Clinical Research Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79qagk

ppVeeda Lifesciences is seeking a Clinical Research Associate (CRA) based in Italy for its growing international hematology/oncology Clinical Trials program. /p pbThe position is offered on a freelance basis. /b /p pbThis is a full-time job. /b /p h3Job overview: /h3 pThe 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. /p pHe/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. /p pThe 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. /p h3Main responsibilities: /h3 ul liEnsure compliance with ICH-GCP guidelines, company SOPs, quality standards, and applicable local/international regulations, including data protection legislation. /li liConduct feasibility, site selection, initiation, monitoring, and close-out visits at investigational sites. /li liCollaborate with Regulatory Affairs and Clinical Operations teams on study submissions, contracts, and regulatory documentation. /li liTrain investigators and site staff on study protocols, procedures, safety reporting, and GCP requirements. /li liMonitor clinical trial activities to ensure protocol compliance, patient safety, data integrity, and adequate site performance. /li liReview eCRF data against source documentation and ensure informed consent procedures are properly conducted and documented. /li liOversee investigational product management,



including shipment, storage, dispensing, accountability, and destruction. /li liMonitor patient recruitment, enrollment targets, and study timelines in collaboration with investigators. /li liPrepare monitoring visit reports, follow-up communications, and maintain accurate study documentation and Trial Master Files. /li liSupport safety reporting activities and ensure timely submissions to IECs/IRBs and Regulatory Authorities. /li liAssist sites during audits and inspections and support implementation of corrective actions where required. /li liParticipate in study meetings, departmental initiatives, SOP development, and continuous improvement activities. /li /ul h3Job Requirements: /h3 ul liBachelor’s and/or master’s degree (preferably in Health Sciences) /li liCertified CRA (mandatory), with an Italian degree/certification /li liAt least 1 year experience as a freelance CRA /li liExcellent command of English and Italian both oral and written /li liAttendance of an ICH GCP training course (desirable) /li liGood organizational skills /li liAbility to work independently and be a good team player at the same time /li liAbility to communicate diplomatically, but also effectively with study Site personnel /li liAbility to deal adequately with stressful situations, flexible timelines and work pressure /li liAbility to maintain complete overview and deal with several issues at the same time /li liAbility to work according to specific SOPs, guidelines, regulations ethical principles in the daily practice /li liAbility for frequent international and local travelling, including evenings and overnight stays /li /ul pJoin 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. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79qagk