Specialist, Clinical Education THV (Southeast US)

Edwards Lifesciences • Atlanta, GA

16d

About The Position

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. You will make an impact by: Pre-Procedural, Intra-Procedural, Post-Procedural Case Support Represent the Clinical Affairs Research Team during clinical trial cases with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time guidance during clinical trial implants, including contingency planning to address unforeseen occurrences in support of assigned clinical investigations Provide education on all aspects of the device, device handling, implantation and troubleshooting techniques related to equipment, tools and products required for device implants Document procedural case observations for insights in investigating post procedural events Education Support Develop and continuously improve training curriculum, training materials and training tools, based on clinical trial experience Educate and train physicians, hospital personnel and hospital staff on technical matters related to investigational products and procedures through conducting and/or coordinating one-on-one ad hoc training sessions and in-service structured education programs Throughout clinical investigations, provide physicians and medical staff with required follow-up support to ensure continuity of education and technical support related to all aspects of clinical research Assist in Clinical Monitoring activities Ensure device accountability by tracking the location of all clinical trial devices. Manage inventory to include par levels, expiration dates, and initiate shipments and returns of investigational products according to regulatory and company guidelines Collaborate with product development teams to provide feedback on device iterations and new device development

Requirements

• Bachelor's Degree & a minimum of 3 years clinician experience in intra-operative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Radiologic Technologist (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) or related medical device, clinical, or
• Certification in RDCS (Registered Diagnostic Cardiac Sonographer) within ARDMS (American Registry for Diagnostic Medical Sonography) OR equivalent work experience based on Edwards criteria
• Ability to travel up to 75%
• COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Nice To Haves

• Previous proctoring experience
• Experience in interventional cardiology, cardiothoracic surgery, hemodynamic monitoring technology
• Knowledge and understanding of cardiovascular science
• Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

Responsibilities

• Represent the Clinical Affairs Research Team during clinical trial cases with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time guidance during clinical trial implants, including contingency planning to address unforeseen occurrences in support of assigned clinical investigations
• Provide education on all aspects of the device, device handling, implantation and troubleshooting techniques related to equipment, tools and products required for device implants
• Document procedural case observations for insights in investigating post procedural events
• Develop and continuously improve training curriculum, training materials and training tools, based on clinical trial experience
• Educate and train physicians, hospital personnel and hospital staff on technical matters related to investigational products and procedures through conducting and/or coordinating one-on-one ad hoc training sessions and in-service structured education programs
• Throughout clinical investigations, provide physicians and medical staff with required follow-up support to ensure continuity of education and technical support related to all aspects of clinical research
• Ensure device accountability by tracking the location of all clinical trial devices.
• Manage inventory to include par levels, expiration dates, and initiate shipments and returns of investigational products according to regulatory and company guidelines
• Collaborate with product development teams to provide feedback on device iterations and new device development

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees