Join us as we build a clinical team to support a new and exciting breakthrough technology in the cardiovascular space. Jenscare Innovation is a global company advancing a new transcatheter heart valve in the US, and we are actively recruiting to put together the right clinical team.
This is an opportunity help create and work with a US and international team to advance a technology, with trials in the US, CA, and Europe. The desired candidate will enjoy working in small teams, be flexible, and enjoy a fast paced and exciting environment.
Key Responsibilities
- Provide case support to clinical cases-
- Work with hospital team to identify and prepare the proper space and setup for device preparation.
- Set up device preparation space in aseptic environment and operating suite.
- Coordinate all devices and accessories and work with hospital staff to manage and prepare devices in aseptic manner.
- Load/Prepare valve, delivery system, and accessories according to documented procedures and training. Work and guide supporting Clinical Specialist partner to properly load/prepare the valve and accessories.
- Guide physicians in the proper use and setup of the valve and delivery system with the supporting stabilizer.
- Guide physicians in the proper use of the valve and delivery system to achieve a successful case result.
- Work with hospital staff to properly document the required case documentation to meet internal and external requirements
- Work with Clinical field and Clinical Operations team to ensure proper devices are available and provided to the site prior to start of case.
- Ensure proper documentation is completed in compliant with SOPs, GCP, US/EU regulatory/clinical guidelines.
- Work with Clinical Operations and Clinical Field team to support training activities. Development/coordination of training for the Clinical Operations team. Ensure training occurs as needed for the study team, investigational sites, and vendors.
- Act as a subject matter expert to team members on valve preparation and loading.
- Provides input into Clinical Protocols, Investigator's Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs).
- Build and maintain case timelines, track milestones, monitor overall operational performance metrics.
Required Qualifications
- Education: Bachelor’s degree (or equivalent) in Life Sciences, Nursing Licensure or Pharmacy, at minimum.
- Minimum of 3+ years of clinical experience with an understanding of devices, structural heart preferred, and the clinical and aseptic environment.
- Experience and understanding of startup environment a plus.
- Experience with aseptic procedures.
- Applicable SOPs, GCP, US/EU regulatory/clinical guidelines.
- Hospital credentials a plus.
- Strong knowledge of Good Clinical Practices and ICH guidelines and their application to the conduct of clinical trials.
- Proficiency in clinical studies.
- Strong analytical and problem‑solving skills.
- Must be a demonstrated self‑starter and team player with strong interpersonal skills.
- Excellent written/verbal skills and computer skills (MS Office Suite).
- Strong attention to detail.
- Strong organizational skills; ability to manage multiple priorities.
- Experience in medical devices required, structural heart trials strongly preferred.
- Willing and able to travel domestically, anticipated to be ~70% of work time.