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Form of workTerumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
Remote based - anywhere in US.
Provide technical, educational, and initial clinical study support to assist in meeting clinical study and investigator training objectives. The Sr. 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.
- Department Level
- Assist in department level initiatives involving the development of SOPs, Tracking Systems, and create best practices and standards of excellence for Clinical Support initiatives within TMC and other Terumo Entities.
- Assist as needed to review and provide feedback on clinical strategies, assist with CSS budget forecasts and planning.
- Assist in the development of training programs and modules to support global commercialization efforts of internal / external sales team, and/or physician / staff training initiatives.
- Support pre-clinical, pre-market, and post approval initiatives as needed.
- Study Level
- Assist the clinical project team in identifying potential clinical investigators for clinical trials.
- Responsible to review and provide feedback on study specific strategies and developing clinical study documents (eg Protocols, Investigational Brochure, Information for Use, etc)
- Responsible to support clinical trials, the assigned internal study management teams, and external clinical sites by:
- o Assisting with the collection of key study documents;
- o Attending Site Qualification and Site Initiation Visits to demonstrate the investigational device, procedural requirements, and reviewing protocol eligibility with physicians and their clinical research staff.
- o On-going training on the investigational device, procedural requirements, and protocol eligibility with investigational staff through case support and study related meetings throughout the duration of the clinical study.
- Accountable and responsible as Study Lead to develop and maintain the study specific the Clinical Support Specialist (CSS) and Physician Training and Certification programs for investigational devices for assigned clinical studies.
- Accountable and responsible as Study Lead to develop and maintain study specific Clinical Support Plans (CSP) and to secure compliance to all aspects of the CSP across all team members for assigned studies.
- Accountable and responsible as Study Lead and CSS for periodic status reports on all assigned clinical studies.
- Accountable and responsible as Study Lead and CSS to complete Product Performance Reports (PPR) and support internal device evaluations initiatives.
- Collaborate with Clinical, Quality, Engineering, Regulatory, Marketing, R&D, and New Product Development global teams to review device performance observations, support VOC, and work with our Quality Assurance teams to review device risk profile and other related inputs to device performances and/or end-user feedback.
- Site Level
- Responsible and assist team members in developing site-specific recruitment tools, tracking patient screening and enrollment metrics, attending and supporting investigational procedures, and collaborating with Clinical Research Associate team members on all aspects of the clinical study.
- Independently develop and implement site specific in-services and education plans for investigational devices for assigned site and study staff members.
- Perform site activities in compliance with ICH/GCP, internal policies and procedures, Protocol, CSP, and FDA regulations for clinical trials.
- Develop strong working relationships with assigned clinical research staff members to support clinical research trials / initiatives.
- Provide technical assistance during clinical study procedures with Terumo products
- Partner with the study team and the study sites to drive study enrollments and compliance to protocol, ICH/GCP, Local, Regional, and Federal requirements.
- 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 Terumos 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 Terumos policies at all times.
- Perform other 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 70% regional and global overnight travel. In addition, occasional weekend and international travel is required.
- 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.
- 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 processes.
- 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 time-management.
- Ability to express ideas clearly and succinctly.
- Ability to interpret clinical data.
- Bachelors degree in Biology, Chemistry, Sports Medicine, Nursing, Engineering, or Health Sciences field required, Advanced degree preferred; or equivalent combination of education, training and experience.
- Minimum 10 years combined experience in supporting Clinical Research Studies and/or the direct use of, support of, or design of medical devices (e.g., Cath Lab, Interventional Radiology, EP lab, Product Development) required.
- Minimum of 2 years experience supporting a Peripheral and/or Cardiovascular Medical Device clinical trials strongly preferred.
- Minimum of 3 years scrub experience within a Cath Lab or Interventional Radiology environment required.
- Minimum of 2 years experience in a lead role on a clinical trial and/or project team; strongly preferred.
- Technical or professional health services licensure from an accrediting licensing entity (e.g., RCIS, RN, RT) strongly preferred.
Knowledge of Terumo Interventional System Product portfolio preferred.
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.
