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求人情報詳細

Clinical Research Associate(CRAⅠ~Principal)

求人番号
NJB2015063
採用企業名
非公開
職種

メディカル・バイオ - 臨床開発モニター

雇用形態
無期雇用
勤務地
大阪府 東京都
仕事内容

被験者の権利が保護されていること、および試験の実施が現在承認されているプロトコル(GCP)に準拠していることの確認。
適用される規制要件 Sponsor Standard Operating Procedures(SOPs)に従って、資格認定、調査の開始、定期的なモニタリング、および調査サイトへの訪問の実施。
サイトのコンプライアンス確保、医師および施設スタッフとの連携の中心となって試験の実施管理。

 Verify that the rights and well-being of subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents, and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), GCP, and applicable regulatory requirement(s);
 Ensure site compliance while conducting qualification, study initiation, routine monitoring, and study site close-out visits for research sites according to Medpace/Sponsor Standard Operating Procedures (SOPs);
 Serve as the primary resource to the clinical investigator and site staff;
 Maintain close collaboration, interaction, and effective working relationships with Medpace internal cross-functional teams;
 Ensure quality completion of visit reports, follow-up letters, and maintenance of study-related databases and ClinTrak ® Monitoring Portal; and
 Must have and maintain a valid driver’s license and the ability to drive to monitoring sites. This specifically applies in the US, Canada, any countries where cars/car allowance are provided by Medpace, and other countries dependent on monitoring travel and patterns as designated by Medpace.


■休日:完全週休二日制, 年末年始

求める経験
年齢制限の理由

CRA経験2年以上
メールでのコミュニケーションができる英語力
4年制大学卒以上
グローバル試験経験者
セルフスターター

<Clinical Research Associate - Experienced I>
Bachelor's degree +2 years of clinical monitoring experience or earlier if the below
competencies/achievements are demonstrated (considerations will be given to advanced/relevant
degree and prior industry experience):
 Broad knowledge of the field of clinical research;
 Satisfies essential functions of an independent CRA which is demonstrated by the number of
months resourced and number of independent on-site visits performed*;
 May act as a Lead CRA (dependent upon performance and experience);
 Demonstrated ability to maintain desired report accuracy and metrics;
 Adequate feedback from site audits/inspections and CRA on-site/remote evaluation;
 Uses interpersonal skills in order to communicate and manage relationship with sponsors, sites,
and internal associates; and
 Work effectively and independently from home-based office, if permitted.
*Remote monitoring and/or serving as a co-monitor on more complex (specialty) project
assignments will be taken into consideration on a case-by-case basis.

<Clinical Research Associate - Experienced II>
Bachelor's degree +3 years of clinical monitoring experience or 1.5 years from Medpace level-
Experienced I. The below competencies/achievements should be demonstrated:
 Comprehensive knowledge of practices and procedures relating to all clinical monitoring visit
types, including practical application of this knowledge;
 Demonstrated ability to act as a Lead CRA (as applicable);
 Act as a resource for new CRAs and ability to facilitate training and serve as a mentor for
new CRAs; and
 Implements new ideas/solutions, without prompting, within their authority.

<Clinical Research Associate - Senior>
Bachelor's degree +5 years of clinical monitoring experience or 2 years from Medpace level-
Experienced II. The below competencies/achievements should be demonstrated:
 Demonstrated ability to independently function as a Lead CRA (on more complex studies as
applicable), including the ability to effectively plan, delegate, and review the work of others;
 Demonstrated ability to present at meetings, including the ability to seek, make, and develop
suggestions; and
 Knowledgeable enough about Clinical Monitoring practices and procedures to represent the
function in internal and external (e.g., business development) meetings .

<Clinical Research Associate - Principal>
Bachelor's degree +10 years of clinical monitoring experience or 5 years from Medpace level -Senior
or Master's degree +8 years of clinical monitoring experience or approximately 3 years from
Medpace level-Senior. The below competencies/achievements should be demonstrated:
 Demonstrated ability to problem solve and organize work within cross -functional teams.
 Has an advanced knowledge of clinical monitoring practices and procedures and can
leverage this knowledge to guide business operations and operational development


■職種未経験者:不可

年収
380万円 - 900万円
語学力
英語力:初級以上
受動喫煙対策
就業場所 全面禁煙
受動喫煙対策詳細

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