01 ago
|
Experteer Italy
|
Italia
01 ago
Experteer Italy
Italia
Experteer Overview As a Clinical Research Associate, you monitor and manage study sites to ensure protocol adherence, regulatory compliance, and timely data reporting. You will work with sites to optimize recruitment, train investigators, and maintain essential study documentation. You ensure data quality, handle regulatory submissions, and support start-up activities as needed. This role sits within a broader team focused on delivering high-quality clinical research outcomes and patient-focused results.Retribuzione / Benefits
Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP/ICH guidelines
Collaborate with sites to plan, drive, and track subject recruitment to meet project needs
Administer protocol training and establish ongoing communication to manage expectations and issues
Assess site practices for protocol compliance and regulatory adherence; elevate quality issues
Track regulatory submissions, approvals, recruitment/enrollment, CRF completion/submission, and data queries; may support start-up
Ensure site documents are filed in the Trial Master File (TMF) and ISF maintained per regulatory requirements
Document site management activities, visit findings, and action plans; issue follow-up letters
Collaborate with study team for project execution support; may contribute to recruitment plans and site-level financials when applicable
Responsabilità
Master's Degree in Life Sciences
CRA certification according to ministerial requirements
Completion of CRA training program or prior monitoring experience
Knowledge of GCP/ICH guidelines
Good therapeutic and protocol knowledge as provided in company training
Proficiency in Microsoft Word, Excel and PowerPoint; basic computer proficiency
Strong written and verbal English communication; organizational and problem‑solving skills
Effective time and financial management; ability to build relationships with stakeholders
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📌 CRA - MONITOR (Italia)
🏢 Experteer Italy
📍 Italia