Location: Rome or Bologna, ItalyEmployment Type: Full-timeTravel: Approximately 5–8 site visits per monthPosition SummaryWe are seeking an experienced and motivated Clinical Research Associate (CRA) with a strong background in oncology clinical trials to join our dynamic team. The CRA will be responsible for the full lifecycle of clinical site management, including site setup, monitoring, and close-out activities. This role involves working on complex studies and challenging sites, ensuring compliance with protocols, SOPs, ICH-GCP, and applicable regulatory requirements.Key ResponsibilitiesParticipate in site identification and feasibility assessmentsManage all aspects of study site operations, including training site staff, ensuring supply of study materials and IMP, and providing recruitment updatesCollect, assess, and reconcile essential documents and maintain the Investigator Site FileConduct pre-study, initiation, monitoring, and close-out visits in accordance with SOPs and monitoring plansAssess IP accountability, dispensation, and compliancePrepare and submit accurate and timely monitoring visit reportsCollaborate with Clinical Trial Managers (CTMs), Project Managers, and SponsorsAttend internal and external project meetings to provide site updatesUtilize clinical systems such as CTMS, eTMF, IVRS/IWRS, and EDCSupport and facilitate site audits and resolve audit findingsMentor junior CRAs and lead observational visitsIdentify and escalate quality or data integrity issuesContribute to process improvement initiatives, including SOP and work instruction updatesQualificationsEssentialBachelor’s degree in Nursing, Life Sciences, or Medical Sciences (or equivalent experience)Proven experience as a CRA with a strong understanding of clinical research fundamentalsExperience in oncology trialsProficiency in CTMS, eTMF, IXRS, and EDC systemsExcellent communication and presentation skillsFluent in English and ItalianIn-depth knowledge of ICH-GCP and regional clinical research regulationsAbility to work independently and manage complex sitesStrong problem-solving and decision-making skillsDesirableAdvanced degree (e.g., Master’s, MD, PhD)Prior experience in a CRO environmentExperience in clinical trial planning and metrics managementDemonstrated mentoring and leadership capabilitiesWhy Join Us?Work on cutting-edge oncology trialsBe part of a collaborative and supportive teamOpportunities for career development and mentoringCompetitive compensation and flexible work arrangements