Responsibilities(a) Site management ~¿Está pensando en solicitar este empleo? No se demore, desplácese hacia abajo y envíe su solicitud lo antes posible para no perder la ocasión. 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. xsgfvud 3. Qualifications3.1 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.

📌 Contractor CRA_Spain (Vitoria-Gasteiz)
🏢 Tigermed
📍 Vitoria-Gasteiz