Clinical Trials Regulatory Coordinator — Drive Study Compliance

UNLV; Las Vegas, Northern (NV, KY); Hybrid; USD 70.000 - 100.000; Vollzeit

Zusammenfassung

UNLV's Clinical Trials Regulatory Coordinator in the Research Department supports the regulatory lifecycle of clinical studies, ensuring regulatory documents and submissions are complete, accurate, and compliant.

This role serves as the primary liaison between investigators, IRB, study sponsors, and regulatory agencies, guiding trials from activation through close-out while upholding GCP, FDA regulations, and institutional standards.

Qualifikationen

• Minimum two years of experience in clinical regulatory research including grants or clinical protocols.
• Bachelor’s Degree from an accredited college or university; substitutions allowed with additional relevant experience as described.

Aufgaben

• Prepare, submit, maintain regulatory documents for clinical studies.
• Serve as liaison between investigators, IRB, sponsors, and regulatory agencies.
• Ensure trials comply with GCP, FDA regulations, and institutional standards.

Kenntnisse

Regulatory knowledge

GCP awareness

FDA regulations

Ausbildung

Bachelor’s Degree

Jobbeschreibung

UNLV's Clinical Trials Regulatory Coordinator in the Research Department supports the regulatory lifecycle of clinical studies, ensuring regulatory documents and submissions are complete, accurate, and compliant.

This role serves as the primary liaison between investigators, IRB, study sponsors, and regulatory agencies, guiding trials from activation through close-out while upholding GCP, FDA regulations, and institutional standards.