Descrizione dell'offerta
Veeda Lifesciences is seeking a Clinical Research Associate (CRA) based in Italy for its growing international hematology/oncology Clinical Trials program. The position is offered on a freelance basis.
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.
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.
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.
Monitor patient recruitment, enrollment targets, and study timelines in collaboration with investigators.
Support safety reporting activities and ensure timely submissions to IECs/IRBs and Regulatory Authorities.
Bachelor's and/or master's degree (preferably in Health Sciences)
Certified CRA
At least 6-12 months' previous work experience as a CRA
Excellent command of English and Italian both oral and written
Attendance of an ICH GCP training course (desirable)
Good computer skills
Ability to deal adequately with stressful situations, flexible timelines and work pressure
Ability for frequent international and local travelling, including evenings and overnight stays
Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment.
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.
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.
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.
Monitor patient recruitment, enrollment targets, and study timelines in collaboration with investigators.
Support safety reporting activities and ensure timely submissions to IECs/IRBs and Regulatory Authorities.
Bachelor's and/or master's degree (preferably in Health Sciences)
Certified CRA
At least 6-12 months' previous work experience as a CRA
Excellent command of English and Italian both oral and written
Attendance of an ICH GCP training course (desirable)
Good computer skills
Ability to deal adequately with stressful situations, flexible timelines and work pressure
Ability for frequent international and local travelling, including evenings and overnight stays
Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment.