Clinical Trials Regulatory Coordinator, Research Department, Kirk Kerkorian School of Medicine [R0153964]

Nevada System of Higher Education

About The Position

The Clinical Trials Regulatory Coordinator prepares, submits, maintains, and oversees regulatory documents needed to conduct clinical research studies in compliance with federal regulations, institutional policies, and sponsor requirements. The coordinator serves as the primary regulatory liaison among investigators, the Institutional Review Board (IRB), study sponsors, and regulatory agencies, helping ensure clinical trials follow Good Clinical Practice (GCP), FDA regulations, and institutional standards. The coordinator conducts clinical trial regulatory activities under the general guidance of the Director of the Office of Clinical Trials and the Associate Dean of Research, while working within the position’s scope and in accordance with federal and state laws and IRB-approved protocols. This is a full-time administrative faculty position in the Research Department of the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas.

Requirements

Bachelor’s degree from an accredited college or university, or an accepted equivalency: four additional years of relevant experience in lieu of a bachelor’s degree, or an associate’s degree plus two additional years of relevant experience.
At least two years of experience in clinical regulatory research, including grants or clinical protocols.
Credentials must be obtained prior to the employment start date.
Must be legally authorized to work in the United States at the time of hire and maintain work authorization throughout employment; visa sponsorship is not provided.

Nice To Haves

Clinical trial experience, specifically regulatory experience that includes pre-study preparation, activation, maintenance, and close-out.

Responsibilities

Prepare, submit, maintain, and oversee regulatory documents required for clinical research studies.
Serve as the primary regulatory liaison between investigators, the IRB, study sponsors, and regulatory agencies.
Support compliance with Good Clinical Practice, FDA regulations, institutional policies and standards, federal and state laws, sponsor requirements, and IRB-approved protocols.
Conduct clinical trial regulatory activities under the general guidance of the Director of the Office of Clinical Trials and the Associate Dean of Research.