Senior Clinical Research Associate
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Overview
Senior Clinical Research Associate (home-based in Italy) joins Strategic Resourcing Solutions within TFS Health Science to monitor clinical trials and ensure GCP/ICH compliance. You will work on-site and remotely as part of a project team, focusing on data integrity, participant safety, and regulatory adherence. This role offers impact across study sites and an opportunity to contribute to a global CRO known for collaboration and patient-centric solutions. You will shape monitoring strategies in oncology and other therapeutic areas with a supportive, cross-functional team.
Retribuzione / Benefits
- Permanent contract
- Salary 53.000-55.000 gross/year (Level III)
- Lunch vouchers
- Health insurance
- Pension
- Car allowance where applicable
Responsabilità
- Monitor on-site and remote clinical trials per SOPs, GCP and ICH guidelines; ensure subject safety and data quality
- Verify informed consent and protocol compliance; protect participant rights
- Review CRFs and source data for accuracy and validity
- Verify Investigational Product accountability and handling
- Timely reporting of monitoring findings and CAPAs; update tracking systems and escalate issues
- Provide sites with issue lists and action items for timely resolution
- Ensure timely delivery of site documents to eTMF/paper TMF; maintain ISF per regulatory requirements
- Participate in audit/inspection preparation and follow-up
- Order, ship and reconcile clinical supplies for sites, if applicable
- Update CTMS and other project systems with accurate site-level information
Requisiti fondamentali
- Bachelor's degree in life sciences or nursing, or equivalent
- At least 5 years of clinical trial monitoring experience
- 3 years of oncology experience, preferably in early-phase trials
- Strong knowledge of GCP/ICH guidelines and regulatory requirements
- Fluent in English; strong written and verbal communication
- Ability to work independently and in a matrix team; fast-paced environment
- Good medical terminology and science understanding related to assigned drugs and therapeutic areas
- Willingness to travel 60-80%, including overnight and abroad
- Self-awareness
- flexibility
- proactivity
- GCP/ICH regulatory knowledge
- CTMS
- eTMF
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