要約求人票をもとにAIがまとめたものです

Clinical Research Associate II/Senior Clinical Research Associateとして、ICH E6 GCPに基づく臨床試験のモニタリングを支援し、指定された臨床／施設モニタリング業務が高い品質基準で実施されるようにする。必要に応じてプロジェクトでLead CRAの役割を担い、施設選定、モニタリング訪問、試験関連文書や規制当局・倫理委員会向け資料の作成・提出などを行う。監査・査察、新入社員の研修、事業開発、臨床オペレーション関連のSOPや業務ガイドの整備も支援する。

応募資格

必須

Minimum bachelor degree (major in nursing, pharmacy or other science-related background from a recognized institution, and/or equivalent combination of training and experience
Certificate in basic GCP courses
Certificate in monitoring or equivalent training
Minimum 3 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 4 years direct experience as monitor in clinical studies
Experienced in coordination and preparation for site/CRO audit
Has experience as a clinical lead or any other supervisory/leading role in clinical studies
Good knowledge of medical terminology and clinical/medical practices
Good understanding of cross-functional processes, clinical trial processes and regulatory environment
Good computer/technology skills including MS Word, MS Excel, PowerPoint
Effective written and verbal communication skills, preferably with good command of English in addition to local language
Possess advanced monitoring skills and clinical trial management
Ability to multi-task and follow through with assigned tasks

求める人物像

Good team player with excellent interpersonal and organization skills
Self-initiative to perform duties
Meticulous and able to work in a fast-paced environment
Good team-player

募集要項最終確認 10/2

職種: 臨床開発（CRA・CRC）
雇用形態: Full-Time Employment正社員
役職: Clinical Research Associate II/Senior Clinical Research Associate
給与: 記載なし
給与の詳細: 非公開
勤務地: Thailand *Home-based
働き方: Home-basedThailand *Home-based
学歴: 大学卒業以上
掲載日: 2026/07/03 18:27（91日前）
最終確認: 2026/10/02 12:21（今日）

仕事内容

POSITION PURPOSE

1. To support project(s) as ICH E6 GCP definition of "Monitor"
2. To ensure all designated clinical/site monitoring activities are conducted in highest quality standards
3. To conduct project with Lead CRA role in the project activity as required
Support in operations and/or business's continuality by undertaking tasks such as:
1. Mentoring and training of new employees as required
2. Support business development activities
3. Review, revise and/or develop clinical operations service related work guides or site specific documents etc.

RESPONSIBILITIES AND DUTIES:

·Responsible for performing all monitoring aspects of clinical trials and assist to set up, review and maintain project files to ensure compliance as stated in ICH E6 GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements
·Responsible for preparing, organizing, managing feasibility, site selection and investigator identification, initiation, monitoring and close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements with the highest standards
·Planning, develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents
·Develop, compile and/or submit dossiers include initial/amendment/interim report/safety reporting to regulatory and/or ethics committee for review and follow up until approval, as required
·Management in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required
·Manage/support project(s) in the capacity of lead CRA role and/or other designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the Company
·Support/Assist in Site and CRO audit or inspection as required
·Support Company's operations by assisting/coordinating and conducting orientation , supporting orientation, oversight visit and applicable training for new employees as required
·Support business development activities (e.g. search new project related information, project bidding) as required
·Support review, revise and/or develop Clinical operation related SOPs, work guides etc.
·Support and/or conduct monitoring and Co-monitoring visit and internal documents QC process as required
·Support/assist in regulatory research/consultancy tasks in relation to clinical trial planning, conduction and product application/registration
·Proactively identify and facilitate resolution of complex study problems and issues.
·Actively work towards achieving good personal relationships with the project Team members

この求人はシミックホールディングス株式会社の採用ページの掲載内容をもとに構成しています。応募条件の最新情報は募集元をご確認ください。

Clinical Research Associate II/Senior Clinical Research Associate

要約求人票をもとにAIがまとめたものです

応募資格

必須

求める人物像

募集要項最終確認 10/2

仕事内容

POSITION PURPOSE

RESPONSIBILITIES AND DUTIES:

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