Senior Clinical Research Associate
2 settimane fa
Social network you want to login/join with:Senior Clinical Research Associate, CasertaClient: TeleflexLocation: Caserta, 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). 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.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 to improve results.Culture and Values – Embodies Teleflex values, ensuring a fair, open, and productive environment. Collaborates effectively across functions and ensures materials are processed accurately based on clinical data and practice.PRINCIPAL RESPONSIBILITIES: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.Present findings clearly to site staff, providing guidance and retraining as necessary.Assist in safety reporting, including collecting documentation and reporting adverse events to authorities.Support training of clinical staff and conduct audits and inspections.Participate in study team activities, including meetings and document development.EDUCATION / EXPERIENCE REQUIREMENTS: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.SPECIALIZED SKILLS & OTHER REQUIREMENTS:Strong knowledge of MDR, ISO 14155, and ICH/GCP guidelines with a compliance focus.Ability to train and mentor staff and site personnel.Excellent communication, organizational, and time management skills.Proficiency with MS Word, Excel, and database applications.Ability to work independently and as part of a team, with a suitable home office setup.#J-18808-Ljbffr
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Senior Clinical Research Associate
6 ore fa
Caserta, Italia Jr Italy A tempo pienoSocial network you want to login/join with:Senior Clinical Research Associate, CasertaClient: TeleflexLocation: Caserta, ItalyJob Category: OtherEU work permit required: YesJob Reference: 8556790222002585600337147Job Views: 2Posted: **********Expiry Date: **********Job Description:POSITION SUMMARY:The Senior Clinical Research Associate (Senior CRA) is...
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Senior Cra — On-Site
6 ore fa
Caserta, Italia Jr Italy A tempo pienoA medical device company in Caserta seeks a Senior Clinical Research Associate to perform and oversee monitoring visits for clinical trials.The ideal candidate has over 5 years of relevant experience, strong organizational skills, and a solid knowledge of MDR and ICH/GCP guidelines.This role emphasizes customer experience and requires excellent communication...
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Senior CRA — On-Site
2 giorni fa
caserta, Italia JR Italy A tempo pienoA medical device company in Caserta seeks a Senior Clinical Research Associate to perform and oversee monitoring visits for clinical trials. The ideal candidate has over 5 years of relevant experience, strong organizational skills, and a solid knowledge of MDR and ICH/GCP guidelines. This role emphasizes customer experience and requires excellent...
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