Clinical Affairs Specialist (Temporary - 5 months; anticipated start date of mid-April)

Fujifilm•Bothell, WA

35d•$34 - $40•Hybrid

About The Position

As a temporary Clinical Affairs Specialist, you will use your strong prior planning, communication, and coordination skills to assist in the design, development, and testing of Fujifilm Sonosite’s point-of-care ultrasound systems. Your attention to detail and project planning skills will support the Clinical Engineering team to ensure Fujifilm Sonosite’s products are clinically diagnostic, safe, and meet user needs as you actively participate in a range of research and development activities. As you plan and coordinate complex clinical projects, you will work dynamically with a number of teams and help monitor internal clinical research studies. Success as the Clinical Affairs Specialist is defined as being seen as the coordination expert for internal clinical projects and research studies.

Requirements

3-5 years of complex project coordination required.
Bachelor’s degree or equivalent that thoroughly demonstrates the ability to ideate and coordinate complex projects.
Good Clinical Practice Certification required within 2 months of hire.
Demonstrated ability to work well with internal and external stakeholders.
Exceptional planning and time management skills with a history of accountability and meeting deadlines.
Excellent written and verbal communication skills.
Ability to professionally handle shifting priorities, frequent changes, and stay calm under pressure, especially when coordinating multiple complex projects
Strong PC and system skills, specifically in MS Office.
Strong analytical skills and attention to detail.
Strong desire to expand/grow their knowledge of ultrasound technology, workflows, and medical device development processes.
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.
Ability to become vendor credentialled.

Nice To Haves

Previous medical terminology experience greatly preferred.
Previous knowledge of ultrasound procedures and exams greatly preferred.

Responsibilities

Manage the scheduling and communication of Clinical Engineering’s complex and overlapping projects, ensuring seamless coordination throughout image design and optimization, Live Scan, Engineering Clinical Evaluations, and Clinical Validations.
Serve as the strategic partner to the Manager of Clinical Engineering for team communication, coordination, and alignment.
Responsible for clinical scan room scheduling and ensuring their proper use, coordinating with cross-functional teams for the use and sharing of clinical scan rooms.
Manage and create all Clinical Engineering purchase orders and ensure timely execution and accurate documentation of purchase requests.
Responsible for the day-to-day clear communication and the professional image with external business partnerships and clinical customers.
Accurately track research study consenting and payments to ensure alignment with our approved IRB plans, protocols, and consents.
Monitor Clinical Engineering ways of working and ideate solutions to streamline steps to success.
Prepare and document appropriate paperwork for clinical projects and study sessions such as NDAs, consents, and case report forms.
Audit and document case report forms for clinical studies performed within Clinical Engineering.
Responsible for clinical scan room upkeep, organization, and stocking of supplies.
Assist with the transfer of clinical data from development projects and research studies.
Utilize prior education and knowledge to influence and advance the design and development of FFSS point-of-care ultrasound devices.