Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the leading cause of death worldwide, using advanced technology. Their flagship product is an AI-driven, non-invasive cardiac test known as the Heartflow FFR_CT Analysis, which provides a 3D color-coded model of coronary arteries indicating blood flow blockages. Heartflow offers integrated heart care solutions across the CCTA pathway, helping clinicians identify stenoses, assess blood flow, and quantify atherosclerosis. The company is publicly traded (HTFL), internationally recognized, supported by medical societies globally, and cleared for use in the US, UK, Europe, Japan, and Canada.

Manage multiple Investigator Initiated Clinical studies including regulatory document collection, contracting process assistance, study progress tracking, and communication with external study teams and internal teams. Maintain study databases and files, ensuring accuracy and compliance with HIPPA privacy laws. Site management activities for HeartFlow sponsored study sites such as enrollment support, answering protocol questions, data review, visit progress tracking, payment tracking, regulatory documentation maintenance, and training of study staff. Conduct study start-up activities including reviewing consent forms, regulatory documentation collection, IRB submissions, building study binders, and contracting. Provide clinical project support such as maintaining Clinical Trial Master Files, reviewing documents and monitoring reports, updating SOPs, and documenting meeting minutes. Manage and track finances against study budgets and invoices. Assist in the development of study tools and documents including electronic databases, CRFs, source documents, logs, and forms. Perform other duties as needed.

Excellent written and oral English skills, strong interpersonal and organizational skills, attention to detail, ability to learn quickly and work independently or in teams, analytical skills, proficiency in Microsoft Office and Google Applications, professional interaction, self-starter with multitasking and prioritization abilities, and knowledge of ICH-GCP guidelines and FDA regulations preferred.

BA or BS degree in a science or related field, with 3+ years demonstrated experience in human clinical research trials or equivalent.

The estimated yearly base compensation range is $85,000 to $120,000 plus cash bonus. The position is hybrid, requiring presence in the office 3 days a week.

Heartflow is committed to diversity and equal opportunity, not discriminating based on race, color, religion, age, gender identity, or other protected categories. The company emphasizes safe recruitment practices and warns about fraud attempts by impersonators.