Job Summary: 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. Job Details: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 devicesPartner with the study team and the study sites to drive study enrollments.Document problems related to investigational devices.Submit periodic status reports on all study programs and activities.Review and provide feedback on clinical strategy and protocols.Assist with identifying sites and potential clinical investigators.Develop clinical site relationships for potential future use.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 clinical programs.Develop training programs and modules for training purposes.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. 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 60% 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.Job Summary: Job Details: Working Conditions:
QualificationsKnowledge, Skills and Abilities (KSAs) Background Experience
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