Fractyl Health, Inc.
Job Title: Field Clinical Specialist
Job Number: 30341
Location: Lexington, MA
Clinical Specialists will bring strong clinical expertise on the Revita System and Revita duodenal mucosal resurfacing (DMR) Procedure and work closely with advanced endoscopists, nurses and other related clinical technicians. They will assume the primary role as clinical experts for the company’s clinical studies. They will conduct clinical education and training for advanced endoscopists involved with the clinical studies. Applying in-depth knowledge, they will support healthcare professionals with product information, training, and procedural support. There are 2 slots for this position available in separate regions: NY/NJ and the midwest.
- As the clinical expert for the Revita System, advise investigators and other health care providers on device usage, provide user training and serve as the primary resource for clinical support and device-troubleshooting in assigned territories.
- Directly assist clinical study investigators and other healthcare professionals in the optimal use of the Revita System before, during, and after clinical cases.
- Ensure safe and proper preparation and usage of the product and bring about procedural success.
- Support clinical trial through a variety of presentations, and hands-on demonstrations including, but not limited to, procedural training, clinical in-service on technologies, and product issue resolution.
- Ensure timely collection and reporting of all required medical documentation pertaining to the medical device operation and clinical procedures/cases.
- Contribute to developing training materials and other tools.
- Provide complex clinical problem-solving to investigators and other internal functional departments.
- Effectively manage relationships with clinical sites, fostering highly effective relationships with physicians, physician assistants, nurses, other clinical/medical staff and internal staff.
- Proactively solve complex and unique clinical and technical problems related to the medical device and procedure.
- Build strong relationships with endoscopists and other endoscopy team members to encourage professional engagement with clinical programs.
- Perform some technical field service procedures on the Revita System as necessary.
- Participate in national meetings, conventions, and other related events as appropriate and assigned.
- Support other Medical Affairs and Clinical Development clinical and medical initiatives, as needed.
- Perform all activities in compliance with applicable regulations, Fractyl’ s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
- Bring a “can do” spirit to work and deliver on other responsibilities as assigned.
Education or Certification Requirements
- Bachelor's degree in Nursing, Science, Biomedical Engineering, or equivalent
Professional Work Experience
- 6+ years of hands-on work experience as a Clinical Specialist or other related areas
- Direct experience in a hospital-setting with Gastroenterology and/or Endoscopy focus.
- Applicable experience in biotech, pharmaceutical and/or medical device industries preferred.
- Applicable experience in technology, automotive, aerospace and/or military industries is a plus for certain positions.
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Qualifications and Skills
- Strong knowledge of medical devices, pharmaceutical and biological clinical Phase I-IV trials, etc.
- Strong knowledge of clinical setting with prior direct experience navigating a hospital setting.
- Strong knowledge and skills related to medical device product demonstration.
- Proficient in computer applications including Microsoft Word, Excel, and PowerPoint.
- Strong prioritization and planning skills.
- Strong presentation skills, inclusive of delivery to large and small groups in a clinical setting.
- Track record of successful budget and expense management skills.
Other Essentials and Key Success Factors
- Successful track record of working in high-growth and dynamic organizations
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
- Highest levels of professionalism, confidence, personal values, and ethical standards
Additional Position Requirements:
- Travel up to 75% of time within assigned territories
- Ability to lift up to 25 lbs.