Responsibilities Las cualificaciones, habilidades y toda la experiencia relevante necesaria para este puesto se pueden encontrar en la descripción completa a continuación. (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. 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. (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. 3.
Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. xgwbsxa 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. Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.