Senior Research Regulatory Coordinator, Remote

UofL Health; Lexington (KY); Remote; USD 70,000 - 100,000; 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. The role collaborates with ULHRO, CRRC, IROC, and nursing/pharmacy research teams to ensure compliance and efficient study start-up.

The position requires a Bachelor’s degree, 5 years of research administration experience, and HIPAA/IRB knowledge. Remote work is possible for local candidates; travel to sites as needed; professional

Qualifications

• Bachelor’s degree required.
• 5 years in research administration preferred; HIPAA and IRB experience required.
• Experience in clinical research and human subjects protection regulations.
• Professional certification such as CCRP, CHRC, or ACRP-CP preferred.

Responsibilities

• Develop processes to streamline regulatory oversight in health facilities and clinics.
• Review IRB correspondence and document actions in ULHRO.
• Prepare IRB submissions and maintain regulatory oversight for nursing and pharmacy research.
• Ensure HIPAA authorizations and data privacy compliance.
• Train and oversee staff vetting for EMR access.
• Ensure HIPAA privacy and security requirements are followed.

Skills

Regulatory oversight

IRB process knowledge

HIPAA compliance

Clinical research coordination

Stakeholder communication

Education

Bachelor’s degree

Tools

EMR access control

IRB submission systems

ULHRO workflow 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 & 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 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 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)