Experteer Overview
As a CRA II in Italy, you will be the primary contact for trial sites, driving initiation, recruitment, and quality assurance while ensuring compliance with GCP and regulations. You’ll manage site performance, build strong investigator relationships, and troubleshoot issues to keep trials on track. This role supports cross‑country studies and requires travel; you’ll partner with teams to deliver high‑quality data and patient safety. You’ll shape site strategies within a mission‑driven, patient‑focused organization.
Retribuzione / Benefits
- Act as Parexel's direct site contact and safeguard study integrity
- Build and maintain relationships with investigators and site staff
- Facilitate site access to study systems and ensure training compliance
- Assess and adjust site staff assignments and provide corrective actions
- Address site issues, including training gaps and documentation deficiencies
- Participate in meetings, audits, and inspections as required
- Evaluate and support site recruitment plans and strategies
- Conduct on-site and remote visits, document findings, and follow up
- Monitor data quality, query resolution, and SAE follow-up
- Ensure trial management systems (CTMS, EDC, IVRS, SIS) are updated timely
- Manage supply/return of study articles and site payments
- Provide site training and facilities assessments as applicable
- Communicate study issues and propose resolutions to timelines and patient safety
- Maintain audit/inspection readiness and regulatory compliance
- Develop SME expertise and work in a self‑driven, team‑oriented environment
- Oversee TMF documentation and first‑time quality across sites
- Support performance development conversations and manager updates
Responsabilità
- Close to 2 years of independent monitoring experience in a similar setting
- Site management experience or equivalent clinical research background
- Educated to degree level in a health‑related discipline (preferred)
- Ability to travel extensively within Italy
- Knowledge of ICH‑GCP and applicable regulations
- Proficiency with CTMS, EDC, IVRS, and EDMS systems
- Strong problem‑solving, communication, and interpersonal skills
Requisiti fondamentali
