Clinical Research Associate/CRA (Japanese/Korean or Japanese/Taiwanese Speaker)
Primary Location: Japan, Tokyo Additional Locations: Japan, Osaka Job ID R0000037819 Category Clinical Trials Date Posted 01/07/2026Overview
As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.
Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Flexible
- Organized
- Problem-solver
- Self-starter
About This Role
※English version follows after the Japanese text.
経験CRA（臨床開発モニター）／血液腫瘍領域
■ポジション概要
パレクセルでは、日本語＋韓国語または台湾華語のスキルをお持ちな、経験CRAを求めています。多言語コミュニケーション力を活かし、グローバル試験の中核メンバーとしてキャリアを広げませんか？
■このポジションの魅力
血液腫瘍領域の最前線：高度な専門スキルを習得し、市場価値を高める
国際的な活躍：日本語＋韓国語／台湾華語を活かしたグローバル試験運営
キャリアパスの多様性：リードCRA、品質監査、プロジェクト管理など
成長支援：チーム連携・学習機会が豊富、監査対応やSME育成も視野に
社会的意義：一つひとつのプロジェクトが患者さんの選択肢を広げる使命
■主な業務内容
治験開始～終了までのサイト管理、プロトコル遵守確認
治験責任医師・サイトスタッフとの関係構築、課題解決
オンサイト／リモート訪問（資格確認・開始・モニタリング）
データ品質・整合性の確認、是正措置の提案・実行
規制文書の収集・確認、監査・査察対応
リクルートメント計画の評価・改善提案
CTMS／EDC等のシステム更新、TMF提出、ISF管理
ICH-GCPおよび各国法規の遵守
■応募資格
必須要件
サイト管理または臨床試験関連業務の経験（CRA経験歓迎）
日本語＋韓国語、または日本語＋台湾華語（マンダリン）：ビジネスレベル以上
問題解決力、コミュニケーション力、時間管理能力（タイムマネジメント）
CTMS・EDMS・MS Office（Excel/Word）の基本操作
歓迎要件（あると尚良し）
血液腫瘍領域での治験経験
国際試験でのドキュメント管理・監査対応経験
出張対応（必要に応じて運転免許）
■学歴
学士号（生物科学、薬学、医療関連分野）または看護資格、同等の経験
■求める人物像
自律的に業務を進め、チーム連携を重視できる方
変化に柔軟に対応し、学び続ける姿勢のある方
患者志向で、品質を最優先にできる方
■勤務地・働き方
東京本社 or 大阪オフィス／在宅ワークのハイブリッドスタイル
※月1~2回ほど、韓国または台湾への出張あり
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Experienced CRAs with Hematologic Oncology studies
Language requirements:
1) Japanese and Korean with professional working proficiency or above
2) Japanese and Taiwanese Mandarin with professional working proficiency or above
Key Accountabilities:
Maintenance (from initiation through close out):
Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
Build relationships with investigators and site staff.
Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
Address/evaluate/resolve issues pending from the previous visit, if any.
Follow-up on and respond to appropriate site related questions.
Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
Conduct remote visits/contacts as requested/needed.
Generate visit/contact report.
Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
Assess & manage test article/study supply including supply, accountability and destruction/return status.
Review & follow-up site payment status.
Follow-up on CRF data entry, query status, and SAEs.
Conduct on-site study-specific training (if applicable).
Perform site facilities assessments
Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution
Overall Accountabilities from Site Identification to Close out:
Ensure timely and accurate completion of project goals and update of applicable trial management systems.
Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
Ensure that assigned sites are audit and inspection ready
Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
Show commitment and perform consistent high-quality work.
Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
Provide input and feedback for Performance Development Conversation(s).
Proactively keep manager informed about work progress and any issues.
Develop expertise to become a subject matter expert.
Work in a self-driven capacity, with limited need for oversight.
Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)
Skills:
Sound problem solving skills.
Able to take initiative and work independently, and to proactively seek guidance when necessary.
Advance presentation skills.
Client focused approach to work.
Ability to interact professionally within a client organization.
Flexible attitude with respect to work assignments and new learning.
Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
Willingness to work in a matrix environment and to value the importance of teamwork.
Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
Strong interpersonal, verbal, and written communication skills.
Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.
Effective time management in order to meet study needs, team objectives, and department goals.
Developing ability to work across cultures.
Shows commitment to and performs consistently high-quality work.
Ability to successfully work in a (‘virtual’) team environment.
Consulting Skills
Great attention to detail.
Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.
Holds a driver’s license where required.
Knowledge and Experience:
Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Education:
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Potential Career Path
Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.
- APEX CRA
- CRA I
- CRA II
- Senior CRA
- Project ManagementSubject Matter ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
Why Clinical Research Associates work at Parexel
