OrganOx is hiring a Clinical Research Engineer to play a pivotal role in our clinical research and product development. You will gain an in-depth understanding of our FDA-approved and investigational medical devices and their associated clinical procedures, serving as a key technical and clinical resource.
What You'll Do
- Gain an in-depth knowledge of OrganOx FDA-approved and investigational/research products, as well as associated clinical procedures.
- Serve as the subject matter expert on the device and procedures during IDE studies and research projects.
- Support training of OrganOx employees (e.g., Clinical Specialists) and customers on OrganOx approved, as well as IDE and research products and studies.
- 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 to obtain answers to technical questions.
- Provide clinical and technical feedback on FDA-approved and investigational/research devices to Development and Engineering.
- 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 and 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.
- 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.
Team & Environment
This role reports directly to the VP, Clinical Affairs and Training.
