Senior Research Regulatory Coordinator

This is a fully remote position, open to applicants in Kentucky.

📋 Description

• Supervise the regulatory elements of clinical research studies conducted in UofL Health facilities and ULP clinics.

• Liaise with study teams to ensure that all regulatory obligations are fulfilled prior to the approval from the UofL Health Research Office.

• Collaborate closely with the Clinical Research Review Committee, Interdisciplinary Research Oversight Council, Research Regulatory Coordinator, Human Subjects Protection Program, and External Institutional Review Boards.

• Develop standard operating procedures aimed at streamlining operations and enhancing effectiveness and efficiency.

• Oversee the processes for vetting research personnel for access to EMRs and facilities.

• Submit IRB applications for UofL Health employed staff and faculty involved in Nursing Excellence initiatives and Pharmacy residency research.

• Create processes and procedures for regulatory oversight.

• Review IRB communications, identify action items, and document findings in the ULHRO system.

• Assess ULHRO submissions and establish project records and documents for institutional review.

• Facilitate the Clinical Research Review Committee process with consideration of its operational impact on patient care teams.

• Train, assist, and supervise the Research Regulatory Coordinator.

• Ensure valid HIPAA authorization for research involving data from UofL Health patients.

• Provide guidance to nursing staff regarding research policies and procedures.

• Prepare IRB submissions and maintain regulatory oversight for clinical research initiatives.

• Review completed consent forms to ensure accuracy and compliance.

• Evaluate protocols, waivers, consent documents, and data collection sheets for alignment with HIPAA authorization.

• Uphold compliance with organizational policies, procedures, and standards of conduct.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree (mandatory).

• Experience in clinical research, understanding of human subjects’ protection regulations, including HIPAA authorizations, and familiarity with the IRB process (mandatory).

• 5 years of experience in research administration (preferred).

• Professional certification such as CCRP, CHRC, ACRP-CP (preferred).

• Candidates must be local to Kentucky.

• Compliance with HIPAA privacy and security regulations.

• Ability to work first shift (United States of America).

🏝️ Benefits

• Competitive salary.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and growth.

• Engaging work environment.