Clinical Specialist - Poland
Role Overview
The Clinical Specialist (Console Operator) is responsible for the technical preparation, verification, and operation of the Vibe System during clinical study procedures, as well as device inventory management. The role is strictly limited to predefined technical functions and does not include any clinical responsibilities, patient interaction, or study endpoint assessments.
Key Responsibilities
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Device preparation & verification
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Perform catheter inspection and pre-use functional testing prior to each procedure, in accordance with IFU and study procedures
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Verify readiness of the Vibe System (console, catheter, cables, and accessories) prior to treatment
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Ensure all system checks and connections are completed per protocol and device manuals
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Console operation (during procedure)
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Operate the Vibe Console strictly according to pre-specified protocol-defined treatment parameters
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Execute predefined technical steps for treatment delivery, including system activation and monitoring
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Monitor console indicators and ensure proper device performance throughout the procedure
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Perform troubleshooting only within predefined, protocol-approved steps (e.g., device fault handling)
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Role boundaries & blinding
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Perform only predefined technical functions with no involvement in clinical decision-making, patient management, or safety/efficacy assessments
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Maintain no interaction with the study subject and no participation in clinical procedures
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Operate independently from the clinical team (e.g., positioned behind a curtain during procedures)
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Serve as the unblinded console operator, with access to treatment assignment solely for device operation
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Maintain strict confidentiality of treatment allocation and must not disclose treatment assignment to investigators, site staff, or subjects
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Not involved in data collection, endpoint evaluation, or study assessments
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Post procedure activities
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Ensure proper shutdown, cleaning, and storage of the console in accordance with device requirements
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Document device operation and any technical issues or deviations
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Ensure appropriate handling of used catheters per study procedures
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Inventory & logistics management
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Manage on-site device inventory (consoles, catheters, accessories)
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Track device usage, serial/lot numbers, and stock levels
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Coordinate shipment, storage, and accountability of investigational devices
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Qualifications
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Clinical, technical, or biomedical background
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Experience operating medical devices in clinical or research settings
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Experience with maintaining aseptic/sterile conditions during the procedure
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Strong attention to detail and documentation practices