[Osaka] Experienced CRA (including Sr./Pri.)

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Job details

Company overview

Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development.

Responsibilities

Work to confirm (monitor) whether clinical trials are conducted in accordance with relevant laws and regulations (GCP) and implementation plans (protocols) at appropriate medical institutions under consignment from clients, and whether the human rights and safety of subjects are protected is. 

• Selection of medical institutions and doctors in charge of conducting clinical trials
• Confirmation of clinical trial schedule and contract details, and implementation of briefing sessions for medical institution staff
• Clinical trial progress management: Progress management of the number of cases, collection / inspection of case report reports, collation of case report reports with materials
• Delivery of investigational drug, confirmation of supply management status, collection
• Preparation of monitoring report
• Clinical trial completion procedure, confirmation work

Requirements

Educational Background:

• Science vocational school, junior college, university graduate, graduate school graduate or above

Language:

• Japanese: Native
• English - Conversation

• Consistent monitoring experience from clinical trial facility selection to completion procedures at pharmaceutical manufacturers and CROs (experience in global trials is a plus)
• Communication skills, negotiation skills, coordination skills
• Educational experience for new / young CRA
• Experience with CTMS
• Work experience in English (Reading / Writing)

Salary

4 - 10 million yen

Location

Osaka