pResponsibilities /pp(a) Site management /pp• Study site selection, initiation (SIV) and clinical monitoring.
Las cualificaciones, habilidades y toda la experiencia relevante necesaria para este puesto se pueden encontrar en la descripción completa a continuación.
/pp• 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.
/pp• 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.
/pp• Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.
/pp• Track study recruitment to ensure recruitment target is achieved in all studies.
/pp• Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.
/pp• Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.
/pp• Assemble site specific EC submission dossier, and ensure submission to EC.
/ppTraining /pp• Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.




/pp• Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.
/ppDocumentation /pp• 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.
/pp• Prepare/complete study records’ archiving according to protocol and sponsor requirements.
/pp(b) Drug Safety /pp• Ensure safety information is disseminated to all sites according SOP and applicable regulations.
/pp• Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.
/pp(c) Finance and Administration /pp• Finalize budget and obtain signed contract from site, prior to site initiation visit.
/pp• Ensure Study Payment Schedule is executed and retain relevant documents/receipts.
/pp(d) Study Tools and system /pp• Update and maintain Study tools/systems in a timely manner. xqbhyrx
/p p3.
Qualifications /pp3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major.
/pp3.2 At least 8 year of CRA experience; /pp3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; /pp3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.
/p

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