Role Summary
The Clinical Research Engineer acts as a key technical and clinical liaison during investigational device exemption (IDE) studies and research initiatives. With deep knowledge of both approved and investigational medical devices and associated procedures, this position ensures accurate implementation of study protocols and supports the advancement of product development through real-world clinical insights.
Key Responsibilities
- Develop comprehensive understanding of OrganOx’s FDA-cleared and research-stage devices, including their clinical applications and operational workflows
- Act as primary technical and procedural expert during clinical investigations, providing on-site and remote support at research centers
- Train internal teams, including Clinical Specialists, as well as external partners on device use, study protocols, and data collection standards
- Collaborate with engineering departments to relay clinical feedback and support resolution of technical inquiries
- Contribute to the creation and refinement of training materials, study documentation, and support resources
- Support development of clinical study protocols and ensure adherence to regulatory requirements
- Assist in building and validating study-specific databases to support accurate data capture
- Review clinical data for completeness and consistency, supporting data analysis efforts
- Provide input into clinical study reports and regulatory submissions related to device performance
- Identify and escalate protocol deviations or compliance concerns to clinical leadership
- Support continuous improvement initiatives within clinical operations through feedback and process evaluation
- Work closely with investigators and research sites to maintain strong, professional relationships
- Advise clinical management on technical and procedural matters impacting study quality and efficiency
- Perform additional duties as directed by the Vice President of Clinical Affairs & Training
