Senior Clinical Research Associate

Social network you want to login/join with:Senior Clinical Research Associate, asticol-narrow-leftClient:TeleflexLocation:Job Category:Other-EU work permit required:Yescol-narrow-rightJob Reference: Job Views:2Posted: Expiry Date: col-wideJob 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 incl. 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 Teleflex Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits and proactively provides input on site performance.Adequately prepares for monitoring visits to ensure monitoring activities are organized, well planned, efficient and thorough. Prepares site email 1-2 weeks prior to on-site and remote monitoring visits. Re-evaluates time necessary for on-site visits. Maximizes time on-site through visit preparation.Conducts monitoring visits per the department SOP, WIs and monitoring plans. Applies MDR, ISO 14155, ICH/GCP guidelines and Teleflex SOP and WIs to monitoring activities.Completes the Investigator Files with all appropriate documentation. Ensures all required documentation is completed prior to site initiation, during enrolment and follow-up, and at site close out.Presents findings to site staff. Provides clear directions for resolution. Provides appropriate retraining. Reviews data queries with site staff to ensure they are understood and can be resolved.Serves as a resource to clinical site staff between visits to provide clarification and insights regarding data queries, action items and visit preparation.Completes professional, accurate and succinct Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters per Teleflex procedures.Professionally documents monitoring visit action items. Action items will clearly identify the issue and suggest accurate instructions for resolution.Collect necessary documents and contribute to document filing.Ensures compliance with national and local safety reporting requirements.Collect information of local safety reporting requirements and report to Saftey Officer (SO) at pre-defined timepointsPrepare national safety related submission documents to EC / NCA upon request by SOBe contact for national EC(s) and NCA regarding safety reporting upon request by SOSubmission of local safety documentation to EC / NCA upon request by SOFollow up with study sites of Safety/Adverse event related tasks upon request by SOEnsuring that national / local requirements are met in respect to safety-related documents used and in respect to safety event reporting processesCo