Remote Senior Research Regulatory Coordinator

UofL Health; Kentucky; Remote; USD 75,000 - 110,000; Full time

Benefits offered by this job

Remote work option

Job summary

UofL Health is seeking a remote Research Regulatory Coordinator Sr who will oversee regulatory aspects of clinical studies across UofL Health facilities and clinics. You will work with ULHRO, CRRC, IROC, and IRBs to ensure compliance and efficient operations, guiding SOPs and personnel vetting for EMR access.

The role requires a bachelor’s degree, ~5 years in research administration, and professional certifications are preferred.

Qualifications

• Bachelor's degree is required.
• Experience in clinical research and human subjects’ protections incl. HIPAA authorizations and IRB processes is required.
• Approximately 5 years of experience in research administration is preferred.

Responsibilities

• Develop processes to streamline regulatory oversight in UofL Health facilities and clinics.
• Review IRB correspondence, document action items, and ensure next steps in ULHRO systems.
• Prepare and maintain IRB submissions and regulatory records for nursing and pharmacy research initiatives.
• Facilitate CRRC processes for clinical research based on patient-care impact and feasibility.
• Train and oversee staff to ensure proper vetting for EMR access and facility permissions.
• Ensure HIPAA authorization validity for research involving patient data.
• Support nursing and pharmacy research initiatives through regulatory guidance and policy adherence.

Skills

Regulatory oversight

IRB submissions

HIPAA compliance

Clinical research

Research administration

Education

Bachelor's degree

Job description

UofL Health is seeking a remote Research Regulatory Coordinator Sr who will oversee regulatory aspects of clinical studies across UofL Health facilities and clinics. You will work with ULHRO, CRRC, IROC, and IRBs to ensure compliance and efficient operations, guiding SOPs and personnel vetting for EMR access.

The role requires a bachelor’s degree, ~5 years in research administration, and professional certifications are preferred.