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2024.5.24 [Fri.]

Akihabara UDX 2F AKIBA_SQUARE

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Updated 2024-03-19
Activated 2024-03-19

Clinical Research Specialist

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Staff Level

This posting is managed by:	Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Company Name	Company is not publicly visible
Job Type	Medical/Pharmaceutical/Bio/Fabric/Food - Clinical R & D
Industry	Pharmaceuticals
Location	Asia Japan Tokyo
Job Description	* As a member of trial team, participate in site monitoring activities throughout the course of a trial, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, ICH-GCP and applicable regulations and ensure inspection readiness at all times. Description * Attendance of training for internal CRA appointments * Meetings and appropriate communication with internal and external stakeholders as required for the conduct of the study * Research into the selection of medical institutions * Set-up of clinical sites * Explanation of procedures, including the study protocol, to site personnel (physicians, CRCs, secretariat, laboratory technicians, etc.) * Providing necessary training to medical institution personnel * Preparation and submission of IRB/EC documents required by the implementing medical institution * Consultation and conclusion of contracts with implementing medical institutions * Delivery and confirmation of medicines (including investigational medicines) and materials delivered to the site * Monitoring and facilitation of case enrollment at investigational sites * Conducting SDV and SDR at set frequencies * Appropriate reporting and review of adverse events occurring in study participants * Dissemination of necessary safety information to sites * Ensuring that medicines (including investigational medicinal products) and materials delivered to the site are appropriately managed (and collected if necessary) * Confirmation that site personnel have received the necessary training and understand the regulations and procedures required to conduct the study * Ensuring that the data obtained from the study are entered appropriately in the case report form and that this is confirmed * Appropriate reporting of information obtained from monitoring activities (preparation of monitoring reports and entry into the required tracking systems) * Achieving milestones at your institution, both internally and in collaboration with your institution * Responding to regulatory investigations and internal audits of the implementing medical institution Profile * Ability to carry out monitoring in accordance with GCP * Experience as a CRA in several international trials * Experience in charge of facilities at a university hospital or a core hospital * English proficiency score (TOEIC 730 or above, EIKEN level 2, etc.) * Able to communicate directly in English with overseas vendors, etc. (with no difficulty in reading and writing) Job Offer * Contribute to the effective development of drugs within the speciality care area * Work in global clinical trials as part of Japan and East Asian Hub * Promotion opportunities in Clinical Trial Management area Page Group Japan is acting as an Employment Agency in relation to this vacancy.
Company Info	* World leading multinational pharmaceutical company with broad development pipeline including new drugs, biosimilars and generics.
English Level	Business Conversation Level (TOEIC 735-860)
Japanese Level	Fluent(JLPT Level 1 or N1)
Salary	JPY - Japanese Yen JPY 6000K - JPY 8000K

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