Clinical Research Regulatory Specialist Ii

University of Rochester

Rochester, New York, United States of America
Hourly: $24.91 - $34.87; bonus/equity: not specifi...
Prepare regulatory documentation and filings
Maintain oncore and complion tracking systems
Submit irb and fda regulatory reports
The University of Rochester is committed to the Meliora ideal of being Ever Better through shared values of equity, leadership, and integrity

Job Summary

  • The University of Rochester is committed to the Meliora ideal of being Ever Better through shared values of equity, leadership, and integrity.
  • This role involves preparing all regulatory documentation, maintaining logs in OnCore and Complion, and coordinating submissions to the Institutional Review Board and FDA.
  • The position requires acting as a liaison between study teams, sponsors, and various committees while ensuring strict adherence to federal and institutional policies.

Matching Summary

The University of Rochester is committed to the Meliora ideal of being Ever Better through shared values of equity, leadership, and integrity.

Salary

Hourly: $24.91 - $34.87; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Prepare regulatory documentation and filings
  • Maintain OnCore and Complion tracking systems
  • Submit IRB and FDA regulatory reports
  • Coordinate protocol annual reviews and revisions
  • Ensure Good Clinical Practice compliance

Nice-to-have

  • Manage multiple competing priorities effectively
  • Build collaboration among diverse research teams
  • Demonstrate self-motivation and independent function
  • Deep knowledge of therapeutic area trends
  • Strong interpersonal communication skills

Key Requirements

  • Bachelor's degree required
  • 1 year of relevant experience required
  • Proficiency in MS Office applications
  • CITI certification maintenance
  • Knowledge of GCP and CFR standards

Work Rights

Not specified

Tailored Resume

Cover Letter