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Clinical research associate (ancona)

Ancona
Veeda Lifesciences
Pubblicato il Pubblicato 18h fa
Descrizione

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:-Acknowledges, follows& ensures compliance with the Company's Quality and Information Security Management Systems, ICH GCP guidelines, applicable local and international legislation, including data protection legislation, as well as any amendments or updates the above-In case of deviation from the approved protocol, ICH GCP guidelines and/or applicable legislation during the study conduct, the CRA is responsible for reporting it to the Line Manager and other applicable roles according to SOPs-Conducts pre-study visits at potential investigational sites, to perform the study related feasibility and/or selection activities and evaluate their resources and facilities-Collaborates with the Regulatory Affairs Department and concerned Clinical Operations staff for clinical submissions and contracts respectively for:Managing Hospital IEC study submissions and approvals with follow through to ensure successful outcomePreparation of study contracts & relevant files to be submitted for the study financial management acceptance, as required by the applicable local legisla

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