Clinical Research Associate

募集要項

• こだわり条件

  設立50年以上 語学（英語）を生かす 年間休日120日以上 土日祝日休み

• 仕事内容

  ■Main Tasks:
  ・ Serves as the primary point of contact for assigned clinical research sites.
  ・ Performs site development and training （supporting and coaching site personnel） site set up site monitoring （evaluation of site performance and identification of issues） and site close out activities for assigned clinical research sites with designated program SOPs Client expectations clinical study protocols and GCPs.
  ・ Problem solves （including CAPA development where necessary） identified issues with appropriate escalation to Clinical Study Manager and/or Clinical Director.
  ・ Assures protection of the rights safety and well being of subjects study integrity and data quality.
  ・ Leads/supports temporary CRO CRA（s） if applicable.
  ・ Performs activities such as but not limited to source data verification case report form review AE/SAE review and reconciliation device accountability questionnaire reconciliation equipment maintenance supplies tracking and query resolution.
  ・ Facilitates the collection and maintenance of regulatory and site documentation for the Trial Master File and site file.
  ・ Manages IRB/EC/CRB submissions including; workflow submission through approval and reporting of safety information and may prepare answers as required to the IRB/EC/CRB in conjunction with study team/site staff as applicable.
  ・ Maintains awareness of site dynamics and able to motivate persuade and educate site staff.
  ・ Complies with the Clinical Monitoring Plan and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the studies within the program.
  ・ Completes monitoring reports in compliance with requirements in the Clinical Monitoring Plan.
  ・ Exhibits ability to proactively identify and interpret problems recommend creative solutions and influence appropriate changes.
  ・ May support more than one clinical study.
  ・ Complies with all objectives and metrics related to study and program execution.
  ・ Attend meetings as requested （i.e. i…

• 職種分類

  素材・化学・食品・メディカル系技術者 ＞ 医療・医薬・メディカル系技術者 ＞ 研究・開発（医療・医薬・メディカル）

• 業種分類

  医療・ヘルスケア・介護機器

• 応募条件

  【必須条件】
  ・Minimum 3 years’ experience in clinical study implementation at medical device/pharmaceutical/biotechnology industry or at CRO for CRA. Over 5 years’ experience for Sr. CRA. Experience in lead monitor is preferred.

• 年収

  600万円～1000万円
  600万円 - 1000万円

• ポジション

  メンバー

• 雇用形態

  正社員

• 勤務地

  東京都

• 勤務時間

  09:00 ～ 17:30

• 休日・休暇

  【有給休暇】10
  【休日】完全週休二日制
  土
  日
  祝日
  夏季休暇
  年末年始
  有給は入社月によって付与日数が異なります。詳細はオファー時に通知いたします

• 福利厚生

  【通勤手当】全額支給
  【社会保険】健康保険
  厚生年金
  雇用保険
  労災保険
  

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