ジョブNo.654882 Senior Clinical Research Associate

  • 正社員
  • 外資系企業
  • 従業員1000名以上
  • 年間休日120日以上
  • 女性が活躍
  • フレックスタイム

非公開

Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site in order to verify that:

The rights and well-being of human subjects are protected.
The reported trial data are accurate, complete, and verifiable from source documents.
The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s).

【Key Responsibilities】
• Acting as the main line of communication between the sponsor and the investigator.
• Communicate with Japan Study Leader and third party vendors as needed.
• Conduct site selection activities for verifying adequate qualifications.
• Manage and monitor the responsible sites and ensure their quality appropriately, agreed cost spent and on a timely basis by conducting the followings;

Manage the contracts of clinical trial with the responsible site and ensure the compliance with regulations and company-wide governance controls such as Ethical Interactions policy or company-legal standard.
Input appropriate information in order to create clinical trial related documents (ex. CSP, IND).
Ensure a steady implementation of supplying clinical site with study materials.
Provide investigators and site staff with education and training regarding study specific procedures including EDC system.
Manage the patient recruitment status and request acceleration of patient recruitment for Investigators and site staff.
Conduct source data verification and ensure data quality to collect appropriate clinical study data.
If necessary, support sites to ensure sites understand and resolve data queries in a timely manner.
Ensure that essential documents and source data are appropriately stored in a clinical site.
Produce monitoring activity reports appropriately and in a timely manner.
Confirm and ensure status of GCP/ICH guidelines, CSP and policy compliance.
Report critical and/or serious issues relating to site management to the study team and line manager in a timely manner.

• Ensure input the latest site related information in IMPACT at appropriate timing.
• Participate in-house and/or external clinical trial related meeting (ex. Study team meeting, CRA’s meeting, Investigators’ meeting) including the preparations.
• Cooperate with site audit in liaison with QA and a site inspection by regulatory authority.
• Cooperate with resolving the result of SAE reconciliation.
• Ensure inspection ready TMF regarding site related documents.
In addition to above, Senior CRA also is to
• Lead a certain number of CRAs (incl. CRO CRAs) to in terms of information management and communication related to site management in study team to keep monitoring quality.
• Taking some tasks delegated by Study Leaders if agreed.
• Contribute to the development of Clinical Operations Japan by joining some projects or initiatives, e.g. Process Ownership responsibilities, CRA training.
• Mentor CRAs on monitoring and internal procedures.

ワークライフバランスの良さや、社内(国内外)での豊富なキャリアパスが用意されている点が特徴のグローバル企業です。

コンサルタント 成田 卓

募集要項

職種 メディカル系/CRA(臨床開発モニター)
年収 600万円~900万円
勤務地 大阪府、東京都
応募資格 <必須>
・CRAとしての経験3年以上
・社内外のステークホルダーとの円滑なコミュニケーション能力
学歴 大卒以上(理系学部)
雇用形態 正社員(期間の定めなし)
勤務時間 09:00-17:15
[実働時間] 7時間15分
内勤:フレックスタイム制有
休日・休暇土、日、祝日
年間休日 125日
夏季休暇、年末年始休暇、育児休暇、介護休暇、慶弔休暇
慶弔、赴任、リフレッシュ他
待遇・福利厚生社宅、従業員持株制度、財形貯蓄、その他待遇・福利厚生
【諸制度】社宅制度、厚生年金基金、退職年金、財形貯蓄、融資制度、持株会制度、慶弔見舞金、マルティプル・エンプロイメントシステム、AZストックボーナス、ほか 【その他】リスクベネフィット(特別弔慰金、入院見舞金及び治療給付金、災害補償) 退職金
健康保険、厚生年金、労災、雇用保険
通勤交通費(全額)、残業代(全額)、営業手当、住宅手当

企業情報

企業名非公開
業種・資本 メーカー系(医薬品(メーカー))
ヘッドオフィス:海外

Senior Clinical Research Associate

  • メディカル系/CRA(臨床開発モニター)
  • 600万円~900万円
  • 大阪府、東京都