Clinical Support Specialist (Remote)
Terumo is an Equal Opportunity EmployerLOCATION: Somerset, New JerseyJob Title: Clinical Support Specialist 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!Job Summary: Provide technical, educational, and initial clinical study support to assist in meeting clinical study and investigator training objectives. The Clinical Support Specialist I 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. Job Details:Study LevelAssist the clinical project team in identifying potential clinical investigators for clinical trials. Assist to review and provide feedback on study specific strategies and developing clinical study documents (eg Protocols, Investigational Brochure, Information for Use, etc)Assist to support clinical trials, the assigned internal study management teams, and external clinical sites by: Assisting with the collection of key study documents;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.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. Assist Study Lead and CSS for periodic status reports on all assigned clinical studies.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 LevelResponsible 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. 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 productsPartner 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 (ie adverse events, product performance reports, etc.) to Quality Assurance (QA), and by ensuring all promotional messaging (ie branding strategies, product claims, etc.) and materials (ie 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 duties as assigned. Working Conditions: 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% 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. Position Requirements:Knowledge, Skills and Abilities (KSAs) Strong clinical knowledge base in anatomy, physiology, neurovascular, and/or cardiology/interventional terminologyAbility to develop strong relationships with investigator base including study coordinators, physicians, and cath lab staff.Understanding of, and experience in, US 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. Background ExperienceBachelor's degree required, Biology, Chemistry, Sports Medicine, Nursing, Engineering, or Health Sciences field strongly preferred or equivalent combination of education, training and experience. Minimum 3 years' combined experience in supporting Clinical Research Studies and/or the direct use of, support of, or design of medical devices (eg, Cath Lab, Interventional Radiology, EP lab, Product Development) required.Minimum of 3 years' scrub experience within a Cath Lab or Interventional Radiology environment required. Technical or professional health services licensure from an accrediting licensing entity (eg, RCIS, RN, RT) strongly preferred. Knowledge of Terumo Interventional System Product portfolio preferred.