Clinical Trials Project Specialist

Job Summary

Supporting clinical research project management, the full-time Clinical Trials Project Specialist will manage study documentation, collaborate with interdisciplinary teams, and coordinate Data and Safety Monitoring Board operations in a remote setting.

Key responsibilities

• Manages processing, tracking, and filing of essential study documentation, including adverse event reports and Investigator Brochures
• Collaborates with Investigators and study teams to maintain regulatory documents within a Trial Master File (TMF)
• Coordinates Data and Safety Monitoring Board operations, including report preparation and monitoring implementation of recommendations

Required qualifications

• Bachelor's degree in a related field or equivalent combination of education and experience
• Knowledge of ICH Good Clinical Practice (GCP) guidelines and relevant federal, state, and local regulations
• Two years of related experience in regulatory affairs or clinical trials coordination
• Strong organizational skills and proficiency in MS Office
• Ability to manage multiple projects simultaneously without adverse effects