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UofL Health
UofL Health
Sponzor vizuma H1BFarmacevtski izdelkiZdravstveno varstvoZdravstveno zavarovanje
UofL Health is a not-for-profit academic health system serving Louisville, Kentucky, and southern Indiana. Its network includes nine hospitals, four medical centers and more than 250 physician practice locations, supported by over 1,200 providers and a workforce of more than 14,000 healthcare professionals. Affiliated with the University of Louisville School of Medicine, the system provides patient-centered care and conducts clinical trials and research to advance health outcomes. Its hiring spans a large regional healthcare network.
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Delovna mesta v podjetju

Senior Research Regulatory Coordinator (Remote, Kentucky)

Oversee IRB, HIPAA, and clinical research compliance across UofL Health facilities and clinics. Support research teams, nursing initiatives, and pharmacy residency projects.

USZdružene države AmerikeKYKentuckyNa daljavoPolni delovni časSeniorZahtevani Jezik: angleščinaSkladnost

Opis

  • Oversee regulatory compliance for clinical research at UofL Health facilities and ULP clinics.
  • Coordinate with study teams to meet regulatory requirements before UofL Health Research Office approval.
  • Collaborate with research review and oversight committees, the Human Subjects Protection Program, the Research Regulatory Coordinator, and external IRBs.
  • Create standard operating procedures to make research operations more effective and efficient.
  • Manage processes for approving research personnel’s access to electronic medical records and facilities.
  • Submit IRB applications for UofL Health staff and faculty involved in Nursing Excellence initiatives and pharmacy residency research.
  • Develop procedures for regulatory oversight.
  • Review IRB correspondence, identify required actions, and record details in the ULHRO system.
  • Review ULHRO submissions and prepare project records and documents for institutional review.
  • Coordinate Clinical Research Review Committee reviews with consideration for their operational impact on patient care teams.
  • Train and support the Research Regulatory Coordinator and oversee their work.
  • Confirm valid HIPAA authorization for research using UofL Health patient data.
  • Guide nursing staff on research policies and procedures.
  • Prepare IRB submissions and oversee regulatory compliance for clinical research projects.
  • Check completed consent forms for accuracy and compliance.
  • Review protocols, waivers, consent documents, and data collection sheets for alignment with HIPAA authorization.
  • Follow company policies, procedures, and standards of conduct.
  • Carry out other assigned duties.

Zahteve

  • Bachelor’s degree required.
  • Experience in clinical research, human subjects protection regulations including HIPAA authorizations, and IRB processes required.
  • Five years of research administration experience preferred.
  • Professional certification such as CCRP, CHRC, or ACRP-CP preferred.
  • Must be based in Kentucky.
  • Must comply with HIPAA privacy and security requirements.
  • Must be available to work first shift in the United States.

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