Senior Research Regulatory Coordinator

Job Description:

• Oversee regulatory aspects of clinical research studies taking place in UofL Health facilities and ULP clinics
• Communicate with study teams and ensure regulatory requirements are met before UofL Health Research Office approval
• Work closely with the Clinical Research Review Committee, Interdisciplinary Research Oversight Council, Research Regulatory Coordinator, Human Subjects Protection Program, and External Institutional Review Boards
• Establish standard operating procedures to streamline operations and improve effectiveness and efficiency
• Oversee processes to vet research personnel for access to EMRs and facilities
• Submit IRB applications for UofL Health employed staff and faculty supporting Nursing Excellence initiatives and Pharmacy residency research
• Develop processes and procedures for regulatory oversight
• Review IRB correspondence, determine action items, and document content in the ULHRO system
• Review ULHRO submissions and establish project records and documents for institutional review
• Facilitate the Clinical Research Review Committee process based on operational impact to patient care teams
• Train, assist, and oversee the Research Regulatory Coordinator
• Ensure valid HIPAA authorization for research involving UofL Health patients’ data
• Advise nursing staff on research policies and procedures
• Prepare IRB submissions and maintain regulatory oversight for clinical research projects
• Review completed consent forms for accuracy and compliance
• Review protocols, waivers, consent documents, and data collection sheets for HIPAA authorization alignment
• Maintain compliance with company policies, procedures, and standards of conduct
• Perform other duties as assigned

Requirements:

• Bachelor’s degree (required)
• Experience in clinical research, human subjects’ protection regulations, including HIPAA authorizations, and IRB process (required)
• 5 years of experience in research administration (preferred)
• Professional certification such as CCRP, CHRC, ACRP-CP (preferred)
• Candidate needs to be local to Kentucky
• Compliance with HIPAA privacy and security requirements
• Ability to work first shift (United States of America)