Overview:

The Clinical Field Specialist delivers clinical education at study sites, as well as training and support to physicians, research staff, and hospital personnel during surgical study cases in the United States. The Clinical Field Specialist also plans activities to support recruitment at the sites. This role serves as the primary clinical expert on-site, ensuring that all activities are conducted in accordance with Good Clinical Practice (GCP), local regulations, and company standards. The Clinical Field Specialist plays a key role in ensuring that studies are conducted according to the clinical study protocol, resulting in the successful execution of multiple clinical studies while safeguarding data integrity and patient safety.

Key Responsibilities:

• Provides surgeons, research staff and hospital staff with clear instructions on the study protocol.
• Anticipate causes of protocol deviations and act to prevent them and intervene in the O.R. if necessary.
• An ability to keep up to date with scientific literature.
• A high level of emotional intelligence to work effectively with stakeholders.
• The ability to understand, process, communicate, and present scientific information to a high standard.
• External customer focus with strong networking capabilities and integration with KOLs.
• Ability to work independently without immediate supervision (if remote)
• Perform other related activities as assigned.
• Meet all requirements and maintain credentialing status to access operating rooms in various hospitals across the country.
• Support recruitment with visits outside surgeries, and clarify questions around patient eligibility.
• Clinical support of study sites.
• Ability to work in multiple studies with different protocols (≥ 3 Post-Market Studies with a minimum of 7 sites each) and adapt priorities according to business and strategic needs.
• Review and complete surgical check list.
• Ability to remain in the Operating Room for prolonged periods.
• Collaborate the developing and updating of study surgical forms and education programs.
• Training of site personnel, identifying study related issues and escalating as needed.
• Ensure the study case is in compliance with clinical protocol.
• Identify, address and/or escalate study related risks, issues, mitigations, and opportunities for improvements.
• Engage with Key Opinion Leaders (KOLs) in the fields of medicine or research.
• Stay informed on the latest scientific research and clinical data relevant to Kuros Biosciences.
• Ability to travel weekly (as needed).

Qualifications:

• Education:
  • Bachelor's Degree in a life sciences field, (science related discipline preferred).
• Experience:
  • Minimum 2 years of experience in the medical device industry and in educating surgeons, research staff and hospital staff in clinic and during surgical procedures in the operating room.
  • Prior experience in an orthopedic and neurosurgical (spine) surgery environment, operating room, or orthopedics and spinal neurosurgery clinic is highly preferred.
  • Clinical research experience, specifically supporting medical device clinical trials
  • The highest ethical standards, specifically surrounding protected medical information and clinical research.
  • Organize, manage, and facilitate clinical workshops at study sites to educate Principal Investigators and the broader research team on study protocols.
  • Working knowledge of relevant clinical regulations and industry standards including Good Clinical Research Practice, ICH, ISO, FDA and the MedTech EU Code of Practice.
  • Exceptional presentation and education skills, with a demonstrated ability to train and influence physicians and medical staff.
  • Ability to work outside of standard business hours to accommodate surgical schedules and study needs.

• Skills:
  • Networking skills and the confidence to interact with senior experts and orthopedic and neurological surgeons.
  • Teamwork skills and an ability to work effectively in a cross-functional setting with a variety of colleagues.
  • Ability to travel in accordance with company travel policy.
  • Organized, detail oriented, exceptional ability to manage timelines and deadlines.
  • Excellent communication and presentation skills.

Travel Requirement:

• Up to 70% of travel