Senior Clinical Research Regulatory Lead (Remote)

UofL Health; Lexington (KY); Remote; USD 70,000 - 100,000; Full time

Job summary

UofL Health is seeking a Research Regulatory Coordinator Sr to oversee regulatory aspects of clinical studies conducted in UofL Health facilities and clinics. The role collaborates with ULHRO, CRRC, IROC, and nursing/pharmacy research teams to ensure compliance and efficient study start-up.

The position requires a Bachelor’s degree, 5 years of research administration experience, and HIPAA/IRB knowledge. Remote work is possible for local candidates; travel to sites as needed; professional

Qualifications

• Bachelor’s degree required.
• 5 years in research administration preferred; HIPAA and IRB experience required.
• Experience in clinical research and human subjects protection regulations.
• Professional certification such as CCRP, CHRC, or ACRP-CP preferred.

Responsibilities

• Develop processes to streamline regulatory oversight in health facilities and clinics.
• Review IRB correspondence and document actions in ULHRO.
• Prepare IRB submissions and maintain regulatory oversight for nursing and pharmacy research.
• Ensure HIPAA authorizations and data privacy compliance.
• Train and oversee staff vetting for EMR access.
• Ensure HIPAA privacy and security requirements are followed.

Skills

Regulatory oversight

IRB process knowledge

HIPAA compliance

Clinical research coordination

Stakeholder communication

Education

Bachelor’s degree

Tools

EMR access control

IRB submission systems

ULHRO workflow tools

Job description

UofL Health is seeking a Research Regulatory Coordinator Sr to oversee regulatory aspects of clinical studies conducted in UofL Health facilities and clinics. The role collaborates with ULHRO, CRRC, IROC, and nursing/pharmacy research teams to ensure compliance and efficient study start-up.

The position requires a Bachelor’s degree, 5 years of research administration experience, and HIPAA/IRB knowledge. Remote work is possible for local candidates; travel to sites as needed; professional