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