Location: Remote (U.S. based, near major airport hub)
Travel: Up to 75%
Description
FIRE1 is seeking a skilled and passionate Field Clinical Specialist to support U.S. clinical sites participating in an Investigational Device Exemption (IDE) study in interventional cardiology. This field-based, remote position is essential to the successful execution of clinical research by providing on-site procedural support, site training, monitoring, and management.
Responsibilities
- Provide on-site clinical support for implantation procedures during the FIRE1 IDE study.
- Assist in identifying, qualifying, and initiating research sites and investigators.
- Serve as a trusted expert on device technology and procedural guidance for physicians, research staff, and internal teams.
- Conduct site monitoring visits (selection, initiation, monitoring, close-out) in compliance with Good Clinical Practice (GCP) and regulatory standards.
- Maintain thorough and timely documentation of site activities and monitoring outcomes.
- Build and sustain professional relationships with clinical investigators and site personnel to ensure high-quality study execution.
- Utilize expertise in cardiac imaging and echocardiography to support study data integrity.
- Lead technical briefings and data discussions with clinical site teams.
- Collaborate effectively with CROs and independent contractors involved in study execution.
- Proactively track and manage study activities to identify and resolve issues promptly.
- Monitor site performance and address study issues proactively and efficiently.
- Ensure documentation supports Trial Master File (TMF) compliance and that investigator files meet GCP and regulatory requirements.
- Support the development of technical documents and key scientific publications.
- Engage with FIRE1’s Quality Management System (QMS) to support quality objectives and regulatory compliance.
Qualifications
- Bachelor’s degree in Engineering, Biological Sciences, Nursing, or a related healthcare field.
- Minimum 2 years of experience in a similar role within the medical device industry supporting invasive procedures.
- Strong background in interventional cardiology or related field
- Comfortable in the cath lab or procedural environment; a passion for working in high-impact, fast-paced clinical environments.
- Willing and able to travel frequently (up to 75%)
- Strong attention to detail with excellent analytical and problem-solving skills; able to accurately collect, interpret, and present clinical and technical data.
- Excellent written and verbal communication skills with the ability to interact effectively at all organizational levels.
- Confident communicator and problem solver, able to thrive in dynamic field settings with the ability to interact effectively at all organizational levels.
- Strong organizational and time management skills.
- Solid understanding of implantable devices, medical imaging, cardiovascular anatomy and physiology, and heart failure.
- Proficient in Microsoft Word, Excel, and PowerPoint.
Location: We are hiring for two field-based, remote positions. Preference will be given to candidates located on the East Coast or in the Midwest, but we are open to other locations based on experience. Candidates must reside near a major U.S. airport hub and be available to travel frequently on short notice.
Benefits:
- Medical
- Dental
- 401k
- Vacation/Holidays