Senior Clinical Research Associate

OverviewPOSITION 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.CultureCustomer 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 ResponsibilitiesConducts 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 Safety Officer (SO) at pre-defined timepoints. Prepare national safety related submission documents to EC / NCA upon request by SO. Be contact for national EC(s) and NCA regarding safety reporting upon request by SO.Submission of local safety documentation to EC / NCA upon request by SO. Follow up with study sites of Safety/Adverse event related tasks upon request by SO.Ensuring that national / local requirements are met in respect to safety-related documents used and in respect to safety event reporting processes.Collect local data protection requirement information and report to CPM prior to study start.Assists the Clinical Project Manager in the department and in study related projects as requested including in-house audits, investigator meetings, training, etc.Conducts co-monitoring with Clinical Studies personnel to confirm monitoring is conducted consistently with the protocol, department SOP, WIs and monitoring plans and regulatory standards.Oversee training of newly hired Clinical Studies personnel. Provide leadership to the RCRA Group performing day-to-day responsibilities for clinical studies.Support in adapting the applicable WIs and Guidelines in accordance to necessary regulations.Preparation and support during safety inspections and audits by regulatory authorities.Conducts 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. Provide 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.Performs remote monitoring as per monitoring plans and department needs within the established timelines and follows queries to resolution.Interfaces with Medical Affairs, Sales and administrative staff as necessary to accomplish the above responsibilities.Complies with the Teleflex Travel Policy. Completes and submits accurate expense reports.Provides input to Medical Affairs, Sales and Administrative Departments as necessary to accomplish the above responsibilities.Manage and assist eCRF completion, data query resolution within study guidelines.Participate in the study team and assist on development of conference calls with site staff, FAQs, and other study documents.Education / Experience RequirementsBachelor’s or higher-level degree in life sciences, nursing or other health related disciplines or have a comparable qualification. Knowledge of the medical device sector. A minimum of 5 years’ on-site monitoring research experience as a CRA in the medical device or pharmaceutical industry or with a CRO. High level of attention to detail and strong organizational ability paired with excellent people skills. Excellent clinical trial monitoring skills. Previous knowledge of Vascular Interventional Cardiology and/or Peripheral Vascular Intervention is an advantage.Specialized Skills & Other RequirementsStrong working knowledge, understanding and ability to apply MDR, ISO 14155 and ICH/GCP guidelines governing clinical trials. Strong compliance focus.Demonstrated aptitude and knowledge in relevant therapeutic areas and ability to learn and integrate new therapeutic areas knowledge.Ability to train and mentor Clinical Studies personnel for remote and on-site monitoring visits. Ability to train on site staff on the protocol, GCPs, data entry and other pertinent regulations.Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands with sites and study teams.High attention to detail and accuracy.Experience working independently in a regional area with remote or minimal supervision.Proficient knowledge of medical terminology.Effective time management and organizational skills.Excellent professional writing and oral communication skills.Excellent interpersonal skills.Experience with spreadsheets, and databases applications (e.g., MS Word and Excel).Ability to work independently within Teleflex systems.Ability to work independently and as a part of a team.Responsible for adequate and reasonable home office setting including dedicated desk space to accommodate work responsibilities and Teleflex supplied equipment.Fluent (written and spoken) in Italian.Fluent (written and spoken) in English.If necessary, international travel.Travel RequiredUp to 70%.#J-18808-Ljbffr