Clinical Research Engineer

This is a fully remote position, open to applicants in Ohio, +2 more states.

📋 Description

• Acquire comprehensive knowledge of OrganOx FDA-approved and investigational/research products along with related clinical procedures.

• Act as the subject matter expert on devices and procedures throughout IDE studies and research initiatives.

• Facilitate training for OrganOx employees and customers concerning approved, IDE, and research products and studies.

• Assist in developing training and support materials for devices, procedures, and clinical protocols.

• Provide training to investigational/research centers, Clinical Specialists, and OrganOx staff.

• Participate in cases involving investigational/research devices, serving as a technical and clinical resource.

• Collaborate with Development and Engineering teams on technical inquiries.

• Offer clinical and technical insights to Development and Engineering teams.

• Assist investigational/research centers and OrganOx personnel with devices and clinical study protocols.

• Contribute to the development of clinical study protocols.

• Aid in meticulous data collection and protocol-compliant data analysis.

• Create materials for clinical protocols, study procedures, data collection, and review.

• Help in the development and implementation of study-specific clinical databases.

• Support Clinical Research Associates in reviewing study data.

• Assist in writing and reviewing clinical study reports and the clinical sections of FDA submissions.

• Identify and communicate protocol challenges and compliance issues to clinical management.

• Cultivate and maintain professional relationships with investigators and research sites.

• Assist clinical management with decisions related to departmental quality improvement.

• Perform other tasks as assigned by the VP of Clinical Affairs & Training.

⛳️ Requirements

• Demonstrate capability and knowledge in relevant therapeutic areas, with the ability to learn and adapt to new or different therapeutic areas.

• Experience within a clinical environment and involvement in clinical studies is advantageous.

• Familiarity with project management tools and practices is essential.

• Proven ability to function effectively in a matrix organization.

• Ability to work both independently and collaboratively within a team.

• Analytical mindset for problem-solving.

• Exceptional presentation and computer skills.

• Strong communication abilities, adept at effectively conveying ideas and concepts.

• Excellent organizational skills with a keen attention to detail.

• Certification as a Clinical Perfusionist is strongly preferred.

• Bachelor’s degree in a health profession, science, or engineering with a solid technical and clinical foundation.

• A Master’s degree is preferred.

• Mandatory experience with perfusion devices and managing patients or donor organs.

• Previous experience in the medical device field, particularly with transplant and perfusion devices, is desirable.

• Proficiency in computer applications, including Word, Excel, and PowerPoint.

• Willingness to travel regularly within North America as required.

• Eligibility to work in the USA.

• Possession of a valid driver’s license.

🏝️ Benefits

• Health insurance

• Dental insurance

• Vision insurance

• Disability coverage

• Flexible spending accounts

• 401(k) retirement plan with company matching after 90 days

• Paid time off

• Holidays

• Additional leave benefits

• Employee discounts

• Access to onsite wellness facility

• Support for work-life balance

• Ongoing professional development opportunities