Senior Clinical Research Associate

Social network you want to login/join with:Senior Clinical Research Associate, pescaraClient: TeleflexLocation: Pescara, 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 required by review of 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, provide problem solving strategies 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 in order to strengthen the Teleflex brand and relationship 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 – Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data.PRINCIPAL RESPONSIBILITIES:Conducts monitoring within timelines and according to the monitoring plan and Teleflex procedures.Works cooperatively with Research Coordinators and Investigators to schedule and conduct monitoring visits including site qualification, site initiation, routine monitoring and site closure visits.Evaluate quality and integrity of site practices while escalating quality issues as appropriate.Works cooperatively with the Clinical Studies project team to prepare for monitoring visits, escalate significant findings, and provide input on site performance.Prepares for monitoring visits to ensure activities are organized, well planned, efficient, and thorough. Re-evaluates time necessary for visits and maximizes on-site time through preparation.Conducts monitoring visits per SOP, WIs, and monitoring plans, applying MDR, ISO 14155, ICH/GCP guidelines, and Teleflex procedures.Completes Investigator Files with all documentation, ensuring completeness at all study phases.Presents findings to site staff, providing clear directions for resolution and retraining as needed. Reviews data queries with site staff.Serves as a resource between visits for clarification and insights.Completes Monitoring Visit Reports accurately and professionally, documenting action items clearly.Collects documents and contributes to filing.Ensures compliance with safety reporting requirements, reports to Safety Officer, and prepares submission documents.Coordinates safety and adverse event reporting with study sites and authorities.Gathers local data protection information and reports to CPM.Assists in audits, investigator meetings, and training.Conducts co-monitoring with Clinical Studies personnel.Oversees training of new personnel and supports in updating WIs and guidelines.Prepares for inspections and audits.Trains site staff on protocol, GCP, and regulations.Performs remote monitoring within plans and timelines, following up on queries.Interfaces with Medical Affairs, Sales, and admin staff as needed.Completes expense reports and manages eCRF and data queries.Participates in study team activities and develops study documents.EDUCATION / EXPERIENCE REQUIREMENTS:Bachelor’s or higher 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 in medical devices, pharma, or CRO.Strong attention to detail, organizational, and interpersonal skills.Excellent clinical monitoring skills.Knowledge of Vascular Interventional Cardiology and/or Peripheral Vascular Intervention is advantageous.SPECIALIZED SKILLS & OTHER REQUIREMENTS:Strong understanding of MDR, ISO 14155, ICH/GCP guidelines.Aptitude to learn new therapeutic areas.Ability to train and mentor staff and site personnel.Ability to maintain composure and adapt to shifting priorities.High accuracy and detail orientation.Experience working independently in a regional area.Proficiency in medical terminology, MS Office, and database applications.Ability to work independently and as part of a team.Responsible for a suitable home office setup.#J-18808-Ljbffr