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 1 year contract home-based in Kuala Lumpur, Malaysia. The duration of the contract could be extended after CRA performance review.
POSITION PURPOSE:
- To support project(s) as ICH E6 GCP definition of "Monitor"
- To ensure all designated clinical/site monitoring activities are conducted in highest quality standards
Support in operations and/or business's continuality by undertaking tasks such as:
Mentoring and training of new employees as required
Support business development activities
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 an 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 business development activities (e.g. search new project related information) 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 biomedical-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 1 year relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or 1 year direct experience as monitor in clinical studies
- Preferably has experience in clinical study monitoring
- Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations
- Strong interpersonal, problem-solving, organization and time management skills
- Ability to produce meticulous and accurate work under pressure and stringent timelines
- Able to work independently and willingness to travel
- Strong computer/technology skills including MS Word, MS Excel and PowerPoint
- Good written and verbal communication skills
- 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
- Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations
APPLICATION:
Interested parties please apply via email.
Responsible Person Contact details
Name: Pearlyn Tan
Email: pearlyn-
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