Clinical Specialist

Jenscare Scientific Co., Ltd.; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Jenscare Innovation is building a US and international clinical team to advance a breakthrough transcatheter heart valve technology. The role supports a fast-paced, cross-border environment with trials in the US, California, and Europe.

The candidate will work in a small team, travel domestically up to ~70%, and contribute to clinical protocols, investigator brochures, CRFs, and study reports while ensuring compliant documentation and quality outcomes.

Qualifications

• Bachelor’s degree (or equivalent) in Life Sciences, Nursing Licensure or Pharmacy required.
• Minimum of 3+ years clinical experience in devices/structural heart environments preferred.
• Experience with aseptic procedures and SOPs/GCP/ICH guidelines.

Responsibilities

• Provide case support to clinical cases.
• Collaborate with hospital teams to prepare space and setup for device preparation.
• Set up device preparation space in aseptic environments and operating suites.
• Coordinate devices and accessories with hospital staff in aseptic manner.
• Load/Prepare valve, delivery system, and accessories per SOPs and training.
• Guide physicians in proper use and setup of valve and delivery system.
• Document case data to meet internal and external requirements.
• Coordinate training and development for Clinical Operations team.
• Act as SME on valve preparation/loading and contribute to protocols.

Skills

Clinical trials knowledge

Good Clinical Practices (GCP)

Interpersonal skills

MS Office proficiency

Analytical problem-solving

Self-starter and team player

Strong written/verbal communication

Detail-oriented

Ability to travel ~70%

Education

Bachelor’s degree in Life Sciences, Nursing or Pharmacy

Tools

MS Office Suite

Job description

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.