Remote Research Regulatory Lead for Clinical Trials

UofL Health

New York (NY)

Hybrid

USD 90,000 - 110,000

Full time

7 days ago

Be an early applicant

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

UofL Health is seeking a Research Regulatory Coordinator Sr to oversee regulatory aspects of clinical studies conducted in UofL Health facilities and clinics. This remote-friendly role requires local presence for occasional on-site work and coordination with ULHRO, CRRC, IROC, and IRB processes.

You will implement SOPs, vet research personnel for EMR access, and ensure HIPAA compliance across projects. Responsibilities include managing IRB submissions, maintaining project records, guiding the

Qualifications

Bachelor’s degree required.
Experience in clinical research and HIPAA authorizations.
IRB process experience required.
5 years of experience in research administration preferred.

Responsibilities

Develop processes to streamline regulatory oversight in UofL Health facilities and clinics.
Review IRB correspondence and document actions in ULHRO systems.
Establish project records for UofL Health Institutional Review.
Coordinate CRRC processes to assess feasibility and impact on patient care teams.
Train and oversee staff for vetting research personnel with EMR access and HIPAA compliance.
Ensure HIPAA authorization exists for all patient data used in research.