Senior Clinical Research Regulatory Lead (Remote)

UofL Health; Kentucky; Remote; USD 85,000 - 110,000; Full time

Job summary

UofL Health seeks a Research Regulatory Coordinator Sr to oversee regulatory aspects of clinical studies across ULH facilities and ULP clinics. You will ensure regulatory requirements are met before ULHRO approval and work with CRRC, IROC, HIPAA, and external IRBs. The role includes SOP development and staff training to improve efficiency.

The position requires a Bachelor’s degree and strong clinical research experience, with about 5 years in research administration. A CCRP/CHRC is preferred.

Qualifications

• Minimum Bachelor’s degree required.
• Experience in clinical research, human subjects protection and IRB process required.
• About 5 years in research administration preferred.
• Professional certification such as CCRP/CHRC preferred.

Responsibilities

• Develop processes to streamline regulatory oversight in UofL Health facilities.
• Review IRB correspondence and document actions in ULHRO system.
• Review IRB submissions and establish project records for Institutional Review.
• Facilitate CRRC process to assess feasibility and impact on patient care teams.
• Train and oversee personnel vetting for EMR access and facilities.
• Ensure HIPAA authorization exists for research involving patient data.
• Advise nursing and pharmacy residency teams on regulatory policies and procedures.
• Prepare IRB submissions and maintain regulatory oversight for nursing and residency projects.

Skills

IRB process

Regulatory oversight

HIPAA compliance

Clinical research

IRB submissions

Education

Bachelor's degree

Tools

EMR access control

ULHRO system

Job description

UofL Health seeks a Research Regulatory Coordinator Sr to oversee regulatory aspects of clinical studies across ULH facilities and ULP clinics. You will ensure regulatory requirements are met before ULHRO approval and work with CRRC, IROC, HIPAA, and external IRBs. The role includes SOP development and staff training to improve efficiency.

The position requires a Bachelor’s degree and strong clinical research experience, with about 5 years in research administration. A CCRP/CHRC is preferred.