Clinical Research Associate
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In 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 / Benefits- permanent contract
- salary 42.000-52.000 gross/year
- lunch vouchers
- health insurance
- pension
- car allowance where applicable
- Monitor 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
- Bachelor’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 60-80% (overnight and abroad)
- Self-awareness
- Resolute
- Flexibility
- GCP and ICH guidelines
- CTMS usage
- eTMF/TMF handling