Responsibilities (a) Site management • Study site selection, initiation (SIV) and clinical monitoring.

Maximice sus posibilidades de que su candidatura sea seleccionada asegurándose de que su CV y sus habilidades se ajustan al perfil.

• 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 • Finaliz

📌 Contractor CRA_Spain (Granadilla)
🏢 Tigermed
📍 Granadilla