FSP Clinical Trial Coordinator II

Clinical Trial Coordinator II supporting clinical operations at a contract research organization managing 2,700+ trials globally. The role involves administrative and technical support for trial activities, file management, site activation, feasibility assessments, and coordination with investigators and internal teams.

Responsibilities

• Coordinate and complete assigned trial activities including file reviews, document processing, and eTMF management
• Support site activation planning, feasibility assessments, and investigator relationship development
• Process documents, track regulatory compliance items, and maintain study metrics and reporting
• Assist with preparation and distribution of investigator site files, pharmacy materials, and study supplies to sites
• Train new personnel on processes and systems, and support departmental process improvements

Requirements

• Knowledge of clinical trial SOPs, regulatory guidelines, and investigator site file management
• Experience with electronic trial master files (eTMF) and clinical trial management systems (CTMS)
• Strong administrative and organizational skills with ability to manage multiple tasks and timelines
• Ability to communicate effectively with internal teams, site personnel, and investigators
• Detail-oriented with experience in document processing, data reconciliation, or compliance review
• Proficiency in Microsoft Office and database systems