Research Associate

2 settimane fa


Caserta CE, Italia JR Italy A tempo pieno

Social network you want to login/join with:Senior Clinical Research Associate, CasertaClient: TeleflexLocation: Caserta, ItalyJob Category: OtherEU work permit required: 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 per the monitoring plan and evaluates data accuracy and subject safety by reviewing regulatory documents, medical records, reported data, and device storage if applicable. The Senior CRA must identify issues, present findings, provide retraining if needed, and communicate with the study team and management. Candidates should have at least 5 years of experience as a clinical trial monitor. The Senior CRA also assists in training and developing monitoring tools and procedures.All colleagues are expected to perform professionally, ethically, and with high service standards to strengthen the Teleflex brand.Collaborates effectively across functions and ensures materials are processed accurately based on clinical data and practice.Conduct monitoring within timelines and according to plans and procedures.Coordinate with research staff to schedule and perform various monitoring visits.Evaluate site practices for quality and compliance, escalating issues as needed.Prepare for visits thoroughly, ensuring efficient and comprehensive monitoring activities.Perform monitoring visits following SOPs, WIs, and guidelines, ensuring compliance with MDR, ISO 14155, ICH/GCP, and Teleflex standards.Complete and maintain accurate documentation, including Investigator Files and Monitoring Visit Reports.Support training of clinical staff and conduct audits and inspections.Bachelor's degree or higher 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 the medical device or pharmaceutical industry.Strong attention to detail, organizational skills, and clinical monitoring expertise.Experience in Vascular Interventional Cardiology or Peripheral Vascular Intervention is advantageous.Ability to train and mentor staff and site personnel.Proficiency with MS Word, Excel, and database applications.Ability to work independently and as part of a team, with a suitable home office setup.
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