Remote Senior Research Regulatory Coordinator: IRB & HIPAA

University Medical Center, Inc.; Kentucky; Hybrid; USD 70,000 - 90,000; Full time

Job summary

UofL Health is seeking a Research Regulatory Coordinator Sr to oversee regulatory aspects of clinical studies across facilities and clinics. Remote work is possible, but local presence is required.

You will work with ULHRO, CRRC, IROC, and IRBs to ensure compliance and efficient study activation. Responsibilities include preparing submissions, vetting personnel for EMR access, and maintaining HIPAA compliance for all patient data in research projects.

Qualifications

• Bachelor’s degree required.
• Experience in clinical research and IRB processes.
• Knowledge of HIPAA authorizations.

Responsibilities

• Develop procedures to streamline regulatory oversight in UofL Health facilities and clinics.
• Review IRB correspondence and document actions in ULHRO systems.
• Prepare IRB submissions and maintain regulatory oversight for nursing and pharmacy residency projects.
• Facilitate CRRC processes to ensure feasibility and patient care impact.
• Vet research personnel for access to EMRs and facilities.
• Ensure HIPAA authorization validity for all research involving patient data.

Skills

Regulatory oversight

IRB coordination

HIPAA

Clinical research

Education

Bachelor's degree

Job description

UofL Health is seeking a Research Regulatory Coordinator Sr to oversee regulatory aspects of clinical studies across facilities and clinics. Remote work is possible, but local presence is required.

You will work with ULHRO, CRRC, IROC, and IRBs to ensure compliance and efficient study activation. Responsibilities include preparing submissions, vetting personnel for EMR access, and maintaining HIPAA compliance for all patient data in research projects.