Contractor Cra_italy

Responsibilities (a) Site management

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Study site selection, initiation (SIV) and clinical monitoring.

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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.

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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.

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Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.

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Track study recruitment to ensure recruitment target is achieved in all studies.

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Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

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Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

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Assemble site specific EC submission dossier, and ensure submission to EC. Training

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Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

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Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation

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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.

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Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety

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Ensure safety information is disseminated to all sites according SOP and applicable regulations.

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Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration

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Finalize budget and obtain signed contract from site, prior to site initiation visit.

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Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system

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Update and maintain Study tools/systems in a timely manner.

3. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. 3.2 At least 8 year 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.