[Remote] Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. Senseonics is a medical technology company dedicated to transforming diabetes management through long-term, implantable continuous glucose monitoring systems. The Clinical Research Associate will be responsible for the overall clinical study conduct of clinical trials to ensure compliance with protocol(s) and Federal regulations, ICH and GCPs, and local requirements.ResponsibilitiesResponsible for planning and implementing activities required to manage clinical trials and ensures adherence to Good Clinical Practices (GCP), ICH guidelines, FDA regulations, MDR requirements, SOPs, and protocols; take ownership for data completion and accuracyContribute to clinical site interactions, including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and supply requests, issue resolution, etcConduct frequent site visits as required throughout the duration of the study, international and domesticTrain clinic sites on proper product use and operation, including hands on training on sensor insertion and removalPerform and manage all on-site and remote monitoring visits as well as support subject study visits to ensure site protocol complianceAct as the primary liaison between the sponsor and investigators for multiple sites and studiesCoach and mentor junior CRAs (CRA I/II) and Clinical Trial Assistants (CTAs), assisting in their training and developmentMaintain Trial Master Files (TMF) and ensure audit readiness of assigned sitesAssist with study feasibility, site selection, and vendor management, including tracking enrollment rates and study budgetsEffectively manage external team/vendors activities including CRO,central lab,IRB and other external contractorsSupport commercialization efforts by assisting in the development of clinical training and education materials related to the use of the productSkillsMust have a minimum 4-year undergraduate degree in Natural Sciences or EngineeringMust have a minimum of 1-3 years of applied experience in Clinical SciencesStrong analytical, communication, and organizational skills, along with proficiency in Microsoft Office and CTMS/EDC systemsStrong writing skills, experience with clinical trial report writingMust be able to travel extensively, 50-60 % (domestic and international), many times on short noticeWell-versed in clinical aspects of GCP, FDA, AIMDD, ISO 14155 and other relevant experiencesPreferred is a graduate degree in same disciplinesPreferred experience in implantable medical device industryCompany OverviewAt Senseonics, we are dedicated to improving the lives of people with diabetes through long-term continuous glucose monitoring (CGM) technology. It was founded in 1996, and is headquartered in Germantown, Maryland, USA, with a workforce of 201-500 employees. Its website is http://senseonics.com.Company H1B SponsorshipSenseonics, Incorporated has a track record of offering H1B sponsorships, with 2 in 2026, 2 in 2025, 10 in 2024, 3 in 2023, 5 in 2022, 3 in 2021, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role.