14 set - Monza
Iqvia
Overview
In this role you support multicenter clinical studies by monitoring sites to ensure protocol adherence and data reporting per GCP/ICH guidelines. You will drive site communication, training, and recruitment alignment to project needs, and manage study progress and documentation in collaboration with the study team. The role includes ensuring TMF/ISF integrity, filtering quality issues, and possibly supporting start-up activities and site financials. You join a global, integrity-driven organization focused on advancing patient outcomes.
Responsabilità
- Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and regulatory requirements (GCP/ICH)
- Drive and track subject recruitment plans to improve predictability
- Administer protocol training to sites and maintain regular communication on project expectations
- Assess quality and integrity of site practices and escalate issues
- Track regulatory submissions, approvals, recruitment, CRF completion, data query handling; may support start-up
- Maintain Trial Master File and Investigator's Site File per GCP/ICH and local regs
- Document site management activities, visit findings, and action plans; prepare visit reports and follow-up letters
- Collaborate with study team for project execution; may support site recruitment plan development and invoice retrieval as applicable
Requisiti fondamentali
- CRA certification according to Ministerial requirements
- CRA training or prior monitoring experience
- Basic knowledge of GCP/ICH regulations
- Good therapeutic and protocol knowledge (training provided)
- MS Office skills (Word, Excel, PowerPoint); laptop and mobile devices usage
- Strong written and spoken English
- Organizational and problem-solving skills
- Time and financial management skills
- Ability to build effective working relationships
- effective communication
- problem-solving
- time management
- GCP/ICH regulatory knowledge
- site monitoring and data integrity
- regulatory submissions tracking
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