Edwards Lifesciences Senior Specialist, Clinical Education- Forecasted Opportunity in Irvine, California
This position has been posted in anticipation for future openings within Clinical Research. We anticipate hiring a Senior Specialist, Clinical Education If you meet the minimum job requirements, you will receive additional information about our Clinical Affairs Talent Community. .
Develops clinical education materials in connection with clinical investigations.
• PRE-PROCEDURAL, INTRA-PROCEDURAL, POST-PROCEDURAL CASE SUPPORT
o 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.
o Provide education on all aspects of the device, device handling, implantation and troubleshooting techniques related to equipment, tools and products required for device implants.
o 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
o 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.
o Provide field training and guidance to new Clinical Specialists.
o 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.
o Develop and continuously improve training materials, training tools, and curriculum, based on clinical trial experience
• RESEARCH SUPPORT
o May develop material content and communications with investigational content for presentation at congresses and conventions and distribution to clinical sites.
o 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
• Other incidental duties
Education and Experience:
Bachelor's Degree in in related field, 5 years years experience of previous related medical device and/or clinical experience Required
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) Preferred
Experience in interventional cardiology or cardiothoracic surgery Preferred
• 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 EHS rules and requirements 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.