Clinical Research Associate

12 ago - Roma
Altro

Veeda Lifesciences is seeking a Clinical Research Associate (CRA) based in Italy for its growing international hematology/oncology Clinical Trials program.

Prima di candidarsi per questo ruolo, la preghiamo di leggere le seguenti informazioni su questa occasione, riportate di seguito.

The position is offered on a freelance basis.

This is a full-time job.

Job overview:
The CRA is responsible for ensuring that the conduct of a clinical trial at selected Investigational Sites is according to the currently approved protocol/amendments, ICH GCP guidelines, the applicable Standard Operating Procedures (SOPs) and the applicable laws and regulations.

He/she is the primary responsible person for communication on operational study related activities between the Sponsor, the Investigator and other study personnel to build and maintain successful working relationships.

The most important responsibility is to ensure that the subjects’ rights are respected and that all collected clinical trial data are accurate, complete, and verifiable from source documents.

Main responsibilities:





Ensure compliance with ICH-GCP guidelines, company SOPs, quality standards, and applicable local/international regulations, including data protection legislation.

Conduct feasibility, site selection, initiation, monitoring, and close-out visits at investigational sites.

Collaborate with Regulatory Affairs and Clinical Operations teams on study submissions, contracts, and regulatory documentation.

Train investigators and site staff on study protocols, procedures, safety reporting, and GCP requirements.

Monitor clinical trial activities to ensure protocol compliance, patient safety, data integrity, and adequate site performance.

Review eCRF data against source documentation and ensure informed consent procedures are properly conducted and documented.

Oversee investigational product management, including shipment, storage, dispensing, accountability, and destruction.

Monitor patient recru

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