[Hiring] Senior Research Regulatory Coordinator @UofL Health

Role Description

The Research Regulatory Coordinator Sr position is responsible for overseeing the regulatory aspects of clinical research studies taking place in UofL Health facilities and ULP clinics. The position communicates with the study team for each project and ensures regulatory requirements are met before the UofL Health Research Office (ULHRO) approval is granted. The position works closely with:

• UofL Health Clinical Research Review Committee (CRRC)
• Interdisciplinary Research Oversight Council (IROC)
• Research Regulatory Coordinator
• UofL Human Subjects Protection Program
• External Institutional Review Boards (IRB)

The Research Regulatory Coordinator Sr establishes standard operating procedures as needed to streamline operations and increase effectiveness and efficiency with the ULHRO team members and service line leaders. The position oversees processes to vet Research Personnel for access to EMRs and facilities and submits IRB applications for UofL Health employed staff and faculty to support Nursing Excellence initiatives and Pharmacy residency research.

Essential Functions

• Develop processes and procedures as needed to streamline regulatory oversight in the UofL Health Facilities and ULP clinics.
• Review all IRB correspondence, determine action items, and document content in ULHRO system to ensure appropriate next steps are completed.
• Review submissions to the ULHRO and establish the project records and documents as required for UofL Health Institutional Review.
• Facilitate the Clinical Research Review Committee (CRRC) process for clinical research based on the operational impact to patient care teams to ensure feasibility of projects.
• Train, assist, and oversee the Research Regulatory Coordinator as needed to ensure appropriate vetting for research personnel who need access to our EMRs & facilities.
• Ensure a valid HIPAA authorization exists for all research involving UofL Health patients’ data.
• Work closely with the Interdisciplinary Research Oversight Council to support the magnet journey and evidence-based practice by advising nursing staff on policies and procedures for research.
• Prepare IRB submissions and maintain regulatory oversight for clinical research projects for UofL Health Nursing staff and Pharmacy residency as needed.

Other Functions

• Review completed consent forms for accuracy and compliance.
• Review documents included in IRB submissions and IRB correspondence regarding collection and release of UofL Health medical records data, including reviewing protocols, waivers, consent documents, and data collection sheets to determine if any changes are needed for HIPAA authorization to be congruent with protocol.
• Maintain compliance with all company policies, procedures, and standards of conduct.
• Comply with HIPAA privacy and security requirements to maintain confidentiality at all times.
• Perform other duties as assigned.

Qualifications

• 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)