Position Summary The Clinical Research Engineer is responsible for: - Gaining an in-depth knowledge of OrganOx FDA approved and investigational or research products, as well as associated clinical procedures - Serving as the subject matter expert on the device and procedures during IDE studies and research projects - Supporting training of OrganOx employees (e.g. Clinical Specialists) and customers on OrganOx approved, as well as IDE and research products and studies Major Responsibilities Under direction from the VP, Clinical Affairs and Training, the Clinical Research Enginer will be responsible for: ***Product Knowledge and Training*** · Gaining an in-depth knowledge of OrganOx FDA approved and investigational/research products, as well as associated clinical procedures - Support the development of training and other support materials for FDA approved and investigational/research devices and procedures - Train investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures - Attend cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center - Interface with Development and Engineering in order to obtain answers to technical questions - Provide clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering ***Clinical Studies*** - Serve as a resource to investigational/research centers, as well as OrganOx personnel, regarding investigational/research devices and clinical study protocols - Support the development of clinical study protocols - Support sound and thorough data collection ensure data analysis in accordance with the protocol - Develop training and other support materials for clinical protocols, study procedures, data collection and review - Assist in the development and implementation of a study-specific database for clinical studies - Assist Clinical Research Associates with review of study data - Support writing and review of clinical study reports and the clinical portion of FDA submissions - Identify and report study protocol challenges and compliance issues to clinical management ***Management support*** - Support OrganOx in maintaining current and developing professional relationships with investigators and investigational/research sites - Serve as a resource to clinical management for departmental decisions related to continuing quality improvement of process and procedures - Other duties as assigned by VP, Clinical Affairs & Training