Study Coordinator

Responsibilities

• Aids in the execution of complex trials for the research team.
• Supports the data management, clinical, and regulatory research teams.
• Trains new Study Coordinators and Data Coordinators.
• Improves, develops tools, processes, and forms to enhance efficiency and quality of work.
• Plans and tracks all assigned clinical activities throughout the lifecycle phases of startup, interim, and close-out.
• Updates clinical teams on protocol modifications and specifications, including visit schedules, assessment windows, dose modifications, and lab assessments.
• Creates study-specific tools for source documentation, checklists, and clinic information documents.
• Ensures study-specific tools are updated with any amendments or study changes.
• Attends monitor visits for each assigned trial at each monitoring visit.
• Reviews and comments on follow-up letters.
• Assists with reviews of trial data for responses to queries.
• Provides required study metrics to leadership.
• Assists with physician oversight by updating on protocol issues.
• Assists with sponsor and FDA audit preparation.
• Assists with reviews and responses to monitoring and auditing findings.
• Participates in sponsor meetings as assigned.

Qualifications

• Associate’s degree required, bachelor's degree preferred.
• Minimum 3 years research experience on interventional trials.