Clinical Research Engineer

Summary

OrganOx is a commercial-stage organ technology company developing technologies to improve outcomes for patients with acute or chronic organ failure. The Clinical Research Engineer serves as a subject matter expert on OrganOx devices and associated clinical procedures, supports training, and contributes to clinical studies, data collection, regulatory submissions, and clinical operations.

Responsibilities

• 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
• 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
• 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
• 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

Skills

• Other possible degrees: Bachelor's degree in other health profession, science, or engineering field with a strong technical and clinical background
• Experience with perfusion devices and management of patients or donor organs is a must
• Previous experience in the medical device industry with preference for transplant and perfusion devices is desired
• Computer literate and familiar with Word, Excel, and PowerPoint
• Be able to travel regularly within North America as required
• Right to work in the USA
• Have a full driver's license
• Certified Clinical Perfusionist degree strongly preferred
• Masters degree preferred

Qualifications

Must Haves

• Other possible degrees: Bachelor's degree in other health profession, science, or engineering field with a strong technical and clinical background
• Experience with perfusion devices and management of patients or donor organs is a must
• Previous experience in the medical device industry with preference for transplant and perfusion devices is desired
• Computer literate and familiar with Word, Excel, and PowerPoint
• Be able to travel regularly within North America as required
• Right to work in the USA
• Have a full driver's license

Nice to Haves

• Certified Clinical Perfusionist degree strongly preferred
• Masters degree preferred

Benefits

• Health coverage available from day one
• Dental coverage available from day one
• Vision coverage available from day one
• Disability coverage available from day one
• Flexible spending accounts available from day one
• 401(k) retirement plan with company matching after 90 days
• Paid time off
• Paid holidays
• Additional leave benefits
• Employee discounts
• Access to an onsite wellness facility
• Opportunities for ongoing professional development
• Remote work arrangement