Senior Research Regulatory Coordinator, Remote

UofL Health; Central City (KY); Remote; USD 65,000 - 90,000; Full time

Job summary

UofL Health is seeking a Research Regulatory Coordinator Sr to oversee regulatory aspects of clinical studies across ULHRO and affiliated clinics. This remote-enabled role requires local presence for occasional site activities and collaboration with study teams to ensure regulatory requirements are met before ULHRO approval.

You will develop SOPs, vet research personnel for EMR access, review IRB submissions, and coordinate with CRRC and IROC, nursing and pharmacy researchers to support Nursing

Qualifications

• Experience in clinical research and regulatory oversight.
• Knowledge of HIPAA protections and IRB processes.
• Experience in human subjects’ protection regulations.

Responsibilities

• Develop regulatory oversight procedures for ULHRO and clinics.
• Review IRB correspondence and document actions in ULHRO system.
• Prepare and submit IRB applications for ULHRO staff and faculty.
• Facilitate CRRC processes to support project feasibility.
• Train and supervise staff in research regulatory procedures.
• Ensure HIPAA authorization validity for research data.
• Maintain compliance with all policies and conduct standards.

Skills

Clinical research

IRB process

HIPAA compliance

Education

Bachelor's degree

CCRP/CHRC/ACRP-CP preferred

Job description

Primary Location: Work from Home - KY 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)