Sr Research Regulatory Coordinator, Remote

UofL Health; New York (NY); Hybrid; USD 90,000 - 110,000; Full time

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.

Skills

Regulatory oversight

IRB procedures

HIPAA compliance

Training & mentoring

Communication with study team

Education

Bachelor’s degree

Tools

IRB submission systems

EMR access vetting tools

Job description

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 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 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 research.
• Prepare 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 conduct
• Complies with HIPAA privacy and security requirements to maintain confidentiality at all times
• Performs other duties as assigned

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)