(Senior) Clinical Research Associate
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Sebbene l'esperienza professionale e le qualifiche siano fondamentali per questo ruolo, si assicuri di verificare di possedere le soft skill preferenziali, se richieste, prima di candidarsi.
In 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 / Benefits
competitive compensation package
lunch vouchers
health insurance
pension
car allowance where applicable
Responsabilità
Monitor on-site and remote trials per SOPs, GCP/ICH and regulations
Ensure patient safety, data integrity, and quality through monitoring activities
Verify informed consent and protocol adherence
Review CRFs and source data for accuracy
Manage Investigational Product accountability
Report monitoring findings and CAPA actions; update tracking systems
Provide sites with issue lists and timely action items
Ensure timely delivery of documents to eTMF/paper TMF; maintain ISF per regulations
Participate in audits/inspections preparation and follow-up
Order, ship, and reconcile clinical supplies if applicable
Update CTMS and project systems with site information
Requisiti fondamentali
Bachelor's Degree in Life Science or Nursing or equivalent
At 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 priorities xlwpduy
Strong understanding of medical terminology and pharmacology of assigned drugs
Knowledge of GCP, ICH guidelines, and regulatory requirements
Ability to work independently and in a matrix team
Strong written and verbal communication skills
Fluent in English
Excellent organizational skills
Tech-savvy with good computer skills
Willingness to travel 60-80% domestically and abroad
Self-awareness
flexibility
proactivity
GCP/ICH knowledge
CTMS proficiency
eTMF knowledge
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