Clinical Research Associate

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.

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 recruitment, enrollment targets, and study timelines in collaboration with investigators.
• Prepare monitoring visit reports, follow-up communications, and maintain accurate study documentation and Trial Master Files.
• Support safety reporting activities and ensure timely submissions to IECs/IRBs and Regulatory Authorities.
• Assist sites during audits and inspections and support implementation of corrective actions where required.
• Participate in study meetings, departmental initiatives, SOP development, and continuous improvement activities.

Job Requirements:

• Bachelor’s and/or master’s degree (preferably in Health Sciences)
• Certified CRA (mandatory), with an Italian degree/certification
• At least 1 year experience as a freelance CRA
• Excellent command of English and Italian both oral and written
• Attendance of an ICH GCP training course (desirable)
• Good computer skills
• Good general communication skills
• Good organizational skills
• Ability to work independently and be a good team player at the same time
• Ability to communicate diplomatically, but also effectively with study Site personnel
• Ability to deal adequately with stressful situations, flexible timelines and work pressure
• Ability to maintain complete overview and deal with several issues at the same time
• Ability to work according to specific SOPs, guidelines, regulations & ethical principles in the daily practice
• 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.