OverviewIn 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.Retribuzione / Benefitscompetitive compensation packagelunch vouchershealth insurancepensioncar allowance where applicableResponsabilitàMonitor on-site and remote trials per SOPs, GCP/ICH and regulationsEnsure patient safety, data integrity,
and quality through monitoring activitiesVerify informed consent and protocol adherenceReview CRFs and source data for accuracyManage Investigational Product accountabilityReport monitoring findings and CAPA actions; update tracking systemsProvide sites with issue lists and timely action itemsEnsure timely delivery of documents to eTMF/paper TMF; maintain ISF per regulationsParticipate in audits/inspections preparation and follow-upOrder, ship, and reconcile clinical supplies if applicableUpdate CTMS and project systems with site informationRequisiti fondamentaliBachelor's Degree in Life Science or Nursing or equivalentAt least 3 years of experience monitoring clinical trials in Oncology (including at least one early-phase study)Ability to work in fast-paced environments with changing prioritiesStrong understanding of medical terminology and pharmacology of assigned drugsKnowledge of GCP, ICH guidelines, and regulatory requirementsAbility to work independently and in a matrix teamStrong written and verbal communication skillsFluent in EnglishExcellent organizational skillsTech-savvy with good computer skillsWillingness to travel 60-80% domestically and abroadSelf-awarenessflexibilityproactivityGCP/ICH knowledgeCTMS proficiencyeTMF knowledge
📌 (Senior) Clinical Research Associate (Casagiove)
🏢 Trial Form Support
📍 Casagiove
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