Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease.

Develops clinical education materials in connection with clinical investigations.

PRE-PROCEDURAL, INTRA-PROCEDURAL, POST-PROCEDURAL CASE SUPPORT

Represent the Clinical Affairs Research Team during complex 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. Support enrollment discussions and assistance with issue escalation with Principal Investigator and research team

EDUCATION SUPPORT

Educate and train physicians, hospital personnel 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.

Provide field training and guidance to new Clinical Specialists.

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.

Develop and continuously improve training materials, training tools, and curriculum, based on clinical trial experience

RESEARCH SUPPORT

May develop material content and communications with investigational content for presentation at congresses and conventions and distribution to clinical sites.

May interface with investigation and clinical research staff to manage logistics associated with investigational meeting attendance, and protocol and device training.

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.

May support leadership of team initiatives

Collaborate with product development teams to provide feedback and recommend solutions on device iterations and new device development.

Assist in Clinical Monitoring activities

Bachelor's Degree in related field.

5 years of previous related medical device and/or clinical knowledge Required

Clinician knowledge 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) Preferred

Knowledge in interventional cardiology or cardiothoracic surgery Preferred

English and Spanish level required

Proven expertise in MS Office Suite and ability to operate general office machinery

Strong written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills

Excellent problem-solving and critical thinking skills

Full knowledge and understanding of cardiovascular science

Full understanding of cardiovascular anatomy, pathology and physiology

Full understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

Ability to manage confidential information with discretion

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects

Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control