Primary Duties and Responsibilities
Imaging Review & Patient Screening
• Perform detailed review and analysis of cardiac CT scans for patients being considered for enrollment in clinical studies.
• Evaluate imaging data to support patient eligibility and screening decisions.
• Assess anatomical characteristics relevant to TAVR procedural planning, including aortic annulus sizing, vascular access, calcium distribution, coronary heights, and other structural heart considerations.
• Utilize advanced imaging platforms and software to perform measurements and generate screening reports.
• Identify and escalate imaging findings that may impact patient eligibility, procedural planning, or study participation.
• Maintain accurate documentation of imaging assessments and screening outcomes.
Clinical Trial Support
• Collaborate with Clinical Science, Clinical Operations, and Field Clinical teams to support timely patient screening and enrollment activities.
• Participate in multidisciplinary case review discussions and screening meetings.
• Assist with preparation and presentation of patient imaging data and PowerPoint presentations during screening conferences and physician review sessions.
• Support protocol adherence and consistency in imaging review processes across participating sites.
• Contribute to the development and refinement of imaging review workflows and best practices.
Education & Training
• Contribute to the development and refinement of imaging review workflows and best practices.
• Develop internal materials focused on CT interpretation, TAVR planning, ViV, and bicuspid anatomy.
• Assist with training programs for Field Clinical Specialists
Quality & Compliance
• Ensure all activities are performed in accordance with FDA regulations, GCP guidelines, company policies, and applicable quality system requirements.
• Maintain patient confidentiality and data security in accordance with HIPAA and study requirements.
• Support audit readiness and inspection preparedness activities as needed.
• Participate in continuous improvement initiatives related to imaging review and screening processes.