Responsibilities (a) Site management •brTodas las habilidades, cualificaciones y experiencia relevantes que necesitará un candidato seleccionado se enumeran en la siguiente descripción.brStudy site selection, initiation (SIV) and clinical monitoring. •brPerform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience. •brPrepare 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. •brEnsure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP. •brTrack study recruitment to ensure recruitment target is achieved in all studies. •brConduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating. •brEnsure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study. •brAssemble site specific EC submission dossier, and ensure submission to EC. Training •brProvide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.



•brConduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation •brEnsure 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. •brPrepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety •brEnsure safety information is disseminated to all sites according SOP and applicable regulations. •brEnsure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration •brFinalize budget and obtain signed contract from site, prior to site initiation visit. •brEnsure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system •brUpdate and maintain Study tools/systems in a timely manner.br3. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. xsgfvud 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.brHay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.

📌 Contractor cra_spain (Vigo)
🏢 Tigermed
📍 Vigo