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.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 -

📌 Contractor Cra_spain (Madrid)
🏢 Tigermed
📍 Madrid