Clinical Research Associate II/Senior Clinical Research Associate※Thai Office

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）として創業して以降、自由な発想と先見性で、製薬業界の中で製造や販売に至るまで様々な新しいサービスを生み出してきました。

現在においては、製薬業界に留まらず、ヘルスケア業界に向けたビジネスの展開も進めており、各プロフェッショナル人材の活躍の場が広がっています。

This is a full time home-based position in Thailand.  

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:

· 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

REQUIREMENTS:

Qualifications

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

Experience and Skills

· 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 
· Good team player with excellent interpersonal and organization skills
· Possess advanced monitoring skills and clinical trial management
· Self-initiative to perform duties
· Meticulous and able to work in a fast-paced environment
· Good team-player
· Ability to multi-task and follow through with assigned tasks
· Demonstrate flexibility and creativity in conflict management and negotiation 

APPLICATIONS: Interested parties please apply via email.

Responsible Person Contact details
Name: Pearlyn Tan
Email: pearlyn-tan@cmicgroup.com