Clinical Research Associate (RE-33904455)

Location: Tokyo, Japan    |  Remote Working Available
Salary: competitive
Job Type: Permanent
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【Primary Role & Responsibility】

・Conduct site feasibility and pre-trial assessment activities

・Prepare IRB submissions and investigational site contracts

・Conduct Site Initiation Activities where all relevant training will be given including, but not limited to; the protocol and protocol procedures, the information and consent process, SAE reporting, sample processing and shipment and drug handling and accounting.

・Conduct Site Monitoring Activities according to monitoring plan including, but not limited to; drug supplies, site compliance with protocol and all current and relevant regulations, conducting source data review and verification, ensuring all serious adverse events (SAEs) have been reported appropriately

・Review the study file periodically to ensure compliance with relevant SOPs and regulations, guidelines and policies and ICH GCP

・Monitor patient recruitment timelines at sites

・Conduct ongoing CRF discrepancy resolution

・Monitor study drug requirement at sites when additional supplies need to be shipped to the site

・Monitor SAE reporting by the site

・Conduct Site Close-out activities

・Share study team about monitoring issues including significant quality events

・Document all study site visits including selection, initiation, monitoring and close-out visits as required/ Send follow-up letter to site

【Must-Have】

・Bachelor's Degree

・5+ years' working experience as CRA

​・Experience working in the research and development of pharmaceutical industry

・Experience working for global study

・Clinical & regulatory processes Thorough understanding of good clinical practices (GCP)

・Thorough understanding of key operational elements of clinical research (e.g., site selection, monitoring, data acquisition and cleaning, reporting, etc)

・Presentation, influencing and Communication skills Ability to develop and deliver presentations

・Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.

【Nice-to-Have】

・Master's degree

・Experience in early drug development, early phase oncology study

・Coaching junior CRAs

Real is part of the larger SThree K.K group

To find out more about Real, please visit www.realstaffing.com | Real についてもっと詳しく知りたい方はこちらへ→ www.realstaffing.com

Award winner of:

Great Place to Work 2019 | Growth Company of the Year by TALint Recruitment Awards 2019 | Best Healthcare & Life Sciences Recruitment Company of the Year by Recruitment International Awards 2018

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