Contractor Cra_italy

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ku6ay

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 ex

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ku6ay