PstronguPOSITION SUMMARY /u /strong: /ppbr/ppThe 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. /ppbr/ppstronguCULTURE: /u /strong /ppCustomer Experience – Representing Teleflex in a customer facing position is a tremendous responsibility and opportunity. /pp 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. /pp 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. /pp 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. /ppbr/ppstronguPRINCIPAL RESPONSIBILITIES /u /strong: /ppbr/pulliConducts monitoring within timelines and according to the monitoring plan and Teleflex procedures. /liliWorks cooperatively with Research Coordinators and Investigators to schedule and conduct monitoring visits incl. site qualification, site initiation, routine monitoring and site closure visits. /liliEvaluate quality and integrity of site practices while escalating quality issues as appropriate. /liliWorks 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. /liliAdequately 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. /liliConducts 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. /liliCompletes 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. /liliPresents 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. /liliServes as a resource to clinical site staff between visits to provide clarification and insights regarding data queries, action items and visit preparation. /liliCompletes professional, accurate and succinct Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters per Teleflex procedures. /liliProfessionally documents monitoring visit action items. Action items will clearly identify the issue and suggest accurate instructions for resolution. /liliCollect necessary documents and contribute to document filing. /liliEnsures compliance with national and local safety reporting requirements. /liliCollect information of local safety reporting requirements and report to Saftey Officer (SO) at pre-defined timepoints /liliPrepare national safety related submission documents to EC / NCA upon request by SO /liliBe contact for national EC(s) and NCA regarding safety reporting upon request by SO /liliSubmission of local safety documentation to EC / NCA upon request by SO /liliFollow up with study sites of Safety/Adverse event related tasks upon request by SO /liliEnsuring that national / local requirements are met in respect to safety-related documents used and in respect to safety event reporting processes /liliCollect local data protection requirement information and report to CPM prior to study start /liliAssists the Clinical Project Manager in the department and in study related projects as requested including in-house audits, investigator meetings, training, etc. /liliConducts co-monitoring with Clinical Studies personnel to confirm monitoring is conducted consistently with the protocol, department SOP, WIs and monitoring plans and regulatory standards. /liliOversee training of newly hired Clinical Studies personnel. Provide leadership to the RCRA Group performing day-to-day responsibilities for clinical studies. /liliSupport in adapting the applicable WIs and Guidelines in accordance to necessary regulations. /liliPreparation and support during safety inspections and audits by regulatory authorities. /liliConducts training visits with Clinical Studies personnel to train and mentor individuals on conducting monitoring consistent with the protocol, department SOP, WIs and monitoring plans and regulatory standards. /liliProvide training of site to protocol requirements. Develop and oversee training for general research and site management. May conduct ongoing general training calls with site staff per study needs. /liliPerforms remote per monitoring plans and department needs within the established timelines and follows queries to resolution. /liliInterfaces with Medical Affairs, Sales and administrative staff as necessary to accomplish the above responsibilities. /liliComplies with the Teleflex Travel Policy. Completes and submits accurate expense reports. /liliProvides input to Medical Affairs, Sales and Administrative Departments as necessary to accomplish the above responsibilities. /liliManage and assist eCRF completion, data query resolution within study guidelines. /liliParticipate in the study team and assist on development of conference calls with site staff, FAQs, and other study documents. /li /ulpbr/ppbr/ppstronguEDUCATION / EXPERIENCE REQUIREMENTS /u /strong: /p ulliBachelor’s or higher-level degree in life sciences, nursing or other health related disciplines or have a comparable qualification. /liliKnowledge of the medical device sector. /liliA minimum of 5 years’ on-site monitoring research experience as a CRA in the medical device or pharmaceutical industry or with a CRO. /liliHigh level of attention to detail and strong organizational ability paired with excellent people skills. /liliExcellent clinical trial monitoring skills. /liliPrevious knowledge of Vascular Interventional Cardiology and/or Peripheral Vascular Intervention is an advantage. /li /ulpbr/ppbr/ppstronguSPECIALIZED SKILLS OTHER REQUIREMENTS /u /strong: /ppbr/pulliStrong working knowledge, understanding and ability to apply MDR, ISO 14155 and ICH/GCP guidelines governing clinical trials. Strong compliance focus. /liliDemonstrated aptitude and knowledge in relevant therapeutic areas and ability to learn and integrate new therapeutic areas knowledge. /liliAbility to train and mentor Clinical Studies personnel for remote and on-site monitoring visits. /liliAbility to train on site staff on the protocol, GCPs, data entry and other pertinent regulations. /liliDemonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands with sites and study teams. /liliHigh attention to detail and accuracy. /liliExperience working independently in a regional area with remote or minimal supervision. /liliProficient knowledge of medical terminology. /liliEffective time management and organizational skills. /liliExcellent professional writing and oral communication skills. /liliExcellent interpersonal skills. /liliExperience with spreadsheets, and databases applications (e.g., MS Word and Excel) /liliAbility to work independently within Teleflex systems. /liliAbility to work independently and as a part of a team. /liliResponsible for adequate and reasonable home office setting including dedicated desk space to accommodate work responsibilities and Teleflex supplied equipment. /liliFluent (written and spoken) in Italian. /liliFluent (written and spoken) in English. /liliIf necessary, international travel. /li /ulpbr/ppstronguTRAVEL REQUIRED /u /strong: Up to 70%. /p