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

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募集要項

会社概要

同社は医薬品の開発過程を支援する各種の受託事業をおこなう日系企業です。医薬品の臨床試験データの収集・分析、薬事申請の支援、品質管理などの業務を担当しています。専門家チームがお客様のニーズに合わせたソリューションを提供し、安全性と有効性の確保に努めています。同社は、厳格な規制に準拠し、高品質なサービスを提供することに注力しています。お客様の医薬品開発の成功をサポートするために、経験と知識を活かしたプロフェッショナルなサポートを提供しています。

業務内容

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

応募条件

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)

給与

400 - 1000 万円

勤務地

大阪