Clinical Trials Regulatory Coordinator, Research Department, Kirk Kerkorian School of Medicine[R0152658]
About The Position
The Clinical Trials Regulatory Coordinator is responsible for the preparation, submission, maintenance, and oversight of regulatory documents required for the conduct of clinical research studies in compliance with federal regulations, institutional policies, and sponsor requirements. This role serves as the primary regulatory liaison between investigators, the Institutional Review Board (IRB), study sponsors, and regulatory agencies, ensuring that all clinical trials are conducted in accordance with Good Clinical Practice (GCP), FDA regulations, and institutional standards. The Clinical Trials Regulatory Coordinator will conduct clinical trial regulatory activities under the general guidance of the Director of the Office of Clinical Trials, and Associate Dean of Research. The coordinator will perform duties within in the scope of the position while following federal and state laws, and IRB approved protocols.
Requirements
- Bachelor’s Degree from an accredited college or university recognized by the United States Department of Education and/or the Council on Higher Education Accreditation (CHEA).
- 2-4 years of experience.
- Minimum two years of experience in clinical regulatory research including grants or clinical protocols.
- Credentials must be obtained prior to the employment start date.
Nice To Haves
- Clinical trial experience, specifically regulatory, including pre-study preparation, activation, maintenance, and close-out.
Responsibilities
- Preparation, submission, maintenance, and oversight of regulatory documents for clinical research studies.
- Ensuring compliance with federal regulations, institutional policies, and sponsor requirements.
- Serving as the primary regulatory liaison between investigators, IRB, study sponsors, and regulatory agencies.
- Ensuring clinical trials are conducted in accordance with Good Clinical Practice (GCP), FDA regulations, and institutional standards.
- Conducting clinical trial regulatory activities under the general guidance of the Director of the Office of Clinical Trials and Associate Dean of Research.
- Performing duties within the scope of the position while following federal and state laws, and IRB approved protocols.
Benefits
- Paid time off, sick leave, and holidays
- Excellent health insurance including medical, dental and vision
- Comprehensive retirement plans and voluntary benefits programs
- No state income tax
- Tuition discounts at Nevada System of Higher Education (NSHE) schools
- Tuition discounts for spouses, domestic partners, and dependents
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
