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Senior Clinical Research Associate

11 ore fa

Chieti, Italia Jr Italy A tempo pieno

Social network you want to login/join with:Senior Clinical Research Associate, ChietiClient:TeleflexLocation:Chieti, ItalyJob Category:Other-EU 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 *****, ICH/GCP guidelines, Teleflex procedures, and IRB/EC policies).They evaluate data accuracy and subject safety, identify issues, present findings, and communicate with the study team.The Senior CRA should have at least 5 years of experience in clinical trial monitoring and assist with training and development of monitoring tools.CULTURE:Teleflex emphasizes Customer Experience, Continuous Improvement, and adherence to company Values.Employees are expected to demonstrate professionalism, ethics, and effective cross-functional collaboration.PRINCIPAL RESPONSIBILITIES:Conduct monitoring visits according to plans and procedures.Coordinate with research staff for site visits and evaluations.Ensure compliance and quality of site practices.Prepare for visits, document findings, and provide training as needed.Ensure regulatory compliance and proper documentation.Support safety reporting and regulatory submissions.Assist in training new staff and conducting audits.Participate in study team activities and maintain proper documentation.EDUCATION / EXPERIENCE REQUIREMENTS:Bachelor's degree in life sciences, nursing, or related fields.Minimum 5 years of CRA experience in medical device or pharmaceutical industry.Knowledge of vascular interventional therapies is a plus.SPECIALIZED SKILLS & OTHER REQUIREMENTS:Strong knowledge of MDR, ISO *****, ICH/GCP guidelines.Excellent monitoring, training, and communication skills.Ability to work independently and manage time effectively.#J-*****-Ljbffr