Tigermed
Contractor CRA_UK
United Kingdom
Posted about 12 hours ago
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Responsibilities
(a) Site management
- Study site selection, initiation (SIV) and clinical monitoring.
- Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.
- Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.
- Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.
- Track study recruitment to ensure recruitment target is achieved in all studies.
- Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.
- Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.
- Assemble site specific EC submission dossier, and ensure submission to EC.
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Training
- Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.
- Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.
Documentation
- Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.
- Prepare/complete study records’ archiving according to protocol and sponsor requirements.
(b) Drug Safety
- Ensure safety information is disseminated to all sites according SOP and applicable regulations.
- Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.
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(c) Finance and Administration
- Finalize budget and obtain signed contract from site, prior to site initiation visit.
- Ensure Study Payment Schedule is executed and retain relevant documents/receipts.
(d) Study Tools and system
- Update and maintain Study tools/systems in a timely manner.
Qualifications
3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major.
3.2 At least 8 years of CRA experience.
3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures.
3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.
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Skills
Site Management
Clinical Monitoring
ICH-GCP
Study Site Selection
Safety Reporting
SDV Plan
EC Submission
Drug Safety
Budget Finalization
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Outlook
Location