021 - Jan 2023

  • Create eCRFs for in house studies• Prepare accrual and safety data for quarterly Data Safety Monitoring Committee meetings• Produce monthly Accrual Report for leadership• Study Record Completion in Velos CTMS and EDC• Provide data and reports for Cancer Center Support Grant• Ad-hoc CTMS Velos report requests• Redcap CTO Support Requests and CTMS Velos Training/Access Requests• Sharepoint Administrator• Creation of Monthly Accrual Report and Semi-Annual JCERT Report Excel and Powerpoint• Works collaboratively with the Project Management team, IIT Program team, and PRMS Administrator in the coordination and collection of information for cancer clinical trials Show less

• Clinical Data Coordinator

  • Jan 2019 - Jun 2021

  Communicate regarding patient data, status and protocol requirements with research staff.• Conduct clinical trial in accordance with ICH/CFR/GCP and responsible for all data completion; query resolution for assigned protocols.• Assist with the identification and reporting of Adverse and Serious Adverse events in accordance with ICH/CFR/GCP and specific protocols• Responsible for working collaboratively with the Research Nurse Clinician, Clinical Research Coordinator and Clinical Lab Coordinator in the coordination and collection of data for cancer clinical trials.• Responsible for the collection, abstraction, review, documentation, and monitoring of data related to clinical research projects. Show less

• Regulatory Specialist

  • Oct 2018 - Jan 2019

  • Prepare and file all regulatory documents with the local IRB and central IRBs.• Revise Consent Forms as needed per protocol.• Maintain study files according to FDA guidance.• Communicate with study sponsors and CROs regarding regulatory documents and issues.• Provide assistance to study reviewers during monitoring visits and audits.• Assist with study start-up submission process and attend SIV and kick off meetings



American Century Investments

• RPS

  • 1992 - 1999