Clinical Trials Regulatory Coordinator, Research Department, Kirk Kerkorian School of Medicine[R0152658]
UNLV Department of Accounting · Memphis, Tennessee, United States · 1 mo ago
LegalFull-time
About the role
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.
Responsibilities
- Prepare, submit, and maintain regulatory documents for clinical research studies.
- Ensure compliance with federal regulations, institutional policies, and sponsor requirements.
- Conduct clinical trial regulatory activities under the guidance of the Director of the Office of Clinical Trials and Associate Dean of Research.
- Interact with investigators, IRB, study sponsors, and regulatory agencies to address regulatory issues.
- Support the coordination of clinical trials from initiation to completion.
Requirements
- Minimum two years of experience in clinical regulatory research including grants or clinical protocols.
- Preferred qualifications include clinical trial experience, specifically regulatory, including pre-study preparation, activation, maintenance, and close-out.
Qualifications
- Bachelor’s Degree from an accredited college or university as recognized by the United States Department of Education and/or the Council on Higher Education Accreditation (CHEA).
- Minimum two years of experience in clinical regulatory research including grants or clinical protocols.
- Preferred qualifications include clinical trial experience, specifically regulatory, including pre-study preparation, activation, maintenance, and close-out.
Skills
- Strong knowledge of Good Clinical Practice (GCP) guidelines.
- Experience with regulatory submissions and maintenance of regulatory documents.
- Ability to manage multiple projects simultaneously and meet deadlines.
- Excellent communication and interpersonal skills.
- Proficiency in Microsoft Office Suite.
Benefits
Competitive total rewards package including:
- 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
- Employee recognition and appreciation programs
- Wellness programming for all UNLV faculty and staff at no cost
- Career advancement opportunities to leadership roles
- Onboarding program, Rebels: Onboard
Pay
Salary competitive with those at similarly situated institutions.
Schedule
Full-time equivalent 100.0%