Contractor CRA_Italy

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