OrganOx

Clinical Research

• Gain in-depth knowledge of OrganOx FDA-approved and investigational/research products and associated clinical procedures
• Serve as the subject matter expert on devices and procedures during IDE studies and research projects
• Support training of OrganOx employees and customers on approved, IDE, and research products and studies
• Support development of training and support materials for devices, procedures, and clinical protocols
• Train investigational/research centers, Clinical Specialists, and OrganOx personnel
• Attend cases with investigational/research devices as a technical and clinical resource
• Interface with Development and Engineering on technical questions
• Provide clinical and technical feedback to Development and Engineering
• Support investigational/research centers and OrganOx personnel regarding devices and clinical study protocols
• Support development of clinical study protocols
• Support thorough data collection and protocol-compliant data analysis
• Develop materials for clinical protocols, study procedures, data collection, and review
• Assist with development and implementation of study-specific clinical databases
• Assist Clinical Research Associates with study data review
• Support writing and review of clinical study reports and clinical portions of FDA submissions
• Identify and report protocol challenges and compliance issues to clinical management
• Maintain and develop professional relationships with investigators and research sites
• Support clinical management with departmental quality improvement decisions
• Perform other duties assigned by the VP, Clinical Affairs & Training

Clinical Research Engineer

Clinical Specialist

• Train and support organ retrieval and transplant teams in the use of the OrganOx metra according to company policies and procedures
• Provide remote and onsite support while generally being on-call 24/7 for about 15 days per month, including holidays and weekends
• Organize site initiation and refresher visits, training sessions, and centralized training events
• Communicate effectively and promptly with transplant teams, internal management, and coworkers
• Create and write case study reviews with guidance from senior colleagues
• Support managers, directors, and other internal staff with various assignments when not on call
• Participate in R&D activities in laboratory settings under management direction
• Work with liver transplant teams to collect data on perfused and preserved livers for a product performance and usage database
• Attend local, regional, national, and international meetings and conferences as a supporter, participant, or presenter
• Develop and maintain positive working relationships with end users at all levels
• Perform administrative tasks related to expenses, email, and other communications
• Maintain understanding of applicable quality policies and systems
• Follow work and quality procedures to ensure quality-system compliance and high-quality work
• Travel globally, primarily within North America, to leading transplant sites
• Perform other duties assigned by the Director of Clinical Support