Clinical Research Regulatory Specialist

Job Summary

Collaborating with the operations team and practices, the full-time Clinical Research Regulatory Specialist will ensure compliance with regulatory requirements for clinical research projects, manage regulatory activities, and facilitate the regulatory aspects of clinical trials in a remote capacity.

Key responsibilities

• Ensure adherence to evolving regulatory requirements and disseminate updates to network team members
• Manage a high-volume portfolio of regulatory activities, tracking timelines and communicating status updates
• Prepare and maintain regulatory documents, coordinating submissions to regulatory authorities and ethics committees

Required qualifications

• Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, nursing) required; advanced degree preferred
• Minimum of 1-2 years of experience in clinical research, focusing on regulatory affairs and compliance
• At least 1 year of experience with IRB submissions
• Proficiency in Microsoft Office applications and familiarity with electronic data capture (EDC) systems
• Experience with clinical trial management systems (CTMS) preferred