Clinical Research Associate

About the role

Senseonics is looking for a Clinical Research Associate to support the execution of clinical studies for its diabetes care technology. The company focuses on long-term, implantable continuous glucose monitoring solutions designed to improve life for people with diabetes and to support the clinicians who care for them. This role sits within a team that values innovation, accountability, customer focus, and fast, collaborative problem-solving.

The position is centered on ensuring that clinical trials are run properly, study data is accurate and complete, and all activities comply with study protocols, federal requirements, ICH and GCP standards, and applicable local rules.

Key responsibilities

• Plan and carry out the activities needed to manage clinical trials while maintaining compliance with GCP, ICH guidance, FDA rules, MDR requirements, SOPs, and study protocols.
• Take responsibility for completeness and accuracy of study data.
• Support clinical sites with IRB/EC submissions, contract discussions, enrollment tracking, clinical supply and material requests, and issue resolution.
• Visit study sites regularly throughout the trial, both within the United States and internationally, as needed.
• Provide training to clinic sites on correct product handling and use, including hands-on instruction for sensor insertion and removal.
• Perform and coordinate on-site and remote monitoring visits and support subject visits to confirm protocol adherence.
• Serve as the main point of contact between the sponsor and investigators across multiple studies and sites.
• Guide and develop junior CRAs and Clinical Trial Assistants by supporting their training and professional growth.
• Maintain Trial Master Files and keep assigned sites ready for audits.
• Help with feasibility assessment, site selection, and vendor oversight, including tracking enrollment performance and study budgets.
• Coordinate with external partners such as CROs, central labs, IRBs, and other contractors.
• Assist commercialization efforts by helping create clinical training and education content for product use.

Required qualifications

• A minimum 4-year undergraduate degree in Natural Sciences or Engineering is required; a graduate degree in the same area is preferred.
• At least 1 to 3 years of practical experience in Clinical Sciences is required.
• Prior experience in the implantable medical device space is preferred.
• Strong analytical, communication, and organizational abilities are needed.
• Proficiency with Microsoft Office and CTMS/EDC systems is required.
• Strong writing ability, including experience preparing clinical trial reports, is expected.
• Ability to travel extensively, around 50% to 60%, including domestic and international trips, often on short notice.
• Working knowledge of clinical GCP requirements, FDA expectations, AIMDD, ISO 14155, and related standards is required.

About Senseonics

Senseonics is a medical technology company focused on transforming diabetes management through long-term implantable continuous glucose monitoring systems. The organization is committed to delivering technology that creates meaningful impact for patients and healthcare professionals.

Additional information

This is a full-time remote role based in the United States.