Clinical Research Associate / 臨床開発モニター
想定年収
600万円 ~ 1,000万円
勤務地
大阪府 東京都
従業員数
30名(2026年2月)
仕事内容
As a CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets. You will have the opportunity to work on clinical studies in various therapeutic areas and indications while maintaining the highest quality standards in the industry. This function operates at site and country level and can be assigned to projects as monitor or lead monitor.
Join the PSI team and help drive innovation and excellence in advancing healthcare solutions.
You will:
Prepare, conduct and reports site selection, initiation, routine monitoring and close-out visits
Perform CRF review, source document verification and query resolution
Be responsible for site communication and management
Act as a communication point between project teams and the site
Leads project team calls on a country level
Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
Participate in feasibility research
Support regulatory team in preparing documents for study submissions
Prepare and participate in site audits and inspections
CRAとして、モニタリングおよび施設マネジメントの様々な業務を遂行し、正確で規制要件に従ったデータを確保し、被験者の権利と安全を確保します。さまざまな治療領域および適応症の臨床試験に取り組む機会があり、業界最高レベルの品質基準を維持します。PSI チームに参加し、ヘルスケアソリューションの革新と卓越性を推進してください。
▪ 施設選定、契約手続き、モニタリング、終了手続き、及び報告書の作成
▪ CRF レビュー、SDV、およびクエリ解決
▪ 施設とのコミュニケーションおよび管理の責任
▪ プロジェクトチームと施設間のコミュニケーション窓口
▪ 施設ごとの目標症例数の協議・記録、および目標達成の確保、およびプロジェクトタイムラインの遵守
▪ フィジビリティリ調査の遂行
▪ 臨床試験関連書類の準備における薬事チームのサポート
▪ 施設監査・当局査察の準備および参加
仕事内容変更範囲
会社の指示する業務
職位
ー
募集背景
Recruiting additional staff due to establishment in JAPAN
日本法人立ち上げに伴い増員での募集
募集人数
4人
応募条件
技能/経験
College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
At least 3 years’ site monitoring experience at a CRA II or equivalent qualification level in Japan
Experience in all types of monitoring visits in Phase II and/or III
Experience in feasibility assessment and study set-up process is preferable
Therapeutic area experience in Oncology /Hematology /Gastroenterology (IBD) /Infectious Diseases /Neurology/Renal is a plus
Full working proficiency in Japanese and Intermediate English
PC skills to be able to work with MS Word, Excel and PowerPoint
Ability to plan, multitask and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
Ability to travel up to 30% to 40%
【必須要件】
▪ 生命科学の学位、または同等の教育、訓練、経験
▪ 日本において少なくとも2 年間の独立した施設モニタリング経験
▪ Phase II またはIII の一連のモニタリング業務の経験
▪ MS Office アプリケーションの使用習熟
▪ 計画、マルチタスク、およびダイナミックなチーム環境での業務遂行能力
▪ コミュニケーション、コラボレーション、および問題解決スキル
▪ 日本語ですべての業務遂行能力を行えるレベルの高い日本語スキルおよび中級程度の英語スキル
【歓迎要件】
▪ 腫瘍学/血液学/消化器病学(IBD)/感染症/神経学/腎臓の治療領域の経験
学歴
大学
職務経験
要 (2年以上)
業界経験
ー
年齢
年齢制限不問
英語力
中級以上
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:600万円 ~ 1,000万円
月収:50万円~83万円
月額基本給:50万円~83万円
賞与・インセンティブ
昇給
有り 年1回
勤務地
大阪府 東京都
東京:千代田区丸の内二丁目6 番1 号丸の内パークビルディング8 階xLINK 丸の内(区画No. 15 )
大阪:大阪市北区梅田2-2-2 ヒルトンプラザウエストオフィスタワー18階
交通手段1 沿線名:各線 駅名:東京 最寄駅から:徒歩1分
交通手段2 沿線名:各線 駅名:大阪 最寄駅から:徒歩3分
勤務地変更範囲
出向
就業時間
09:00~18:00
休憩時間:60分
残業:月5時間~20時間程度
フレックスタイム制
コアタイム 11:00 ~ 14:00
残業手当
通常の残業代
通勤手当
交通費:全額支給
その他手当
休日・休暇
完全週休二日制, 土, 日, 祝日, 年末年始
年間休日:125
年間有給休暇:初年度 最大10日(入社月によって異なる)
社会保険
雇用保険, 健康保険, 労災保険, 厚生年金
福利厚生
各種社会保険完備
受動喫煙対策
就業場所 全面禁煙
備考
在宅勤務有り
選考内容
選考プロセス
適性試験:無し 、 面接回数:2回
求人No.:NJB2273386
最終更新日:2026/1/23
企業情報
企業名
PSI CRO Japan株式会社
代表者名
代表取締役 Nick Sinackevich (シナケヴィッチ・ニック) PSI Japan Country Manager: Sayaka Kaji (梶さやか)
設立
2024年9月
従業員数
30名(2026年2月)
資本金
10,000,000円
本社所在地
〒103-0025 東京都千代田区丸の内二丁目6番1号 丸の内パークビルディング8階xLINK丸の内(区画No.15)
株式公開
日系・外資
外資
事業内容
PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.
In an industry where cost-cutting and layoffs are common, PSI stands out as a stable and secure workplace. Our dedication to stability is evident in our exceptionally high repeat and referral business rate and minimal staff turnover. Many of our colleagues have been with us for over 15 years, contributing to our long-standing traditions and history. Our expansion into Japan continues this legacy, and we seek team members who will grow with us for the long term.
At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.
We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.
事業に関する特色
■Mission
Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors.
Employees come first because being in the people business, we know only happy employees can make happy clients, sites, and vendors. In fact, we do not like the word “employees” and hardly ever use it. We prefer to say “teammates”.
We work in teams, and that shapes our collective mindset. Connection and interdependence are important to us and we devote time, attention, and funds to bring teams together. Many newcomers quickly comment on the uncommon team atmosphere they perceive here from day one.
■Management
PSI is privately owned by a group of managers who set it up a quarter of a century ago and still come to work every day.
These folks succeeded in keeping the company fully independent. In our industry, this is unique and gives us great advantage and freedom.
The power distance within PSI is very short. It is routine for our upper level officers to be involved in all sorts of dialogue with teammates of all levels. We make a point to be approachable, receptive to new ideas, and open to feedback. After all, we want to identify our weaknesses before the market does.
Both our country and functional management have a fair degree of autonomy in making decisions and creating an engaging working environment. They have operational freedom to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.
■The PSI Advantage
PSI CRO has received 2024 CRO Leadership Awards in the categories of Expertise, Quality, Compatibility, and Reliability in the Overall (combined Big and Small Pharma) respondent group. This is the seventh consecutive year that PSI has received leadership awards presented by Clinical Leader and Life Science Connect based on research conducted by ISR. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.
会社の特色
ー
その他の特色
ー
売上実績
求人No.:NJB2273386
最終更新日:2026/1/23

