Clinical Research Associate
Descrizione dell'offerta
Location: Rome or Bologna, Italy
Employment Type: Full-time
Travel: Approximately 5–8 site visits per month
Position Summary
We are seeking an experienced and motivated Clinical Research Associate (CRA) with a strong background in oncology clinical trials to join our dynamic team. The CRA will be responsible for the full lifecycle of clinical site management, including site setup, monitoring, and close-out activities. This role involves working on complex studies and challenging sites, ensuring compliance with protocols, SOPs, ICH-GCP, and applicable regulatory requirements.
Key Responsibilities
- Participate in site identification and feasibility assessments
- Manage all aspects of study site operations , including training site staff, ensuring supply of study materials and IMP, and providing recruitment updates
- Collect, assess, and reconcile essential documents and maintain the Investigator Site File
- Conduct pre-study, initiation, monitoring, and close-out visits in accordance with SOPs and monitoring plans
- Assess IP accountability, dispensation, and compliance
- Prepare and submit accurate and timely monitoring visit reports
- Collaborate with Clinical Trial Managers (CTMs), Project Managers, and Sponsors
- Attend internal and external project meetings to provide site updates
- Utilize clinical systems such as CTMS, eTMF, IVRS/IWRS, and EDC
- Support and facilitate site audits and resolve audit findings
- Mentor junior CRAs and lead observational visits
- Identify and escalate quality or data integrity issues
- Contribute to process improvement initiatives , including SOP and work instruction updates
Qualifications
Essential
- Bachelor’s degree in Nursing, Life Sciences, or Medical Sciences (or equivalent experience)
- Proven experience as a CRA with a strong understanding of clinical research fundamentals
- Experience in oncology trials
- Proficiency in CTMS, eTMF, IXRS, and EDC systems
- Excellent communication and presentation skills
- Fluent in English and Italian
- In-depth knowledge of ICH-GCP and regional clinical research regulations
- Ability to work independently and manage complex sites
- Strong problem-solving and decision-making skills
Desirable
- Advanced degree (e.g., Master’s, MD, PhD )
- Prior experience in a CRO environment
- Experience in clinical trial planning and metrics management
- Demonstrated mentoring and leadership capabilities
Why Join Us?
- Work on cutting-edge oncology trials
- Be part of a collaborative and supportive team
- Opportunities for career development and mentoring
- Competitive compensation and flexible work arrangements