As the AI Enablement Specialist, you will use your experience and expertise to further Fujifilm Sonosite research efforts by managing projects that enable research and AI development. This position will work closely with the AI teams to identify, track, and execute the needs of our AI and other development work. This includes close coordination with Product Management, Clinical Engineering, Design, Regulatory, Legal and other members of the development team. You will manage the plans, protocols, contracts, relationships, and agreements for AI research projects.  You will use your research coordination skills, curiosity, and industry best practices to ensure Fujifilm Sonosite research is conducted efficiently and in alignment with all applicable regulatory guidelines and requirements. You will conduct research site monitoring and audits to ensure that plans and protocols are followed as specified and all research training and credentialing is complete. Achieving success in this position will mean being recognized as the in-house specialist for advancing AI initiatives through our research and development processes.

*** Hybrid Role *** 

FUJIFILM Sonosite, Inc. is the innovator and world leader in bedside and point-of-care ultrasound, and an industry leader in ultra-high frequency micro-ultrasound technology. Headquartered near Seattle, the company is represented by a global distribution network in over 100 countries. Sonosite’s portable, compact systems are expanding the use of ultrasound across the clinical spectrum by cost-effectively bringing high-performance ultrasound to the point of patient care. For more information, please visit www.sonosite.com.

FUJIFILM Corporation is a subsidiary of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of “giving our world more smiles,” we address social challenges and create a positive impact on society through our products, services, and business operations. Under its medium-term management plan, VISION2030, which ends in FY2030, we aspire to continue our evolution into a company that creates value and smiles for various stakeholders as a collection of global leading businesses and achieve a global revenue of 4 trillion yen (29 billion USD at an exchange rate of 140 JPY/USD). For more information, please visit: www.fujifilmholdings.com.

For further details about our commitment to sustainability and Fujifilm’s Sustainable Value Plan 2030, click here.

Essential Job Functions:

• Collaborate with AI and development team members to identify the data collection and development needs of Fujifilm Sonosite.
• Manage a global network of AI data collection and development contracts and agreements.
• Drive and record decision making and create plans, protocols, contracts, and agreements that are aligned with our development needs.
• Estimate and track AI data collection timelines and budgets, communicating risks and needs as they arise.
• Lead data labeling efforts with clear plans, management, execution, and reporting.
• Collaborate closely with regulatory, legal, and compliance teams to ensure alignment with all applicable regulatory requirements and laws.
• Manage clinical research sponsorship with external study sites.
• Monitor research studies to ensure compliance with research protocols and policies.
• Communicate with all necessary stakeholders to ensure all development needs are represented within procedures and agreements.
• Collaborate closely with the Clinical Engineers and Clinical Affairs Specialist for research study planning, expectations, and coordination.
• Oversee internal IRB submissions and conduct protocol and informed consent updates.
• Responsible for the study start-up processes including the development of project budgets, negotiations, feasibility checklists, and planning.
• Responsible for the creation and maintenance of clinical research protocols, policies, agreements, and contracts.

Knowledge and Experience:

• Minimum of 3-5 years of experience in managing AI research projects including data collection and site management.
• Bachelor's degree in business, finance, or a related healthcare/engineering field or a combination of work history and education..
• Strong knowledge of clinical research processes and procedures required.
• Thorough knowledge and experience with IRB submissions and HIPAA required.
• Previous medical device industry or clinical trial experience required (3-5 years).
• Previous healthcare experience desired (ARDMS, RDCS, RN, etc.)
• Equivalent education/experience may be considered to substitute for minimum qualifications.
• Knowledge of applicable research requirements, guidelines, and state and federal laws required.
• Good Clinical Practice Certification or equivalent required or ability to complete within 1 month of hire.

Skills/Abilities:

• Demonstrated history of excellent organizational skills, attention to detail, and strong communication skills.
• Excellent communication and technical writing skills.
• Excellent ability to establish and enhance strong relationships with external and internal stakeholders.
• Strong PC and analytical skills.
• Effective planning and time management skills with a history of accountability and meeting deadlines.
• Ability to work independently as well as part of a cross-functional team in a fast-paced environment.
• Ability to travel up to 20% of the time.
• Hybrid role: In-office attendance required 60-100% of the time, as project schedules allow.
• Ability to lift 25lbs with or without accommodations.

Salary and Benefits:

• $80,000.00 - $105,000.00 depending on experience + variable bonus opportunity (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range).  
• Insurance:
  • Medical, Dental & Vision
  • Life & Company paid Disability
• Retirement Plan (401k):
  • 4% automatic Company contribution
  • Fujifilm matches 50 cents for every dollar you contribute, up to 6% of your salary
• Paid Time Off:
  • You can accrue up to three (3) weeks of PTO in your first year of employment
  • PTO increases based on years of service
• Employee Choice Holidays:
  • Four (4) additional paid days off, based on date of hire in the calendar year
• Paid Holidays:
  • Eight (8) paid holidays per year

FUJIFILM Sonosite offers a fantastic compensation package, including benefits, and a 401k program.  Visit us today to learn more about our exciting technologies and how you can make a difference.  To apply and obtain further details regarding key responsibilities and experience requirements, check out our careers page at www.Sonosite.com/about/careers.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (ffss-hr@fujifilm.com or (425) 951-1200).