临床研究工程师

ABOUT ORGANOX:
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.
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
Under direction from the VP, Clinical Affairs and Training, the Clinical Research Enginer will be responsible for:
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

Requirements
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 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
A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate.
Benefits
We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development.
Originally posted on Himalayas