Clinical Affairs Specialist||臨床開発スペシャリスト

Company Overview: Company develops medical technology in following areas: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. Product portfolio includes implantable cardioverter defibrillators, pacemakers, electrophysiology catheters, mapping and visualization systems, products for structural heart and vascular diseases, and spinal cord stimulation devices.

Job Contents:




Conducts site monitoring of clinical studies according to Standard Operating Procedures ICH/ISO Guidelines and GCP
Site management responsibility for clinical studies according to Standard Operating Procedures, ICH/ISO guidelines and GCP
Conduct chicken trial, post marketing surveillance and non-regulatory study
Prepare and submit foreign clinical data for Shonin approval


Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance; liaise with vendors; and other duties as assigned

General on-Site Monitoring responsibilities:


Prepare accurate and timely monitoring or contact reports
Perform CRF review, query generation and resolution against established data review guidelinesAssist with the administration of clinical research projects, recruiting investigators collecting investigator documentation and site managaement
Generate and track device shipments and supplies as needed
Track and follow up on serious adverse events as assigned
Assist Senior CRA in managing investigator site budgets
Available for travel including overnight stays as necessary

General Foreign Clinical Data Submission Responsibilities;


Contact clinical team in the US to collect study documents
Write summary of clinical data
Prepare for internal audit and PMDA inspection

Requirements:


Minimum two years of clinical research epxerience including demonstrated competency in site monitoring (including pre-study, initiation, routine monitoring and closeout visits)
In lieu of the above requirements, candidates with two years of site management and/or study coordinator experience may be considered
Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH/ISO guidelines and GCP
Ability to work within a project team
Good planning, organization and problem solving abilities
Good communication skills, oral and written
Works efficiently and effectively in a matrix environment
Fluent in local office language of Japanese and business English proficiency

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