Clinical Research Associate Ii
2 weeks ago
**Job Description & Requirements**:
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 an 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 required
10 Proactively identify and facilitate resolution of complex study problems and issues.
11. Actively work towards achieving good personal relationships with the project Team members
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