Clinical Protocol Coordinator

Job Summary

Supporting the oversight and management of clinical trials and large-scale epidemiological studies, the full-time Clinical Protocol Coordinator will prepare documentation, ensure regulatory compliance, and coordinate with various stakeholders while working remotely or from Bethesda, Maryland.

Key responsibilities

• Manage clinical trial documentation and Data and Safety Monitoring Board activities to ensure compliance
• Prepare and maintain FDA regulatory submissions, including IND and IDE applications
• Coordinate communications with NIH Institutes, clinical sites, and oversight organizations

Required qualifications

• Master's degree in Biology, Life Sciences, Health and Medical Administrative Services, or a related field
• Minimum of ten years of experience in clinical trials oversight or clinical research administration
• Experience coordinating multi-center Phase I, II, and III clinical trials
• Ability to prepare and maintain FDA regulatory submissions
• Demonstrated technical writing experience related to clinical trials and regulatory documentation