[Janssen] R&D, Clinical Research Associate(CRA)/Site Manager, Global Clinical Operation Japan (Tokyo

[ 概要 ]

治験の実施に関わる施設選定~データベースロック / 治験終了までのモニタリング業務

[ 具体的な業務例 ]

•治験契約締結交渉•初回 IRB 申請手続き

•施設セットアップ,医療関係者トレーニングの実施

•症例登録促進活動の実施, GCP • SOP に基づくモニタリング

•治験の質的管理,原資料等の直接閲覧 / 症例報告書の SDV 実施

•施設における治験費用の管理

•その他,社内の Improvement activity / Task force team への参加

Position Summary:

A Site Manager I in Early Development & Clinical Pharmacology (ED&CP) serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of early development and/or clinical pharmacology studies.

A Site Manager I is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC), applicable regulations and guidelines from start-up through data-base lock.

Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out.

Partners with the Clinical Trial Assistant (CTA), Trial Manager (TM) and Global Trial Leader (GTL) to ensure overall site management while performing trial related activities for assigned protocols.

A Site Manager I may contribute to process improvement and training.

Principal Responsibilities:

1.

Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team

2.

Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.

3.

Attends/participates in investigator meetings as needed.

4.

Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies.

5.

Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial.

Complete retraining when needed.

Ensure training records are filed at sites and sponsor level.

6.

Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.

7.

Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.

8.

In collaboration with Site Investigational Product Specialist (SIPS) and Pharmacy Investigational Product Specialist (PIPS), ensures that clinical drug supplies are appropriately handle...