h3Overview /h3 pIn this home-based role, you will monitor clinical trials in oncology across sites, ensuring patient safety, data integrity, and regulatory compliance. You'll work within the Strategic Resourcing Solutions team to support study conduct, site management, and quality by adhering to GCP/ICH and SOPs. You'll coordinate monitoring activities, manage documentation, and participate in audits, enabling successful study execution. This position offers global collaboration, travel, and opportunities to contribute to meaningful patient outcomes. /p h3Retribuzione / Benefits /h3 ul licompetitive compensation package /li lilunch vouchers /li lihealth insurance /li lipension /li licar allowance where applicable /li /ul h3Responsabilità /h3 ul liMonitor on-site and remote trials per SOPs, GCP/ICH and regulations /li liEnsure patient safety, data integrity,



and quality through monitoring activities /li liVerify informed consent and protocol adherence /li liReview CRFs and source data for accuracy /li liManage Investigational Product accountability /li liReport monitoring findings and CAPA actions; update tracking systems /li liProvide sites with issue lists and timely action items /li liEnsure timely delivery of documents to eTMF/paper TMF; maintain ISF per regulations /li liParticipate in audits/inspections preparation and follow-up /li liOrder, ship, and reconcile clinical supplies if applicable /li liUpdate CTMS and project systems with site information /li /ul h3Requisiti fondamentali /h3 ul liBachelor's Degree in Life Science or Nursing or equivalent /li liAt least 3 years of experience monitoring clinical trials in Oncology (including at least one early-phase study) /li liAbility to work in fast-paced environments with changing priorities /li liStrong understanding of medical terminology and pharmacology of assigned drugs /li liKnowledge of GCP, ICH guidelines, and regulatory requirements /li liAbility to work independently and in a matrix team /li liStrong written and verbal communication skills /li liFluent in English /li liExcellent organizational skills /li liTech-savvy with good computer skills /li liWillingness to travel 60-80% domestically and abroad /li /ul ul liSelf-awareness /li liflexibility /li liproactivity /li liGCP/ICH knowledge /li liCTMS proficiency /li lieTMF knowledge /li /ul #J-18808-Ljbffr

📌 (Senior) Clinical Research Associate (Italia)
🏢 Trial Form Support
📍 Italia