Senior Regulatory Research Coordinator

Job Summary

A company is looking for a Senior Regulatory Research Coordinator dedicated to supporting a complex portfolio of investigator-initiated trials.

Key Responsibilities

• Serve as the primary regulatory contact for assigned protocols
• Maintain electronic regulatory binders/files and ensure appropriate version control
• Coordinate submissions to ancillary committees and communicate with the IRB and sponsors regarding regulatory management

Required Qualifications

• High school diploma with 6 years of clinical research experience and SOCRA Certification, or a Bachelor's degree with 2 years of clinical research experience, or a Master's degree with 1 year of clinical research experience
• Experience working with grant-funded and Investigator-Initiated clinical trials
• Knowledge of Good Clinical Practices, FDA Rules and Regulations, NIH guidelines, ICH guidelines, and HIPAA regulations related to clinical trials
• Familiarity with clinical research terminology and processes
• Experience with clinical trial management systems, such as OnCore and ClinicalTrials.gov