Senior Regulatory Research Coordinator

Job Summary

A company is looking for a Senior Regulatory Research Coordinator responsible for managing regulatory submissions for clinical trials.

Key Responsibilities

• Serve as the primary regulatory contact for assigned protocols
• Maintain electronic regulatory binders/files and coordinate submissions to ancillary committees
• Prepare and submit study amendments and regulatory files for auditing and monitoring visits

Required Qualifications

• High school diploma with 6 years of clinical research experience, or a Bachelor's degree with 2 years, or a Master's degree with 1 year of clinical research experience
• SOCRA Certification preferred
• Experience with grant-funded and investigator-initiated clinical trials
• Knowledge of Good Clinical Practices and relevant FDA and NIH regulations
• Familiarity with clinical trial management systems and Microsoft Office applications