Location: Tokyo, Tokyo JP Randstad Sourceright

Job Number:

External Description:

JOB TITLE: Clical Resarch Specialiset
DEPARTMENT: Clinical Research and Medical Science   Clinical Solutions  Study Monitoring
REPORTING TO: Clinical Research Manager

**********************************************************************************************

職務内容

募集職種: 臨床研究スペシャリスト(モニター職)

勤務地と勤務形態:

  • 勤務地: 東京 (ただし、担当施設の対象は全国)
  • 勤務形態: 出勤と在宅勤務のハイブリッド (募集開始時点の最低出勤回数:1回/月。今後増える可能性あり)

雇用形態: 正社員

仕事内容:

  • 治験、市販後臨床研究および市販後調査の計画・実施・進捗管理と報告書作成
  • 担当施設における手続き業務、モニタリングならびに監査対応
  • 関連文書の作成および確認
  • 内部・外部関係者との良好な関係構築
  • 重篤有害事象や逸脱の報告と対応
  • 医療機器の不具合報告と対応
  • その他、組織やプロジェクトに必要な業務

応募資格: 

<必須要件>

  • 大学卒業以上(医学、薬学、看護学、生命科学、工学関連分野が望ましい)
  • 医療機器会社、製薬会社、またはCROでの5年以上の治験モニター経験
  • 大学病院等の基幹病院の担当経験
  • GCPに関する深い知識
  • 高いコンプライアンス意識と品質意識
  • 優れたコミュニケーション能力と問題解決スキル
  • 自発的に考え能動的に行動できる能力
  • チームワークを重視し、協力して業務を遂行できる能力
  • 積極的に学び続ける姿勢
  • 以下に支障がないこと:
    • 重篤有害事象発生等への迅速な対応や突発的な外勤
    • グローバル会議への早朝あるいは夜間参加
    • 宿泊を伴う出張
    • 英語でのSOPや業務関連文書の読解、モニタリング報告書作成

<歓迎要件>

  • 循環器や心臓血管領域の担当経験
  • ISO 14155の知識
  • チームリーダーの経験
  • 新人やジュニアモニターの育成経験

給与: 当社規定に従って支給

昇給および賞与: 1回/年、会社業績および本人の業績評価をもとに支給

選考プロセス: 書類選考、対面またはリモートによる面接(2-3回)

Job Number:

Community / Marketing Title:
Clinical Research Specialist【 CRA 】

Location_formattedLocationLong:
Tokyo, Tokyo JP



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