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Clinical Research Specialist
* 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.
Client Details
* World leading multinational pharmaceutical company with broad development pipeline including new drugs, biosimilars and generics.
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.
Client Details
* World leading multinational pharmaceutical company with broad development pipeline including new drugs, biosimilars and generics.
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.
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