Clinical Research Engineer Jobs

Do you want to grow your career with an innovative, fast-paced and rapidly growing medical device company? OrganOx is committed to developing products that save lives by making every donated organ count. Our dynamic team strive to achieve excellence in the field of organ transplantation and you could be part of our exciting journey.

About OrganOx Limited

OrganOx Limited was founded in 2008 to exploit normothermic preservation technology invented by Prof Peter Friend and Prof Constantin Coussios at the University of Oxford. Since that time the core technology has been developed into the OrganOx metra, a revolutionary device for storing livers at normal body temperature for extended periods of time. Following extensive pre-clinical and clinical studies, the product is now commercially available within the EU and US.

The metra device has been used in ca. 2,000 liver transplants to date and OrganOx is in a period of significant growth as the clinical potential of the metra is realized worldwide.

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

Responsibilities may include the following and other duties may be assigned:

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

Skills and Experience

· Demonstrate aptitude in and knowledge of relevant therapeutic areas and ability to learn and integrate new/different therapeutic areas

· Experience in a clinical setting and clinical studies is beneficial

· Knowledge of project management tools and practices

· Proven ability to work in a matrix organization

· Ability to work independently and as a part of a team

· Have an analytic approach to problem solving

· Excellent presentation and computer skills

· Strong communicator, capable of effectively presenting ideas and concepts

· Excellent organizational skills and attention to detail

Qualifications

The Clinical Research Engineer should/will have:

· Certified Clinical Perfusionist degree strongly preferred

· Other possible degrees: Bachelor’s degree in other health profession, science, or engineering field with a strong technical and clinical background. Masters degree preferred.

· 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

WHAT WE OFFER

Our team is dynamic and motivated as we strive to achieve excellence in the field of organ transplantation. We seek to recruit and retain the best people from a broad range of backgrounds who share our values of innovation, evidence, integrity, teamwork, respect and passion. We offer competitive compensation and excellent benefits packages to our employees in an effort to safeguard your health, to ensure your work-life balance, and to provide you with ongoing financial stability.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.