Clinical Research Engineer

OrganOx•Atlanta, GA

28d•Onsite

About The Position

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

Requirements

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
Experience with perfusion devices and management of patients or donor organs is a must
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
Previous experience in the medical device industry with preference for transplant and perfusion devices is desired

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