Clinical Support Specialist (Remote)
Company: Terumo Medical Corporation
Posted on: June 17, 2022
Terumo is an Equal Opportunity Employer
LOCATION: Somerset, New Jersey
Job Title: Clinical Support Specialist -(4 openings)
This is a ground floor opportunity to join our growing Clinical
Affairs team. If you have cath lab, interventional radiology, EP
lab or product development experience combined with clinical trial
experience, please see job description and apply today!
Provide technical, educational, and initial clinical study support
to assist in meeting clinical study and investigator training
objectives. The Clinical Support Specialist will support clinical
investigators who are using Terumo, and / or affiliate subsidiary
products within Terumo funded clinical research programs and will
help in designing and conducting protocol and device training
programs for Terumo studies at clinical sites.
- Support clinical trials at assigned sites including the
responsibility of site management by coordinating all activities
pertaining to qualification and initiation of and ongoing site
support for the clinical trial.
- Provide in-service education and training for physicians,
hospital personnel and office staff on study related documents and
devices in support of Terumo clinical trials.
- Provide occasional training and oversight for study monitors as
well as attending monitoring visits to provide training/support on
device and / or technical expertise on an as needed basis.
- Perform site activities in compliance with GCP and FDA
regulations for clinical trials.
- Provide technical assistance during clinical study procedures
with a focus on Terumo related clinical trial study devices
- Partner with the study team and the study sites to drive study
- Document problems related to investigational devices.
- Submit periodic status reports on all study programs and
- Review and provide feedback on clinical strategy and
- Assist with identifying sites and potential clinical
- Develop clinical site relationships for potential future
- Interface with representatives from key functional groups
including but not limited to R &D, Marketing, Regulatory,
Sales, and International Clinical teams to drive success of
- Develop training programs and modules for training
- Demonstrate a commitment to patient safety and product quality
by maintaining compliance with all TMC Quality Systems
requirements. This includes but is not limited to the prompt
recognition and forwarding of customer complaints (i.e. adverse
events, product performance reports, etc.) to Quality Assurance
(QA), and by ensuring all promotional messaging (i.e. branding
strategies, product claims, etc.) and materials (i.e. literature)
discussed or presented to customers are clinically accurate and
adhere to AdvaMed guidelines and Terumo's policy on Interactions
with Healthcare Professionals. Maintain strong knowledge of and
adherence to regulations regarding promotional material content and
control. Follow procedures for good clinical practices and Design
Control when participating in new product development and clinical
activities. Fully adhere to all applicable FDA regulations,
international guidelines and Terumo's policies at all times.
- Perform other job-related duties as assigned.
- This is a field-based position. Must be able to drive personal
automobile on a daily basis to/from customer accounts and drive
long distances as necessary.
- This position requires approximately 60% overnight travel. In
addition, occasional weekend and international travel is
- Daily entry to hospitals and other medical facilities is
required. Many facilities have instituted vendor credentialing
policies which require vendors to meet defined training, background
check and proof of immunization requirements as a condition of
entry. Terumo Associates entering these facilities are required to
abide by these credentialing requirements.
- Must be able to gain access to and work in the IR suite, cath
lab and operating room. Entry into these areas requires an ability
to wear appropriate gowning, stand for long periods of time, comply
with hospital policy/protocol and be aware of potential biohazards
such as blood borne pathogens.
Knowledge, Skills and Abilities (KSAs)
- Strong clinical knowledge base in anatomy, physiology,
neurovascular, and/or cardiology/interventional terminology
- Ability to develop strong relationships with investigator base
including study coordinators, physicians, and cath lab staff.
- Understanding of, and experience in, U.S. clinical trial
- Strong interpersonal skills to clearly and succinctly
demonstrate products and procedures.
- Ability to make group presentations.
- Ability to interact with Terumo employees, especially R&D,
clinical and marketing, to represent the investigator perspective
on product enhancements and new product development.
- Independent, self-motivated, self-starter.
- Skills in strategic thinking, problem solving, planning and
- Ability to express ideas clearly and succinctly.
- Ability to interpret clinical data.
- Position typically requires a Bachelor's degree in Business,
Engineering or Health sciences.
- Minimum of 5 years' experience in the direct use of or design
of medical devices (e.g., Cath- lab, interventional radiology, EP
lab, product development).
- Minimum of 2-3 years Medical Device or pharmaceutical clinical
trial experience is preferred.
- RCIS, RN or RT certification preferred.
- Prior experience as a Field Clinical Specialist is
Keywords: Terumo Medical Corporation, Portland , Clinical Support Specialist (Remote), Healthcare , Portland, Maine
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