Experience

Clark Regional Medical Center

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Circulating Nurse

  • May 2021 - Present



Baptist Health Lexington

• United States
• Medical Practices
• 400 - 500 Employee

• Research Regulatory Specialist/ CTMS System Administrator

  • Oct 2003 - Aug 2021

  • Direct the preparation and submission of regulatory applications, reports, or correspondence• Provide regulatory guidance to research department for new and existing clinical trials• Develop regulatory strategies and implementation plans for the preparation and submission of new clinical trial applications to the Institutional Review Board• Implement or monitor complaint processing systems to make sure effective timely resolution of sponsor monitoring visits• Maintain current knowledge of relevant regulations, including CFR guidelines• Manage activities such as audits and regulatory agency inspections• Monitor emerging trends regarding industry regulations to define potential impacts on organizational processes• Participate in the implementation of clinical trial protocols• Serves as a communication liaison to regulatory agencies • Represent organizations before regulatory agencies during audits• Contribute to the development or implementation of business unit strategic operating plans• Coordinate internal audit findings and corrective actions• Develop maintain standard policies and local working practices• Evaluate new software systems as related to electronic submissions• Evaluate regulatory affairs aspects that are specifically green, green policy implementation• Monitor regulatory affairs activities to make sure that they are aligned with corporate sustainability or green initiatives• Document control and retention specials for all clinical trials• Preceptor for new research staff and volunteers• Work with the Director of Research of evaluation of potential new employees• Assist with implementation of CTMS system (MERGE) and IRB submission system (iMeDRIS)• Facilitates training on staff for CTMS system (MERGE) and IRB submission system (iMeDRIS)• Analyzes workflow in order to maximize CTMS system (MERGE) capabilities• Develop protocols, policies and procedures relating to CTMS System (MERGE) Show less

• Research Regulatory Specialist/ CTMS Administrator

  • Oct 2003 - Aug 2021