Senior Clinical Research Associate

2 giorni fa

Pistoia, Italia Jr Italy A tempo pieno

Social network you want to login/join with:Senior Clinical Research Associate, PistoiaClient:TeleflexLocation:Job Category:OtherEU work permit required:YesJob Reference:8556790222002585600337160Job Views:2Posted:**********Expiry Date:**********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 *****, ICH/GCP guidelines, Teleflex procedures, and IRB/EC policies).The Senior CRA conducts monitoring visits as identified by the monitoring plan or study needs to evaluate data accuracy and subject safety.The role requires reviewing regulatory documents, medical records, reported data, and device storage.The Senior CRA must identify issues, present findings, provide retraining if needed, and communicate with the study team and management.A minimum of 5 years of experience as a clinical trial monitor is required.The Senior CRA also assists in training and developing monitoring tools and procedures.CULTURE:Customer Experience – Representing Teleflex in a customer-facing role is a significant responsibility and opportunity.All colleagues are expected to perform professionally, ethically, and with high service standards to strengthen the Teleflex brand.Continuous Improvement – Demonstrates initiative and critical thinking 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.Works effectively across boundaries in a complex matrix environment.PRINCIPAL RESPONSIBILITIES:Conduct monitoring within timelines and according to plans and procedures.Schedule and conduct monitoring visits with research staff.Evaluate site practices, escalate issues, and provide feedback.Prepare for visits, maximize efficiency, and follow protocols and guidelines.Complete documentation accurately, including monitoring reports and follow-up letters.Ensure compliance with safety reporting requirements and prepare necessary documentation.Support study-related tasks, including training, audits, and regulatory inspections.Train and mentor new staff and oversee monitoring activities.Assist in adapting guidelines and procedures as needed.Participate in study team activities and ensure proper data management.EDUCATION / EXPERIENCE REQUIREMENTS:Bachelor's or higher degree in life sciences, nursing, or related fields, or equivalent qualification.Knowledge of the medical device sector.At least 5 years' experience in clinical trial monitoring within the medical device or pharmaceutical industry or CRO.Strong attention to detail, organizational skills, and clinical monitoring expertise.Experience in Vascular Interventional Cardiology or Peripheral Vascular Intervention is advantageous.SPECIALIZED SKILLS & OTHER REQUIREMENTS:Strong knowledge of MDR, ISO *****, ICH/GCP guidelines and compliance focus.Ability to train and mentor staff and site personnel.Excellent communication, organizational, and time management skills.Proficiency with MS Office and data management tools.Ability to work independently and remotely, with a suitable home office setup.#J-*****-Ljbffr

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