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TFS HealthScience - Contract Research Organization is a global contract research organization supporting biotechnology and pharmaceutical companies throughout clinical development. Its services span Phase I–III trials, Phase IV real-world evidence studies, and strategic resourcing, with expertise across dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. The company combines the capabilities and international reach of a full-service CRO with the flexibility and personalized collaboration of a mid-sized organization.
Senior Clinical Research Associate, Oncology (Contract, Italy Remote)
Home-based Senior Clinical Research Associate role supporting oncology trials for TFS HealthScience. Responsibilities include site monitoring, compliance oversight, documentation, reporting, and trial-system updates.
Description
- Serve as an operational member of the project team
- Open, monitor both on-site and remotely, and close clinical trial sites
- Conduct trial monitoring in line with company and sponsor SOPs, GCP, ICH guidelines, and applicable regulations
- Carry out monitoring activities that protect subject safety and support data integrity and study quality
- Confirm proper informed consent processes and adherence to study protocols
- Assess electronic and paper CRFs and source records for accuracy and validity
- Check investigational product management and accountability
- Prepare Monitoring Visit Reports, record findings and corrective or preventive actions, maintain tracking systems, and escalate concerns
- Communicate identified issues and required follow-up actions to study sites
- Submit site documentation to the eTMF or paper TMF and confirm Investigator Site File upkeep
- Support preparation for audits and inspections and complete related follow-up
- Order, ship, and reconcile clinical investigation supplies when required
- Maintain accurate site information in CTMS and other project systems
Requirements
- Bachelor’s degree in life sciences or nursing preferred, or an equivalent qualification
- At least three years of clinical trial monitoring experience in oncology, including at least one Phase I or Phase II study
- Working knowledge of medical terminology and the science relevant to assigned drugs and therapeutic areas
- Knowledge of Good Clinical Practice regulations and ICH guidelines
- Capacity to work independently within a matrixed team environment
- Strong written and spoken communication skills
- Fluency in English
- Highly organized approach to work
- Confidence with technology, software, and computer applications
- Willingness and ability to travel up to 60–80%, including overnight and international travel where applicable
Benefits
- Competitive compensation package
- Comprehensive benefits offering
- Opportunities for personal and professional development
- Lunch vouchers
- Health insurance
- Pension plan
- Car allowance where applicable
- Collaborative, innovative working environment
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