Remote Research Regulatory Coordinator (Clinical Trials)

UofL Health; United States; Remote; USD 70,000 - 100,000; Full time

Job summary

UofL Health, a fully integrated regional academic health system, seeks a Research Regulatory Coordinator Sr to oversee regulatory aspects of clinical studies. This remote role requires local residency and interplay with ULHRO, CRRC, IROC, and IRB processes to vet personnel and ensure compliance.

The position involves preparing IRB submissions, maintaining regulatory oversight, and ensuring HIPAA authorization for research involving patient data across UofL Health facilities and clinics.

Qualifications

• Bachelor’s degree (required).
• Experience in clinical research and 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).

Responsibilities

• Develop and streamline regulatory oversight processes for ULHRO in UofL Health facilities and clinics.
• Review IRB correspondence, determine actions, document in ULHRO system.
• Prepare IRB submissions and maintain regulatory oversight for nursing and pharmacy residency research.
• Ensure HIPAA authorization validity for all research involving patient data.
• Collaborate with CRRC, IROC, and IRB bodies to support research governance.

Skills

Regulatory oversight

IRB coordination

HIPAA compliance

Clinical research coordination

Education

Bachelor’s degree

Job description

UofL Health, a fully integrated regional academic health system, seeks a Research Regulatory Coordinator Sr to oversee regulatory aspects of clinical studies. This remote role requires local residency and interplay with ULHRO, CRRC, IROC, and IRB processes to vet personnel and ensure compliance.

The position involves preparing IRB submissions, maintaining regulatory oversight, and ensuring HIPAA authorization for research involving patient data across UofL Health facilities and clinics.