Senior Site Clinical Research Associate(シニアCRA)

求人会社名 : 医療用医薬品の研究、開発、製造、輸出入、販売 

求人ID : 23774-121

  • エージェント取り扱い求人
  • 中途入社5割以上
  • 外資系
  • 土日祝日休み
  • フレックスタイム制
  • 住宅補助制度
  • 資格取得支援制度
  • 語学(英語)を生かす
  • 育休・産休・介護休暇実績あり


仕事内容 ・Monitors activities conducted by clinical investigative sites as they relate to our clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.
・The Senior Site Clinical Research Associate (Sr.SCRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring our studies are conducted according to all applicable regulations and business processes.
・Ensures regulatory inspection readiness at assigned clinical sites. May be responsible for assignments of greater complexity than the Clinical Research Associate (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues).
・Additionally, the Sr. SCRA may train and provide guidance to junior staff.

・Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
・Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and our Standard Operating Procedures (SOPs) and business processes.
・Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
・Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues, than those assigned to SCRAs.
・Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.
・Facilitates Quality Assurance Audit processes as indicated.
応募資格 【求める学歴】
・Bachelor’s Degree required; medical/science/nursing background is preferred.

・Minimum of 3 years of clinical related experience, with a minimum of 2 years as clinical research monitor.
・Experience in on-site monitoring of investigational drug in multi-therapeutic areas desired.
・Working knowledge and experience with electronic data capture systems and clinical trials management systems.

・Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
・Excellent knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
・Proven strong site management and monitoring skills
・Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
・Strong ability to work independently in a geographic region with minimal supervision.
・The Sr SCRA anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. The Sr SCRA should use functional expertise and exercise good judgment in seeking appropriate guidance and ensures that follow-up to any and all corrective action is taken at the clinical site and is properly documented.

・Excellent written and verbal communication skills. Written and verbal fluency in English and local language (if not English).

・Proficiency in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications

・Acute observational skills, analytical and conceptual capabilities.
・Exhibits high degree of flexibility when facing changes in the work environment.
・Attention to detail and strong interpersonal skills.
勤務地 東京本社
勤務時間 8:45~17:30
年収・給与 700万円以上 1000万円以下

 年 収:年俸制、昇給年1回 (採用ポジションにより年収パターンあり)
 賞 与:年3回
 手 当:住宅手当、通勤手当(全額)
待遇 各種社会保険等完備、退職金、団体生命保険、定期健康診断、自己啓発支援制度、社員持株会、財形貯蓄、医療費補助制度、永年勤続表彰制度、福利厚生プログラム、自動車通勤不可、TOEIC受験料補助 
休日・休暇 完全週休2日制、年間休日125日
雇用形態 正社員  
募集背景 増員
採用希望時期、選考プロセス 【採用希望時期】ASAP


求人会社名 医療用医薬品の研究、開発、製造、輸出入、販売 
従業員数 約650名
概要 医療用医薬品の研究、開発、製造、輸出入、販売


業種 食品・医薬品・化粧品

Senior Site Clinical Research Associate(シニアCRA)


株式会社A・ヒューマン (本社)



脇 裕美子 (ワキユミコ)

コンサルタント歴 : 11年

  • メディカル
  • 外資系企業


外資製薬会社でのSenior Site Clinical Research Associate(シニアCRA)の募集です!