Clinical Research Engineer

OrganOx Limited

Atlanta (GA)

On-site

USD 90,000 - 130,000

Full time

14 days+

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Benefits offered by this job

Health coverage

Dental coverage

Vision coverage

Disability coverage

401(k) retirement plan

Job summary

OrganOx Limited seeks a Clinical Research Engineer to become a subject matter expert on OrganOx devices, support IDE and research projects, and assist in training staff and customers on clinical procedures. The candidate will engage with clinical study protocols and data collection.

Role includes collaboration with Development and Engineering, and regular travel within North America to sites and centers conducting studies.

Qualifications

Demonstrated knowledge of therapeutic areas and clinical procedures.
Experience in a clinical setting and with clinical studies is beneficial.
Familiarity with project management tools and practices.
Ability to work in a matrix organization and manage multiple priorities.
Strong written and verbal communication, with attention to detail.

Responsibilities

Gain in-depth knowledge of OrganOx FDA approved and investigational devices and procedures.
Serve as subject matter expert during IDE studies and research projects.
Support training of OrganOx staff and customers on devices and studies.
Provide clinical and technical feedback to Development and Engineering.
Support development of clinical study protocols and data collection.
Assist in the creation and management of study-specific databases and reports.
Travel regularly within North America as required.

Skills

Analytical thinking

Clinical communication

Problem solving

Project management

Team collaboration

Independent work

Presentation skills

Computer literacy

Attention to detail

Education

Certified Clinical Perfusionist

Bachelor's in health science or engineering

Master's degree (preferred)

Tools

Word

Excel

PowerPoint

Job description

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

Product Knowledge and Training

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 & 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