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About the Role

We are seeking experienced CRAs to join our growing team due to increased project expansion. This role involves conducting monitoring activities according to the Clinical Monitoring Plan (CMP) created by the Clinical Trial Team Leader, based on the clinical trial protocol provided by pharmaceutical and medical device manufacturers. You will be responsible for obtaining the required number of cases and case report forms within the specified period for your assigned project, performing SDV, and creating monitoring reports. Additionally, you will confirm adverse events in subjects and handle serious adverse events.

Responsibilities

Conduct monitoring activities according to the Clinical Monitoring Plan (CMP).
Obtain the required number of cases and case report forms within the specified period for assigned projects.
Perform Source Data Verification (SDV).
Create monitoring reports.
Confirm adverse events in subjects and handle serious adverse events.
Perform site selection, initiation, monitoring, and close-out visits in accordance with contracted scope of work and good clinical practice.

Requirements

Completed GCP training (at CRO, pharmaceutical companies, etc.).
Minimum 2 years of CRA experience in corporate clinical trials (CRA experience under GCP).
Completed the Sign-Off.
Able to visit the site individually.
At least 1 year experience as CRA.
Performed at the University hospital or Oncology hospital.
Acted as a mentor for new clinical staff.

Skills

Knowledge of GCP
Fluent in Japanese

Location

Tokyo
Osaka
Fukuoka
Shinagawa Headquarters
Osaka Business Office

Work Type

Full-time
Employee
Remote work system available

Experience Level

Experienced CRA
2+ years of CRA experience
1+ year of CRA experience
Global project experience

Salary/Compensations

Compensation will be commensurate with experience (company regulations).

Benefits

Individual training for experienced hires (Individual).
Refresher or supplementary courses based on pre-evaluation test results.
Abundant English training available.
Various career paths including Clinical Operations Manager, Clinical Lead, and Project Lead.
Annual paid leave.
Summer vacation.
Sick leave.
Special leave.
Women's special leave.
Childcare/nursing care leave.
Nursing leave.
Statutory benefits (social insurance system).
Non-statutory benefits (IQVIA's unique system).
Overtime allowance.

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Learn more at https://jobs.iqvia.com

Equal Opportunity

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.
All information and credentials submitted in your application must be truthful and complete.
Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.
We appreciate your honesty and professionalism.