Sr Research Regulatory Coordinator, Remote

UofL Health•Work from Home - KY, KY

2d•Remote

About The Position

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. This remote position requires the candidate to be local to KY.

Requirements

Bachelor’s degree
Experience in clinical research
Experience in human subjects’ protection regulations, including HIPAA authorizations
Experience with the IRB process

Nice To Haves

5 years of experience in research administration
Professional certification such as CCRP, CHRC, ACRP-CP

Responsibilities

Overseeing the regulatory aspects of clinical research studies taking place in UofL Health facilities and ULP clinics.
Communicating with study teams and ensuring regulatory requirements are met before ULHRO approval.
Working 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).
Establishing standard operating procedures to streamline operations and increase effectiveness and efficiency with the ULHRO team members and service line leaders.
Overseeing processes to vet Research Personnel for access to EMRs and facilities.
Submitting IRB applications for UofL Health employed staff and faculty to support Nursing Excellence initiatives and Pharmacy residency research.
Developing processes and procedures to streamline regulatory oversight.
Reviewing all IRB correspondence, determining action items, and documenting content in the ULHRO system.
Reviewing submissions to the ULHRO and establishing project records and documents for UofL Health Institutional Review.
Facilitating the CRRC process for clinical research based on operational impact to patient care teams.
Training, assisting, and overseeing the Research Regulatory Coordinator.
Ensuring a valid HIPAA authorization exists for all research involving UofL Health patients’ data.
Working closely with the Interdisciplinary Research Oversight Council to support the magnet journey and evidence-based practice by advising nursing staff on research policies and procedures.
Preparing IRB submissions and maintaining regulatory oversight for clinical research projects for UofL Health Nursing staff and Pharmacy residency.
Reviewing completed consent forms for accuracy and compliance.
Reviewing documents included in IRB submissions and IRB correspondence regarding collection and release of UofL Health medical records data.
Maintaining compliance with all company policies, procedures, and standards of conduct.
Complying with HIPAA privacy and security requirements.
Performing other duties as assigned.