Sr Research Regulatory Coordinator, Remote

UofL Health; Louisville (KY); Hybrid; USD 70,000 - 95,000; Full time

Job summary

UofL Health is a fully integrated regional academic health system with five hospitals, four medical centers, nearly 200 physician practice locations and more than 700 providers.

The Research Regulatory Coordinator Sr oversees regulatory aspects of clinical studies across ULHRO, CRRC, IROC and external IRBs, ensuring compliance, proper documentation, and collaborative workflows for efficient approvals.

Qualifications

• Bachelor's degree required.
• Experience in clinical research and IRB process required.
• 5 years of experience in research administration preferred.
• Certification such as CCRP/CHRC/ACRP-CP preferred.

Responsibilities

• Develop regulatory oversight processes for ULHRO facilities and clinics.
• Review IRB correspondence, determine actions, document in ULHRO system.
• Prepare IRB submissions and maintain regulatory oversight for nursing and pharmacy research.
• Facilitate CRRC processes with impact on patient care teams.
• Vet research personnel for EMR and facility access; ensure HIPAA authorization is in place.
• Collaborate with IROC to support nursing practice and magnet journey.
• Maintain compliance with HIPAA privacy and security requirements.

Skills

Regulatory oversight

IRB process

HIPAA compliance

EMR access control

Interdisciplinary collaboration

Training & coaching

Education

Bachelor's degree

CCRP, CHRC, ACRP-CP (preferred)

Job description

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.

Address

P.O. Box 909 Louisville, 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)