[Remote] Regional Clinical Research Associate (REMOTE)

Note: The job is a remote job and is open to candidates in USA. Teleflex is a global provider of medical technologies aiming to improve health and quality of life. The Regional Clinical Research Associate will be responsible for conducting monitoring visits and ensuring compliance with regulatory standards for clinical studies in vascular intervention and other therapeutic areas.ResponsibilitiesConduct assigned monitoring activities in accordance with Teleflex procedures and applicable regulations to evaluate protocol compliance, data accuracy, and subject safety by review of regulatory documents, medical records, reported data, and device storage, if applicableResponsible for all monitoring activities for assigned clinical studies, including:Scheduling and conducting monitoring activities onsite or remote within specified timelines and according to the risk-based monitoring plan and Teleflex proceduresIdentification of data discrepancies and compliance concerns, present findings to site research 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 reportWorks collaboratively with Research Coordinators and Investigators to conduct monitoring visits, provide retraining, and resolve compliance concerns as appropriateWorks 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 performancePresents findings to site staff and provides clear directions for resolution. Reviews data queries with site staff to confirm understanding and resolutionServes as a resource to site staff between monitoring visits to provide clarification and insights regarding data queries, action items, and study visit preparationTrains and mentors Teleflex personnel on monitoring procedures and practicesConducts site training and co-monitoring visits as requested by managementCompletes monitoring visit reports, action items, and monitoring visit follow-up letters per Teleflex proceduresAssists with team, department, and study-related projects as requested, including audits, investigator meetings, training, etcInterfaces with Clinical, Regulatory, Sales, and clinical site staff as necessary to accomplish the above responsibilitiesSkillsBachelor's or Graduate degree in life sciences, nursing, or other health-related disciplinesMinimum five years as a CRA in the medical device or pharmaceutical industry or with a CRODemonstrated aptitude and knowledge in relevant therapeutic areaStrong compliance focus and understanding of current GCP/ICH guidelines and FDA regulations specifically, 21 CFR Parts 11, 50, 54, 56, 812, and 820, ISO requirements governing medical device clinical trialsCurrent certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP)Strong knowledge of medical terminologyAbility to work independently in a regional area with minimal supervisionExcellent organizational and problem-solving skills, including demonstrated ability to evaluate challenging situations and develop alternative solutions creatively and independentlyExcellent interpersonal skills, ability to interface and communicate effectively with internal and external collaborators including physicians, site research staff, project teams and managementAbility to interact constructively in communication of adherence to protocol and regulatory requirementsResponsible for adequate and reasonable home office setup including dedicated desk space to accommodate work responsibilities and Teleflex-supplied equipmentVascular Interventional Cardiology experience conducting monitoring activities for first in human, investigational device exemption, post-approval and/or post-market studiesBenefitsBenefits such as medical, prescription drug, dental and vision insuranceFlexible spending accountsParticipation in 401(k) savings planVarious paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offeredDetails of participation in these benefit plans will be provided if an employee receives an offer of employmentCompany OverviewTeleflex is a manufacturing company that designs and develops medical devices for the healthcare sector. It was founded in 1943, and is headquartered in Wayne, Pennsylvania, USA, with a workforce of 10001+ employees. Its website is http://www.teleflex.com.