CRA or Senior CRA

Publication date 2026/03/3

Work Location , Expected Annual Income :

Tokyo,Osaka,5.0M ～ 8.0M

About the Company :

Start-up Clinical Research Organization

Responsibilities :

Primary Function:
The position will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. Performs all tasks routinely and independently. May act as assessor of peers for assessment visit purposes (as approved).

Key Responsibilities:
・Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance.

・Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.

・Conduct activities following Clinical Monitoring Plan

・Perform investigational product (IP) inventory, reconciliation and reviews storage and security.

・Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.

・Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.

・For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.

・Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.

・Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.

・Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

・May provide training or mentorship to more junior level CRAs.

・May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Trial Manager (CTM), or operational line manager.

Benefits :

Employment Type: Full time employee
Office Location: Tokyo and Osaka
Working Style: FULL REMOTE
Budget Range: Up to 8mil annual total.
Welfare and Insurance: Covered
Interview Steps: 3-4
Language Requirement: Japanese: Native // English: Intermediate

Required Experience / Abilities / Skills :

REQUIREMENTS
・Minimum of 3 years prior clinical monitoring experience.

・Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.

・Demonstrate good computer skills and be able to embrace new technologies.

・Excellent communication, presentation and interpersonal skills.

Contact Information :

JAC International, Healthcare Team
Shino Hiratsuka
Email: s-hiratsuka@jac-international.jp

If you are interested, please email us for an inquiry!

JOB ID : IJB2011392