1. シミックホールディングス株式会社/CMIC HOLDINGS Co., Ltd. (HQ)
  2. シミックホールディングス株式会社/CMIC HOLDINGS Co., Ltd. (HQ) 採用情報
  3. シミックホールディングス株式会社/CMIC HOLDINGS Co., Ltd. (HQ) の求人一覧
  4. Clinical Research Associate (CRA) II or Senior ※Malaysia

Clinical Research Associate (CRA) II or Senior ※Malaysia

  • Clinical Research Associate (CRA) II or Senior ※Malaysia
  • 正社員

シミックホールディングス株式会社/CMIC HOLDINGS Co., Ltd. (HQ) の求人一覧

Clinical Research Associate (CRA) II or Senior ※Malaysia | シミックホールディングス株式会社/CMIC HOLDINGS Co., Ltd. (HQ)

シミックグループは日本初のCRO(Contract Research Organization:医薬品開発受託機関)として、自由な発想と先見性で、医薬の世界に新たなサービスを生み出してきました。現在では医薬品開発だけでなく、製造、販売まで、製薬企業の全てのプロセスを支援するサービスを提供しています。30周年を迎えた現在、個人のヘルスバリューを高めるために新たな挑戦のステージに入っています。従来のビジネスを武器に事業拡大していく中で、グループ横断的に様々なプロジェクトやタスクが複数開始される予定です。

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

Review, revise and/or develop clinical operations service related work guides or site specific documents etc.

RESPONSIBILITIES AND DUTIES:
1. 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
2. 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
3. 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
4. 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
5. Management in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required
6. 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
7. Support/Assist in Site and CRO audit or inspection as required
8. Support business development activities (e.g. search new project related information. As for senior CRA, project bidding also) as required
9. Proactively identify and facilitate resolution of complex study problems and issues.
10. Actively work towards achieving good personal relationships with the project Team members
11. Support/assist in regulatory research/consultancy tasks in relation to clinical trial planning, conduction and product application/registration
And for Senior CRA,
12. Support Company's operations by assisting/coordinating and conducting orientation, supporting orientation, oversight visit and applicable training for new employees as required
13. Support review, revise and/or develop Clinical operation related SOPs, work guides etc.
14. Support and/or conduct monitoring and Co-monitoring visit and internal documents QC process as required

REQUIRED EDUCATION AND QUALIFICATIONS:
1.  For CRA II:  Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience institution, and/or equivalent combination of training and experience
For Senior CRA: Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience
2. Certificate in basic GCP course
3. Certificate in monitoring or equivalent training

WORK EXPERIENCE, SKILLS AND KNOWLEDGE:
1.  For CRA II:  Minimum 3 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or is a qualified pharmacist or medical doctor by training with no previous experience in relevant experience in clinical research
For Senior CRA: Minimum 5 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 4 years direct experience as monitor in clinical studies with good performance
2. For CRA II:  Preferably has experience in clinical study monitoring
For Senior CRA: Experienced in coordination and preparation for site/CRO audit and has experience as a clinical lead or any other supervisory/leading role in clinical studies
3. Good knowledge of medical terminology and clinical/medical practices
4.  For CRA II: Basic understanding of cross-functional processes, clinical trial processes and regulatory environment
For Senior CRA:  Good understanding of cross-functional processes, clinical trial processes and regulatory environment
5. Good computer/technology skills including MS Word, MS Excel, PowerPoint etc.
6. Effective written and verbal communication skills, preferably with good command of English in addition to local language
7. Good team player with excellent interpersonal and organization skills
8.  For CRA II: Possess advanced monitoring skills
For Senior CRA:  Possess advanced monitoring skills and clinical trial management

APPLICATION:
Interested parties please apply to:
pearlyn-tan@cmicgroup.com

職種 / 募集ポジション Clinical Research Associate (CRA) II or Senior ※Malaysia
雇用形態 正社員
給与
非公開
 
勤務地
 
会社情報
会社名 シミックホールディングス株式会社/CMIC HOLDINGS Co., Ltd. (HQ)
創業 / Foundation
1992年(会社設立:1985年3月14日)
In 1992 (The Company was established on March 14, 1985)
代表者 / Representative Directors
代表取締役CEO 中村 和男 / Kazuo Nakamura, Chairman and CEO
代表取締役COO 大石 圭子 / Keiko Oishi, President and COO
従業員数 / No.of Employees
7,878名(連結子会社含む)※2022年5月現在
7,878 (as of April 1, 2022 on a consolidated basis)