Job Information
Scitech Development, Inc Clinical Trial Coordinator in Grosse Pointe Farms, Michigan
Coordinate and support clinical trials across start-up, conduct, and close-out; prepare and submit IRB/IEC applications and amendments; maintain study master files and documentation in compliance with ICH-GCP and applicable regulations; track timelines, enrollment, and visit schedules; oversee data collection and query resolution in EDC/CRFs and assist with PK/PD sample tracking and vendor communications; monitor safety reporting workflows (AEs/SAEs) to ensure timely notifications; liaise with Principal Investigators, research sites, and cross-functional teams to ensure protocol adherence and data quality; assist with development of study tools (source documents, checklists) and prepare periodic status reports for management and stakeholders.