Clinical Research Engineer

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

The Clinical Research Engineer is responsible for:

- Gaining an in-depth knowledge of OrganOx’s 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’s 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’s 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’s personnel, regarding investigational/research devices and clinical study protocols

• Support the development of clinical study protocols

• Support sound and thorough data collection to 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 & 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 matrixed 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

·       Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Requirements

The Clinical Research Engineer should/will have:

• Minimum 3 years of experience as a Certified Clinical Perfusionist (CCP)

• Bachelor’s degree in Cardiovascular Perfusion or other health profession, science, or engineering field with a strong technical and clinical background; Master’s 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

• Must able to travel up to 50% of the time within North America as required and reside within one hour of a major airport hub to facilitate trav