Senior Research Regulatory Coordinator (Remote – KY)

UofL Health; Central City (KY); Remote; USD 65,000 - 90,000; Full time

Job summary

UofL Health is seeking a Research Regulatory Coordinator Sr to oversee regulatory aspects of clinical studies across ULHRO and affiliated clinics. This remote-enabled role requires local presence for occasional site activities and collaboration with study teams to ensure regulatory requirements are met before ULHRO approval.

You will develop SOPs, vet research personnel for EMR access, review IRB submissions, and coordinate with CRRC and IROC, nursing and pharmacy researchers to support Nursing

Qualifications

• Experience in clinical research and regulatory oversight.
• Knowledge of HIPAA protections and IRB processes.
• Experience in human subjects’ protection regulations.

Responsibilities

• Develop regulatory oversight procedures for ULHRO and clinics.
• Review IRB correspondence and document actions in ULHRO system.
• Prepare and submit IRB applications for ULHRO staff and faculty.
• Facilitate CRRC processes to support project feasibility.
• Train and supervise staff in research regulatory procedures.
• Ensure HIPAA authorization validity for research data.
• Maintain compliance with all policies and conduct standards.

Skills

Clinical research

IRB process

HIPAA compliance

Education

Bachelor's degree

CCRP/CHRC/ACRP-CP preferred

Job description

UofL Health is seeking a Research Regulatory Coordinator Sr to oversee regulatory aspects of clinical studies across ULHRO and affiliated clinics. This remote-enabled role requires local presence for occasional site activities and collaboration with study teams to ensure regulatory requirements are met before ULHRO approval.

You will develop SOPs, vet research personnel for EMR access, review IRB submissions, and coordinate with CRRC and IROC, nursing and pharmacy researchers to support Nursing