Remote Senior Research Regulatory Coordinator (KY)

UofL Health; Oklahoma City (OK); Remote; USD 85,000 - 110,000; Full time

Job summary

UofL Health is seeking a remote Research Regulatory Coordinator Sr who can work locally. The role oversees regulatory aspects of clinical studies across ULHRO-approved sites and external IRBs, ensuring compliance before approvals are granted.

Responsibilities include streamlining regulatory processes, vetting research personnel for EMR access, and maintaining HIPAA authorization standards while collaborating with CRRC and IROC to support nursing and pharmacy research initiatives.

Qualifications

• Bachelor’s degree required.
• Experience in clinical research, HIPAA authorizations, and IRB process required.
• 5 years of experience in research administration preferred.
• Professional certifications such as CCRP, CHRC, or ACRP-CP preferred.

Responsibilities

• Develop processes and procedures as needed to streamline regulatory oversight in the UofL Health Facilities and ULP clinics.
• Review all IRB correspondence, determine action items, and document content in ULHRO system to ensure appropriate next steps are completed.
• Review submissions to the ULHRO and establish project records and documents as required for UofL Health Institutional Review.
• Facilitate CRRC process for clinical research based on operational impact to patient care teams to ensure feasibility of projects.
• Train, assist, and oversee the Research Regulatory Coordinator to ensure appropriate vetting for research personnel with access to EMRs & facilities.
• Ensure a valid HIPAA authorization exists for all research involving UofL Health patients’ data.
• Collaborate with IROC to support magnet journey and evidence-based practice by advising nursing staff on policies and procedures for research, prepare IRB submissions and maintain regulatory oversight.
• Review completed consent forms for accuracy and compliance.
• Review IRB documents and data release for medical records data.
• Maintain HIPAA compliance across activities and perform other duties as assigned.

Skills

Regulatory oversight

IRB submissions

HIPAA compliance

Stakeholder training

Education

Bachelor’s degree (required)

Job description

UofL Health is seeking a remote Research Regulatory Coordinator Sr who can work locally. The role oversees regulatory aspects of clinical studies across ULHRO-approved sites and external IRBs, ensuring compliance before approvals are granted.

Responsibilities include streamlining regulatory processes, vetting research personnel for EMR access, and maintaining HIPAA authorization standards while collaborating with CRRC and IROC to support nursing and pharmacy research initiatives.