Anteris Technologies

Clinical Specialist

• Help support the execution of clinical trials while advancing clinical evidence and valve science.
• Provide procedural and clinical trial case support, contribute to trial enrolment, and identify ongoing educational opportunities for heart team members and the broader referring community.
• Collaborate closely with Clinical Affairs, Regulatory Affairs, R&D, Quality and Marketing to support optimal clinical outcomes and achieve enrolment objectives aligned with the company’s goals and strategy.
• Attend assigned clinical cases and support the heart team with preparation and loading of the DurAVR valve.
• Maintain in-depth knowledge of existing DurAVR clinical data and the evolving structural heart evidence landscape.
• Uphold the company’s AORTIC values: Accountability, Objectivity, Respect, Teamwork, Integrity and Courage.

Clinical Specialist – TAVR

Nurse

• Lead the end‑to‑end screening process, ensuring all pre‑procedure assessments (e.g. CT, echo, labs, risk scoring) are completed accurately and on time across participating sites.
• Lead scientific and operational evaluation of inclusion/exclusion criteria, providing clear, defensible decisions on subject eligibility in alignment with the protocol and regulatory expectations.
• Partner with investigators, coordinators, and field teams to drive screening performance, troubleshoot barriers, and ensure consistent application of screening criteria.
• Collaborate with cardiologists, study coordinators, and clinical teams to prioritize potential participants.
• Provide clinical insights to support case planning and feasibility discussions.
• Ensure compliance with GCP, FDA, and trial protocols during all screening activities.
• Lead live screening meetings to review cases and discuss patient eligibility trends.
• Ensure completeness, accuracy, and protocol compliance of all screening‑related data; identify trends, gaps, and risks requiring corrective action.

Research Nurse Coordinator

• Successfully complete the Anteris internal training programme, including demonstrating competency in CT and echocardiographic imaging, the applicable Instructions for Use, procedural best practices, clinical evidence, approved product messaging and the competitive landscape.
• Interface with clinical trial sites, demonstrating expertise in all technical aspects of TAVI clinical case support, training and education, customer service and communication.
• Demonstrate competency in all procedural aspects of DurAVR® THV case support, including valve preparation and loading, device delivery and implantation, complication mitigation and troubleshooting, in accordance with the clinical trial protocol and established best practices.
• Demonstrate a thorough understanding of the approved DurAVR clinical trial protocol, including inclusion and exclusion criteria and requirements for pre- and post-procedure imaging and clinical data.
• Demonstrate proficiency in pre-case planning, CT analysis and pre- and post-procedure recommendations to support optimal clinical outcomes.
• Maintain in-depth knowledge and understanding of existing DurAVR clinical data and the evolving structural heart evidence landscape.
• Support the Clinical and Regulatory Operations teams with site communications, data compliance activities, screening review efficiency and site submission requirements.
• Attend assigned clinical cases and support the heart team with preparation and loading of the DurAVR valve.
• Provide education and guidance to physicians and site personnel regarding the identification of appropriate study participants and support complete and accurate patient screening and enrolment documentation.
• Track patient screening pathway activity and routinely provide site-level metrics related to screening progress and trial enrolment.
• Identify operational improvement opportunities at the site level and recommend strategies to accelerate enrolment, improve efficiency and appropriately advance therapy adoption.
• Maintain accurate and timely documentation of case support, site activity, training and other required clinical trial information.
• Comply with all applicable Australian regulations, clinical trial requirements, company policies and site-specific procedures.
• Uphold the company’s AORTIC values: Accountability, Objectivity, Respect, Teamwork, Integrity and Courage.

Compliance

• Support clinical research, physician engagement, global regulatory strategy, and advancement of therapies.
• Roles include Clinical Project Manager, Clinical Research Associate, Clinical Research Scientist, Clinical Specialist, and Regulatory Affairs Specialist.

Clinical and Regulatory Affairs

• Perform detailed review and analysis of cardiac CT scans for patients being considered for enrollment in global 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, valve morphology, and other structural heart considerations.
• Utilize advanced imaging platforms, including 3Mensio or equivalent 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, recommendations, and screening outcomes.
• Collaborate with Clinical Science, Clinical Operations, Therapy Development, and Field Clinical teams across Europe, North America, and Asia-Pacific to support timely patient screening and enrollment activities.
• Participate in multidisciplinary case review discussions, screening conferences, and physician review meetings.
• Prepare and present patient imaging analyses during screening conferences and physician case planning sessions.
• Support protocol compliance and consistency in imaging review processes across participating global clinical sites.
• Contribute to the development, refinement, and standardization of imaging review workflows and best practices.
• Serve as a clinical imaging resource for investigators, physicians, study coordinators, and site personnel regarding imaging requirements and screening processes.
• Partner with physicians and Field Clinical Specialists to facilitate patient-specific procedural planning discussions.
• Communicate imaging findings clearly and effectively to both internal and external stakeholders.
• Assist clinical sites in obtaining complete, high-quality CT imaging submissions.
• Ensure all activities are performed in accordance with applicable global regulatory requirements, ICH-GCP guidelines, company policies, and quality system requirements.
• Maintain patient confidentiality and data privacy in accordance with GDPR, applicable local privacy regulations, and study requirements.
• Support audit readiness, inspection preparedness, and documentation compliance.
• Participate in continuous improvement initiatives related to imaging review, patient screening, and clinical operations.

Clinical Specialist – TAVR

Research Nurse Coordinator

Clinical Specialist – TAVR

Clinical and Regulatory Affairs

Clinical Imaging Specialist