Company Overview

Job Responsibilities

• Manage multiple Investigator Initiated Clinical studies, including regulatory document collection, contracting assistance, progress tracking, communication with external and internal teams, participation in project meetings, and maintaining study databases and files in compliance with HIPPA.
• Conduct site management activities for HeartFlow sponsored study sites, addressing enrollment issues, answering protocol and EDC questions, reviewing data for accuracy, tracking study progress, monitoring payments, maintaining regulatory documentation, and training study staff.
• Perform study startup activities, e.g., reviewing informed consent forms, collecting regulatory documents, assisting IRB submissions, building study binders and materials, contracting support, and clinical project support including filing TMFs, document review, monitoring reports, SOP updates, and meeting minute documentation.
• Manage and track finances against study budgets, collect and track invoices, and liaise with the Finance department.
• Assist in developing Heartflow sponsored study tools and documents such as electronic databases, CRFs, source documents, logs, and forms.
• Perform other duties as needed.

Skills Needed

• Excellent written and oral English skills
• Strong interpersonal skills
• Excellent organizational skills
• Strong attention to detail and follow-through
• Ability and willingness to learn quickly with little supervision
• Ability to work independently and in a team
• Strong analytical and problem-solving skills
• Proficiency in Microsoft Office and Google Applications
• Professional internal and external communication
• Self-starter capable of multitasking and prioritizing under pressure
• Knowledge of ICH-GCP guidelines and FDA regulations preferred

Educational Requirements & Work Experience

• BA or BS degree in a science or related field
• 3+ years of experience in human clinical research trials or equivalent

Equal Opportunity Employer Statement