(Senior) Clinical Research Associate
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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
- 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
- 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
- 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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