Clinical Research Associate

09 ott - Lazio
Trial Form Support

OverviewIn this role you will monitor clinical trials on-site and remotely, ensuring patient safety and data integrity.
You will work within the Strategic Resourcing Solutions team to support study conduct, regulatory compliance, and effective site management.
You will collaborate with cross-functional teams to maintain high-quality trial documentation and support audits/inspections.
This position offers impact in oncology trials within a global, patient-focused CRO.
You will contribute to delivering compliant, timely trial execution in a fast-paced environment.
Retribuzione / Benefitspermanent contract
salary ************* gross/year
lunch vouchers
health insurance
pension
car allowance where applicable
ResponsabilitàMonitor on-site and remote clinical trials per SOPs, GCP and ICH guidelines
Assess and ensure subject safety, data integrity, and quality through monitoring activities
Verify informed consent and protocol compliance
Review CRFs and source documentation for accuracy
Manage Investigational Product accountability
Report findings and CAPAs in Monitoring Visit Reports and update tracking systems




Provide site with issue listings and action items with timely resolution
Ensure timely delivery of site documents to eTMF/TMF and maintain ISF per regulations
Participate in audits/inspections and related activities
Order, ship, and reconcile clinical supplies as applicable
Update CTMS and other project systems with accurate site information
Requisiti fondamentaliBachelor's degree, life science or nursing preferred; or equivalent
At least 3 years of experience monitoring clinical trials in Oncology
Ability to work in a fast-paced environment with changing priorities
Understanding of medical terminology and therapeutics
Knowledge of GCP and ICH guidelines
Ability to work independently and in a matrix team
Strong written and verbal communication
Fluent in English
Excellent organizational skills
Technology savvy with good software skills
Willingness to travel up to *****% (overnight and abroad)
Self-awareness
Resolute
Flexibility
GCP and ICH guidelines
CTMS usage
eTMF/TMF handling

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