Senior Research Regulatory Coordinator, Remote

UofL Health; New York (NY); À distance; USD 70 000 - 110 000; Plein temps

Résumé du poste

UofL Health remote role requires overseeing regulatory aspects of clinical studies across facilities and clinics. You will coordinate with ULHRO, CRRC, IROC, and IRBs to ensure compliance and timely approvals. The role includes establishing SOPs and vetting personnel with EMR access.

The candidate will prepare IRB submissions, maintain regulatory records, and support Nursing Excellence initiatives and Pharmacy residency research. A Bachelor’s degree and IRB experience are essential.

Qualifications

• Bachelor’s degree required.
• Experience in clinical research and IRB processes.
• HIPAA authorizations knowledge is required.
• 5 years in research administration preferred.

Responsabilités

• Develop regulatory oversight processes for ULH facilities and clinics.
• Review IRB correspondence and document next steps in ULHRO systems.
• Prepare and maintain IRB submissions and project records.
• Ensure HIPAA authorizations exist for research data.
• Train staff on regulatory compliance and vet research personnel.

Connaissances

Regulatory oversight

IRB submissions

HIPAA compliance

Research administration

Formation

Bachelor’s degree

Outils

IRB portal

Description du poste

Primary Location:

Work from Home - KY Address: P.O. Box 909Louisville, KY 40201-0909 Shift: First Shift (United States of America)

Job Description Summary:

UofL Health is a fully integrated regional academic health system with five hospitals, four medical centers, nearly 200 physician practice locations, more than 700 providers, the Frazier Rehab Institute and Brown Cancer Center.With more than 12,000 team members—physicians, surgeons, nurses, pharmacists and other highly skilled health care professionals—UofL Health is focused on one mission: delivering patient-centered care to each and every patient each and every day.

Job Description:

Position is remote but candidate needs to be local.The Research Regulatory Coordinator Sr position is responsible for overseeing the regulatory aspects of clinical research studies taking place in UofL Health facilities and ULP clinics. The position communicates with the study team for each project and ensures regulatory requirements are met before the UofL Health Research Office (ULHRO) approval is granted. The position works closely with the UofL Health Clinical Research Review Committee (CRRC); the Interdisciplinary Research Oversight Council (IROC), the Research Regulatory Coordinator, the UofL Human Subjects Protection Program and External Institutional Review Boards (IRB). The Research Regulatory Coordinator Sr establishes standard operating procedures as needed to streamline operations and increase effectiveness and efficiency with the ULHRO team members and service line leaders. Position oversees processes to vet Research Personnel for access to EMRs and facilities. Position submits IRB applications for UofL Health employed staff and faculty to support Nursing Excellence initiatives and Pharmacy residency research.

Essential Functions:

Develop processes and procedures as needed to streamline regulatory oversight in the UofL Health Facilities and ULP clinicsReview 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 the project records and documents as required for UofL Health Institutional Review.Facilitate the Clinical Research Review Committee (CRRC) process for clinical research based on the operational impact to patient care teams to ensure feasibility of projects.Train, assist, and oversee the Research Regulatory Coordinator as needed to ensure appropriate vetting for research personnel who need access to our EMRs & facilities.Ensure a valid HIPAA authorization exists for all research involving UofL Health patients’ data.Work closely with the Interdisciplinary Research Oversight Council to support the magnet journey and evidence-based practice by advising nursing staff on policies and procedures for researchPrepare IRB submissions and maintain regulatory oversight for clinical research projects for UofL Health Nursing staff and Pharmacy residency as needed.

Other Functions:

Review completed consent forms for accuracy and compliance.Review documents included in IRB submissions and IRB correspondence regarding collection and release of UofL Health medical records data. This includes reviewing protocols, waivers, consent documents and data collection sheets to determine if any changes are needed for HIPAA authorization to be congruent with protocol.Maintains compliance with all company policies, procedures and standards of conductComplies with HIPAA privacy and security requirements to maintain confidentiality at all timesPerforms other duties as assigned

Additional Job Description:

Education:Bachelor’s degree (required)Experience:Experience in clinical research, human subjects’ protection regulations, including HIPAA authorizations, and IRB process (required)5 years of experience in research administration (preferred)Certification:Professional certification such as CCRP, CHRC, ACRP-CP (preferred)