Clinical Research Associate(CRAⅠ~Principal)
グローバルCRO
想定年収
380万円 ~ 950万円
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。
募集人数
1人
応募条件
技能/経験
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(TOEIC600点相当)
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 . 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 . 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 -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
※TOEIC/TOEFL/CASEC等のスコアをお持ちでしたら記載お願い致します
※面接前までで構いません、英文レジメのご提出をお願い致します
学歴
大学
職務経験
要 (2年以上)
業界経験
要
年齢
年齢制限不問
英語力
初級以上
その他語学力
語学力詳細
ー
勤務条件
雇用形態
無期雇用
試用期間
有り(6か月)
給与
年俸制
年収:380万円 ~ 950万円
月収:31万円~79万円
月額基本給:31万円~79万円
年俸を12分割で支給
賞与・インセンティブ
年0回
昇給
有り 年1回 / 3月
勤務地
大阪府 東京都
就業時間
09:00~18:00
休憩時間:60分
残業:月0時間~20時間程度
就業時間 09:00 ~ 18:00
休憩時間 60分
残業 月0~10時間程度
フレックス制
残業手当
通常の残業代
通勤手当
交通費:全額支給((上限11万/月))
休日・休暇
完全週休二日制, 年末年始
年間休日:120
年間有給休暇:初年度 11日 1か月目から
【休日・休暇詳細】
※管理職の場合は初年度有給14日
※年末は12/29-1/3まで休み
社会保険
雇用保険, 健康保険, 労災保険, 厚生年金
求人No.:NJB2015063
最終更新日:2026/6/3
