Senior Clinical Research Regulatory Coordinator (Remote KY)

UofL Health; New York (NY); Remote; USD 70,000 - 110,000; Full time

Job summary

UofL Health remote role requires overseeing regulatory aspects of clinical studies across facilities and clinics. You will coordinate with ULHRO, CRRC, IROC, and IRBs to ensure compliance and timely approvals. The role includes establishing SOPs and vetting personnel with EMR access.

The candidate will prepare IRB submissions, maintain regulatory records, and support Nursing Excellence initiatives and Pharmacy residency research. A Bachelor’s degree and IRB experience are essential.

Qualifications

• Bachelor’s degree required.
• Experience in clinical research and IRB processes.
• HIPAA authorizations knowledge is required.
• 5 years in research administration preferred.

Responsibilities

• Develop regulatory oversight processes for ULH facilities and clinics.
• Review IRB correspondence and document next steps in ULHRO systems.
• Prepare and maintain IRB submissions and project records.
• Ensure HIPAA authorizations exist for research data.
• Train staff on regulatory compliance and vet research personnel.

Skills

Regulatory oversight

IRB submissions

HIPAA compliance

Research administration

Education

Bachelor’s degree

Tools

IRB portal

Job description

UofL Health remote role requires overseeing regulatory aspects of clinical studies across facilities and clinics. You will coordinate with ULHRO, CRRC, IROC, and IRBs to ensure compliance and timely approvals. The role includes establishing SOPs and vetting personnel with EMR access.

The candidate will prepare IRB submissions, maintain regulatory records, and support Nursing Excellence initiatives and Pharmacy residency research. A Bachelor’s degree and IRB experience are essential.