Senior Clinical Research Associate

Social network you want to login/join with:Senior Clinical Research Associate, BresciaClient: TeleflexLocation: Brescia, ItalyJob Category: OtherEU work permit required: YesJob Reference: Job 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 14155, ICH/GCP guidelines, Teleflex procedures, and IRB/EC policies and procedures). The Senior CRA conducts monitoring visits as identified by the monitoring plan, study team, or department needs to evaluate data accuracy and subject safety by reviewing regulatory documents, medical records, reported data, and device storage, if applicable. The Senior CRA must be able to identify issues, present findings to the site staff, provide retraining if needed, and communicate findings to the study team and department management via escalation of issues and/or within the monitoring visit report. The Senior CRA has a minimum of 5 years of work experience as a clinical trial monitor. The Senior CRA assists the Management Team with training needs as well as developing and providing input on monitoring tools and procedures.CULTURE:Customer Experience – Representing Teleflex in a customer-facing position is a tremendous responsibility and opportunity.All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics to strengthen the Teleflex brand and relationships with our customers.Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus.Culture and Values – Embodies Teleflex values and ensures a fair, open, and productive environment that is engaging, ethical, and legally compliant. Works effectively across boundaries in a complex matrix environment. Leads and participates in the development of promotional and other materials, working internally and cross-functionally to ensure materials are accurate and based on clinical practice and data.PRINCIPAL RESPONSIBILITIES:Conduct monitoring within timelines and according to the monitoring plan and Teleflex procedures.Coordinate with Research Coordinators and Investigators to schedule and conduct monitoring visits including site qualification, initiation, routine monitoring, and closure.Evaluate site practices, escalate quality issues, and ensure data integrity.Prepare for monitoring visits, including site email communication 1-2 weeks prior, and maximize on-site visit efficiency.Conduct monitoring visits per SOP, WIs, and monitoring plans, applying MDR, ISO 14155, ICH/GCP guidelines, and Teleflex procedures.Complete Investigator Files with all required documentation before, during, and after the study.Present findings, provide directions for resolution, and offer retraining as needed.Serve as a resource to site staff between visits for clarification and insights.Document monitoring activities and action items professionally and accurately.Ensure compliance with safety reporting and data protection requirements, report to Safety Officer, and prepare submission documents as needed.Support study team activities, including training, audits, and regulatory inspections.Oversee training of new personnel and ensure adherence to WIs and guidelines.Assist with eCRF completion, data queries, and study documentation.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 of on-site monitoring experience in clinical trials within medical devices, pharma, or CRO.Attention to detail, organizational skills, and excellent communication skills.Knowledge of Vascular Interventional Cardiology and/or Peripheral Vascular Intervention is advantageous.SPECIALIZED SKILLS & OTHER REQUIREMENTS:Strong knowledge of MDR, ISO 14155, ICH/GCP guidelines, with a focus on compliance.Ability to train and mentor staff for remote and on-site monitoring.Ability to work independently and manage time effectively.Proficient in medical terminology, MS Word, Excel, and database applications.Responsible home office setup to support work responsibilities.#J-18808-Ljbffr