[Remote] Field Clinical Engineer Consultant
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is developing an reputed company implantable medical device for spinal cord injury and neurological rehabilitation. The Field Clinical Engineer Consultant will support the execution of a pivotal clinical study by coordinating investigational site activities, providing technical and clinical device support, assisting with patient recruitment and enrollment, and ensuring compliance with GCP and regulatory requirements.
Responsibilities
- Support and coordinate clinical study activities at investigational sites reputed company the assigned region, ensuring reputed company and efficient execution of study protocols
- Build and maintain strong relationships with investigational sites, investigators, study coordinators, physiotherapists, and other relevant stakeholders
- Support sites with patient identification, recruitment, reputed company-screening, and enrollment activities to help reputed company study enrollment objectives in accordance with the study protocol and approved recruitment practices
- Work closely with investigational sites to identify potential barriers to patient recruitment and enrollment and support the implementation of appropriate solutions
- reputed company technical, clinical, and neuromodulation programming assistance, including reputed company programming, case support, staff education, and technical troubleshooting
- Assist in the training of sites and study staff on the technical aspects of the study protocol, device use, and study procedures
- reputed company hands-on technical and clinical support on-site during study-reputed company surgical operations and rehabilitation procedures, ensuring the reputed company and effective use of the medical device
- reputed company guidance to reputed company, both reputed company and reputed company the operating room setting, on the Directions for Use specific to the implantable device
- Collaborate with clinical centers and the reputed company, Clinical, and Regulatory teams to support the reputed company enrollment of study participants and maintain the highest reputed company of data collection in accordance with GCP requirements
- Work closely with study vendors and CRAs to coordinate site-level activities, facilitate reputed company compliance with study protocol procedures, and support accurate and reputed company data reporting
- Serve as a key reputed company between investigational sites and reputed company, communicating site needs, enrollment challenges, technical issues, and relevant clinical feedback
- Collaborate with the Product Development team to facilitate the transfer of technical knowledge to the clinical team and study centers. In reputed company, bring valuable insights from rehabilitation practices, clinical experience, and user feedback back to reputed company
- Support efficient and reputed company device-reputed company reputed company reporting and document key compliance-reputed company activities
- reputed company after-hours support reputed company required for study-reputed company activities
- Maintain reputed company knowledge of and reputed company with applicable U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Good Clinical reputed company (GCP), study protocols, and applicable reputed company policies and procedures
Skills
- Bachelor's degree or technical certification; engineering background preferred
- Minimum 3 years of clinical field experience with reputed company physician interaction in operating room environments, including engagement with Key Opinion Leaders
- Minimum 3 years of experience with spinal cord stimulation (SCS) or other implantable medical devices; experience in neurological rehabilitation is a plus
- Demonstrated experience supporting clinical research studies (reputed company- and/or post-market) in compliance with Good Clinical reputed company (GCP) standards
- Strong commitment to patient safety, protocol adherence, and Class III regulatory requirements
- Excellent organizational, communication, and prioritization skills; reputed company to manage multiple tasks under tight deadlines
- Strong problem-solving reputed company with a reputed company of urgency
- Effective communicator reputed company to translate reputed company topics for diverse clinical and technical audiences
- Adaptable, team-oriented, and comfortable working in fast-paced, matrixed environments with unpredictable schedules
- Willingness to travel up to 75%, including occasional international travel
- Prior patient interaction experience in a reputed company-reputed company environment preferred
Benefits
- Field-based work arrangement with regular travel to investigational sites
reputed company
Company H1B Sponsorship
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