RemoteRemote role with regular travel to investigational sites; travel up to 75%, including occasional international travel.
Biology & BiotechClinical Research Operations
About the job
Requirements
A bachelor's degree or technical certification is required; an engineering background is preferred.
At least 3 years of clinical field experience with direct physician interaction in operating room environments, including engagement with Key Opinion Leaders.
At least 3 years of experience with spinal cord stimulation or other implantable medical devices.
Experience supporting clinical research studies, pre-market or post-market, in compliance with Good Clinical Practice standards.
Commitment to patient safety, protocol adherence, and Class III regulatory requirements.
Organizational, communication, and prioritization skills, including the ability to manage multiple tasks under tight deadlines.
Problem-solving ability and a sense of urgency.
Ability to communicate complex topics to diverse clinical and technical audiences.
Ability to adapt, work as part of a team, and operate in fast-paced, matrixed environments with unpredictable schedules.
Willingness to travel up to 75%, including occasional international travel.
Responsibilities
Support and coordinate clinical study activities at investigational sites within the assigned region to ensure efficient execution of study protocols.
Build and maintain relationships with investigational sites, investigators, study coordinators, physiotherapists, and other stakeholders.
Support patient identification, recruitment, pre-screening, and enrollment in accordance with the study protocol and approved recruitment practices.
Work with investigational sites to identify barriers to patient recruitment and enrollment and support appropriate solutions.
Provide technical, clinical, and neuromodulation programming assistance, including complex programming, case support, staff education, and technical troubleshooting.
Assist in training sites and study staff on study protocol technical aspects, device use, and study procedures.
Provide on-site hands-on technical and clinical support during study-related surgical operations and rehabilitation procedures to ensure safe and effective device use.
Guide healthcare professionals, in and outside the operating room, on the Directions for Use specific to the implantable device.
Collaborate with clinical centers and the Clinical and Regulatory teams to support timely participant enrollment and high-quality data collection in accordance with Good Clinical Practice requirements.
Coordinate site-level activities with study vendors and clinical research associates, facilitate timely compliance with study procedures, and support accurate and timely data reporting.
Communicate site needs, enrollment challenges, technical issues, and clinical feedback between investigational sites and the company.
Collaborate with Product Development to transfer technical knowledge to the clinical team and study centers, and relay insights from rehabilitation practices, clinical experience, and user feedback to the company.
Support timely device-related quality reporting and document compliance-related activities.
Provide after-hours support when required for study-related activities.
Maintain current knowledge of and comply with applicable U.S. Food and Drug Administration regulations, other regulatory requirements, Good Clinical Practice, study protocols, and company policies and procedures.
Desired Qualifications
Engineering background.
Experience in neurological rehabilitation.
Prior patient interaction experience in a healthcare-related environment.
As a Field Clinical Engineer, you will play a pivotal role in supporting the on-site execution of our first pivotal clinical study for our active implantable medical device, collaborating closely with hospital staff, including physiotherapists, and various study partners. Acting as the crucial link between healthcare facilities and our company, you will enhance our understanding of SCI and neurological rehabilitation practices. Your primary responsibilities include building and maintaining strong relationships with investigational sites, providing comprehensive technical and clinical support, supporting patient identification, recruitment, pre-screening, and enrollment activities, and ensuring the highest level of compliance and adherence to Good Clinical Practice (GCP) standards.
Responsibilities
Support and coordinate clinical study activities at investigational sites within the assigned region, ensuring seamless 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, pre-screening, and enrollment activities to help achieve 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.
Provide technical, clinical, and neuromodulation programming assistance, including complex 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.
Provide hands-on technical and clinical support on-site during study-related surgical operations and rehabilitation procedures, ensuring the safe and effective use of the medical device.
Provide guidance to healthcare professionals, both within and outside the operating room setting, on the Directions for Use specific to the implantable device.
Collaborate with clinical centers and the ONWARD Medical, Clinical, and Regulatory teams to support the timely enrollment of study participants and maintain the highest quality of data collection in accordance with GCP requirements.
Work closely with study vendors and CRAs to coordinate site-level activities, facilitate timely compliance with study protocol procedures, and support accurate and timely data reporting.
Serve as a key link between investigational sites and ONWARD, 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 return, bring valuable insights from rehabilitation practices, clinical experience, and user feedback back to the company.
Support efficient and timely device-related Quality reporting and document key compliance-related activities.
Provide after-hours support when required for study-related activities.
Maintain current knowledge of and comply with applicable U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Good Clinical Practice (GCP), study protocols, and applicable ONWARD policies and procedures.
Experience, Qualifications & Skills:
Bachelor’s degree or technical certification; engineering background preferred.
Minimum 3 years of clinical field experience with direct 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.
Prior patient interaction experience in a healthcare-related environment preferred.
Demonstrated experience supporting clinical research studies (pre- and/or post-market) in compliance with Good Clinical Practice (GCP) standards.
Strong commitment to patient safety, protocol adherence, and Class III regulatory requirements.
Excellent organizational, communication, and prioritization skills; able to manage multiple tasks under tight deadlines.
Strong problem-solving mindset with a sense of urgency.
Effective communicator able to translate complex 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.
Supervision Individual Contributor reporting to our Senior Director Clinical Operations.
Location Field-based, with regular travel to investigational sites.