Social network you want to login/join with: Senior Clinical Research Associate, Prato
Client: Teleflex Location: Prato, Italy Job Category: Other EU work permit required: Yes Job Reference: 8556790222002585600337140 Job Views: 2 Posted: 27.08.2025 Expiry Date: 11.10.2025 Job Description:
POSITION SUMMARY : The Senior Clinical Research Associate (Senior CRA) is responsible for scheduling and conducting on-site and remote monitoring visits in compliance with applicable regulatory standards (MDR, ISO 14155, ICH/GCP guidelines, Teleflex procedures, and IRB/EC policies). The Senior CRA conducts monitoring visits as identified by the monitoring plan, study team, or department needs to evaluate data accuracy and subject safety. The Senior CRA must identify issues, present findings, provide retraining, and communicate with the study team. A minimum of 5 years of work experience as a clinical trial monitor is required. The Senior CRA also assists with training and developing monitoring tools and procedures. CULTURE: Customer Experience – Representing Teleflex in a customer-facing role is a significant responsibility. All colleagues are expected to perform professionally, ethically, and with high service standards to strengthen the Teleflex brand. Continuous Improvement – Demonstrates initiative to identify and address process and performance gaps, developing solutions for improvement. Culture and Values – Embodies Teleflex values, ensuring a fair, ethical, and compliant work environment, and collaborates effectively across functions. PRINCIPAL RESPONSIBILITIES
Conduct monitoring within timelines and according to plans and procedures. Coordinate with research staff to schedule and perform monitoring visits. Evaluate site practices, escalate issues, and assist in resolving quality concerns. Prepare for visits, ensuring thoroughness and efficiency. Perform monitoring activities per SOPs, guidelines, and regulations. Complete documentation accurately and timely. Present findings, provide training, and resolve data queries. Ensure compliance with safety reporting requirements and local regulations. Support in audits, training, and study-related projects. Mentor new staff and support process improvements. EDUCATION / EXPERIENCE REQUIREMENTS : Bachelor’s or higher in life sciences, nursing, or related fields, or equivalent qualification. At least 5 years’ experience as a CRA in medical device or pharma industry. Knowledge of vascular interventional cardiology or peripheral vascular intervention is advantageous. SPECIALIZED SKILLS & OTHER REQUIREMENTS : Strong knowledge of MDR, ISO 14155, ICH/GCP guidelines. Ability to train and mentor staff, maintain composure, and manage priorities. Excellent communication, organizational, and documentation skills. Proficient with MS Office and remote work tools.
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