Clinical Field Specialist

Kuros Biosciences · United States · 1 wk ago

RemoteRemoteManagementFull-time

About the Role

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. 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.

This is an exciting opportunity for a motivated self-starter to join a fast-growing, highly collaborative team. This remote position is open to candidates located within 60 miles of a major airport in the Central Region of the United States and requires up to 70% travel throughout California, Utah, Arizona, Ohio, Illinois, Colorado, and Pennsylvania.

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; intervene in the O.R. if necessary.
Stay up to date with scientific literature.
Demonstrate a high level of emotional intelligence to work effectively with stakeholders.
Understand, process, communicate, and present scientific information to a high standard.
Maintain an external customer focus with strong networking capabilities and integration with Key Opinion Leaders (KOLs).
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.
Provide clinical support of study sites.
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 checklists.
Remain in the Operating Room for prolonged periods.
Collaborate in developing and updating study surgical forms and education programs.
Train site personnel, identify study-related issues, and escalate as needed.
Ensure the study case is in compliance with the 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.
Travel weekly as needed (up to 70%).

Requirements

Bachelor's Degree in a life sciences field (science-related discipline preferred).
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, with an exceptional ability to manage timelines and deadlines.
Excellent communication and presentation skills.

Physical Requirements and Work Conditions

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Mobility & Posture: May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.
Lifting/Carrying: May require lifting and carrying items 50 pounds or more, depending on the role.
Manual Dexterity: Frequent use of hands and fingers for typing, writing, grasping, and operating office or job-specific equipment.
Driving: Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver’s license. Specific requirements may vary by role.