Clinical Research Associate(Japan)の求人情報なら転職エージェントJAC

求人情報

Clinical Research Associate(Japan)

  • 週休二日制
  • 外資
求人番号

NJB1053082

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会社名 社名非公開 <業種:メディカル・バイオ - CRO>
職種

メディカル・バイオ-臨床開発モニター

雇用形態 正社員(期間の定めなし)
勤務地 大阪府 東京都
仕事内容

・ Perform site feasibility, site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work, good clinical practice and other applicable regulations

・ Serve as a primary point of contact with investigative sites

・ Prepare patient recruitment and retention strategy, manage payments and conduct other site management activities in coordination with Clinical Trial Manager (CTM) or Project Manager (PM)

・ Conduct monitoring visits and site management for a variety of protocols, sites and therapeutic areas.

・ Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

・ Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.

・ Escalate quality issues to PM/CTM, Line Manager and/or QA as necessary.

・ Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, electronic/case report form (e/CRF) completion and submission, and data query generation and resolution.

・ Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation (e.g. TMF, ISF, etc).

・ Assist in the preparation, maintenance, and submission of regulatory and clinical documents including but not limited to CTNs, clinical trial materials, manuals, monitoring plans, CMC documents, Ethics Committee documents, and other regulatory dossiers/binders in collaboration with other departments

・ Conduct site conduct negotiations and track site budget and payment

・ Participate in site/ sponsor audit and inspections

・ May provide assistance to less experienced clinical staff as necessary

・ Participate in internal and external meetings (such as Investigator Meetings, etc.) as necessary

・ Other tasks as deemed necessary by the line manager


■休日:祝日 日 土 完全週休二日制

求める経験、能力
年齢制限の理由

・Familiaiy with clinical operations

・Strong communication skills(Japanese essential,English considered a plus)

・1+years monitoring /CRA experience storongly preferred


■職種未経験者:不可

年収 400万円 - 600万円
語学力
英語力: 
上級
語学: 
日本語

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