Senior Research Regulatory Coordinator

🕒 October 12

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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UofL Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Healthcare • Healthcare Insurance • Pharmaceuticals

UofL Health is a fully integrated academic health system focused on delivering patient-centered care. It is a not-for-profit organization with nine hospitals, four medical centers, and over 250 physician practice locations, employing more than 1,200 providers in and around Louisville, Kentucky, including southern Indiana. Affiliated with the University of Louisville School of Medicine, UofL Health emphasizes advanced patient care and participates in clinical trials and research to enhance health outcomes. With a workforce of over 14,000 healthcare professionals, UofL Health aims to transform community health through innovation and compassion.

📋 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)

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