Regulatory Analyst I

Job Summary

To support clinical trials from start-up to closure, the full-time Regulatory Analyst I will prepare and submit regulatory documentation, maintain compliance with federal and institutional regulations, and provide regulatory support for multiple studies in a remote capacity.

Key responsibilities

• Facilitates the preparation and submission of regulatory documentation for clinical trials to various boards and sponsors
• Maintains and updates essential regulatory documents, ensuring compliance with SOPs, FDA, and NIH regulations
• Communicates with study staff and sponsors to ensure accurate maintenance of regulatory files and documentation

Required qualifications

• Bachelor's Degree in a relevant field
• Minimum of one (1) year of relevant experience in compliance, research, or clinical settings
• Knowledge of clinical trial processes and applicable federal, state, and local regulations
• Proficiency in Microsoft Office and experience with databases and regulatory documentation
• Ability to maintain effective working relationships with diverse teams and stakeholders