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Parexel
Parexel Initiation Clinical Research Associate Recruitment 2026: Apply Online
Initiation Clinical Research Associate (iCRA) / 臨床試験立ち上げ担当者
Experience Required
Mid-Level to Senior
Salary / Package
Competitive Corporate Salary
Work Mode
Hybrid / Flexible
Openings
1
Job Overview
- As an Initiation Clinical Research Associate (iCRA) at Parexel, you will spearhead clinical trial site start-up activities ranging from site selection to full activation.
- Your primary responsibility will be executing first-time submissions, preparing essential study documents, and maintaining compliance with global and local regulations.
- Collaborate remotely via phone and email with investigator sites, managing Institutional Review Board (IRB) and Ethics Committee documentation.
- Draft, review, and localize Japan Country Informed Consent Forms (ICFs) and manage vendor access setup for smooth site activation.
- Ensure meticulous translation and quality control of clinical trial documents while maintaining compliance with Standard Operating Procedures (SOPs).
- Work closely with internal cross-functional teams and global stakeholders to ensure timelines, client requirements, and quality standards are fully met.
- Participate in continuous learning and skill enhancement programs supported by Parexel’s robust career development framework.
- Embrace Parexel’s core value of ‘Patients First’, ensuring that every operational step contributes to bringing innovative medical treatments to patients faster.
Key Job Details
| Company Name | Parexel |
| Job Role | Initiation Clinical Research Associate (iCRA) / 臨床試験立ち上げ担当者 |
| Experience | Mid-Level to Senior |
| Salary Range | Competitive Corporate Salary |
| Job Type | Full-Time |
| Work Mode | Hybrid / Flexible |
| Openings | 1 |
| Job Location | Tokyo, Japan |
Key Responsibilities
- Handle remote communication with investigator sites for document collection and regulatory submissions.
- Prepare IRB/Ethics Committee submission materials and local ICF documents.
- Manage site activation milestones, vendor access rights, and clinical drug supply readiness.
- Review regulatory documents, clinical protocols, and ensure adherence to SOPs.
- Seamlessly transition activated sites to monitoring CRAs upon completion of the start-up phase.
Requirements & Qualifications
- Demonstrated experience as a Clinical Research Associate, with site start-up experience preferred.
- Familiarity with initial IRB processes, clinical trial frameworks, and regulatory requirements.
- Proficiency in handling English-language technical manuals, clinical systems, and documentation.
- Strong interpersonal skills, attention to detail, and ability to manage multiple project schedules effectively.
- Experience working with large-scale or university hospital clinical trial settings.
Required Skills
- Clinical Research & Site Activation
- Regulatory Compliance & IRB Submissions
- Bilingual Communication (English & Japanese)
- Document Translation & Review
- Time Management & Organization
- Problem-Solving & Self-Starter Mentality
About Parexel
Parexel is a leading global clinical research organization (CRO) dedicated to accelerating the development of innovative new treatments to help patients live healthier lives. With a strong patient-centric culture and a global team of clinical professionals, Parexel provides comprehensive drug development services from early phase to commercialization.
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Frequently Asked Questions
Q: What is the primary role of an Initiation Clinical Research Associate at Parexel?
A: The iCRA manages clinical trial site start-up activities, including document preparation, IRB submissions, and site activation prior to handing over to the CRA team.
Q: Where is this job located?
A: This position is based in Tokyo, Japan, with flexible work options available.
Q: What language skills are needed for this role?
A: Candidates must be able to work comfortably in an English environment for manuals and systems, alongside strong Japanese communication skills for local site interactions.
Q: What experience is preferred?
A: Prior experience as a Clinical Research Associate with a focus on site start-up, IRB procedures, and global clinical trials is highly preferred.
Q: How can I apply for this position?
A: You can apply online through the official application link provided on the career portal.
Disclaimer: This job post is prepared by collecting data from the official career page of Parexel. We are not direct recruiters or representatives. Candidates should carefully review the requirements and policies on the company’s portal before initiating an application.