Senior Clinical Research Specialist

Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia.

We are looking for an experienced Clinical Research Specialist to be responsible for leading device placement procedures, providing technical case support and supporting clinical sites as they identify and recruit patients for enrolment in Anteris clinical trials.  This individual can be based anywhere in the United States, with preference given to those in the Midwest or on the east coast, located near large travel hubs.

The Sr Clinical Research Specialist will provide training and procedural guidance to physicians and staff when placing and monitoring the investigational devices as well as be responsible for developing research partnerships with clinical sites. This individual will work closely with the Clinical Affairs operations team and cross-functional partners (R&D, Quality, Marketing) to drive enrolment and technology success. Join us!

In this role, you will:

• Demonstrate expertise in aspects of device implant, therapy, and troubleshooting techniques for DurAVR THV.
• Utilize acquired knowledge to educate physicians and staff to reach expert proficiency in the DurAVR THV procedure.
• Attend implants, conduct device preparation and crimping of the DurAVR valve in each assigned case; consult with physicians to support in the DurAVR THV procedure and clinical study protocol to deliver positive patient outcomes.
• Act as Site Leader in attendance at case treatments who provides case coverage support for study enrollments.
• Collaborate and partner with physicians and site staff to build trust and understanding of investigational site TAVR care pathways.
• Develop methods for identifying potential study patients and partner with the site to gather all input needed for patient screening and enrollment.
• Track all upstream activity of the patient pathway screening process and provide metrics per site on screening and enrollment.
• Build market and therapy support in preparation for product commercialization.
• Provide Study and Clinical Operations support; facilitate and collaborate with clinical operations team, to drive the site activation process.
• Identify operational improvement opportunities at the site level and recommend innovative new programs that incorporate site feedback and intel for enrollment acceleration initiatives, improved efficiency, and appropriate expanded therapy advancement tools and strategies.
• Partner with Clinical Operations team in support of data compliance activity, screening review efficiency and site submission efficiency.
• Provide feedback from clinical sites on the performance of the device to be incorporated in engineering designs or improvements.
• Interact with site investigators and study staff to solicit feedback and advice on product, procedural or clinical development activities.
• Provide feedback to cross-functional teams on market intelligence, physician preferences and clinical evidence dissemination.
• Provide perspective and feedback on clinical study design/protocol, as appropriate.
• Act in a manner that is globally inclusive to the company's AORTIC values: Accountability, Objectivity, Respect, Teamwork, Integrity, and Courage.

Basic Qualifications:

• Bachelor of Science in health sciences, nursing, or life sciences; graduate degree preferred.
• Must have a minimum of seven (7) years of medical device support and experience working in the sterile environment of a cath lab or operating room.
• Requires direct medical device clinical trial experience in Structural Heart / TAVR

Preferred Qualifications:

• Registered Nursing degree (RN), Certified Radiology Technician (CRT), or Cardiovascular Technician (RCIS) preferred.
• Expert clinical skills specifically in cardiac surgery or interventional cardiology are strongly preferred.
• Technically adept: understands data and mechanical systems.
• Ability to identify and adapt to shifting priorities and competing demands.
• Strong problem-solving skills and decision-making ability
• Ability to travel 50-70% of the time to clinical sites across the United States
• Independent, self-directed, and confident
• Creative problem identification and problem solving
• Outstanding communication skills as well as strong organizational/logistics skills
• Excellent interpersonal skills, interfacing with multiple constituencies including interventional cardiologists, cath lab staff, site support staff, and Anteris colleagues.
• Entrepreneurial spirit with a competitive drive and strong work ethic geared toward success.

Our Health and Wellness Offerings:

• Medical Offering
• Dental Offering
• Vision Offering
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Stock Option Plan
• Paid Holidays & Vacation
• Paid Parental Leave
• Employee Assistance Program
• Inclusive Team Environment

Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.

Anteris Technologies recruits, employs, trains, compensates and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.