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【新着求人情報】 ・・・ MNT-01公開しました。

状況 求人No 資本金 勤務地 スペック 英語力
  MNT-01 10億 外資 東京 Clinical Research Associate (CRA)
管理職候補(Study Leader候補)として、リーダーシップを発揮し、以下の業務をご担当いただける方を求めています
・その他、Japan Clinical Trial Team Memberとしての活動
・治験実務あるいはモニタリング業務経験 3年以上を目安とする
・Global Processに基づく治験実務担当経験
・少なくとも英語での読み書きができる(目安としてTOEIC 650点以上)
  MNT-02 263.49億 外資 東京、大阪 オンコロジー領域 臨床開発モニター
・KOL management能力を有している
  MNT-03 4億 外資 東京 Site Clinical Research Associate
Primary Goals/ Objectives
?Monitors activities conducted by clinical investigative sites as they relate to ** clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity. ?The Site Clinical Research Associate (SCRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring ** studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites. Education
?Bachelor’s Degree required; medical/science/nursing background is preferred.
Background (Experience)
?Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring.
?Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
?Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
?Experience in on-site monitoring of investigational drug or device trials is required.
Required Functional Competencies
?Demonstrated 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.
?Good written and verbal communication skills. Written and verbal fluency in English and local language (if not English).
?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.
?Competence in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications.
?Previous experience with electronic data capture systems is desirable.
?Ability to work independently with minimal supervision.
?The SCRA anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. The 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.
Good written and verbal communication skills. Written and verbal fluency in English and local language (if not English)