Clinical Research (CRA) I or II ※Singapore

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
And for CRA II:
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

And for CRA II,
11. Support/assist in regulatory research/consultancy tasks in relation to clinical trial planning, conduction and product application/registration

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

WORK EXPERIENCE, SKILLS AND KNOWLEDGE:
1.  CRA I: Minimum 1 year 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      
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
2.  CRA I:  Preferably has experience in clinical study monitoring or coordination
CRA II:  Preferably has experience in clinical study monitoring
3. Good knowledge of medical terminology and clinical/medical practices
4. Basic 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.  CRA I:  Possess basic monitoring skills
CRA II:  Possess advanced monitoring skills

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