Clinical Research Associate

About Senseonics

Senseonics is a pioneering medical technology company focused on revolutionizing diabetes care with innovative implantable continuous glucose monitoring systems for long-term use. Our mission revolves around delivering transformative solutions that enable individuals living with diabetes, along with their healthcare providers, to manage the condition more effectively. As a team, we are committed to customer-centricity, bold innovation, continuous learning, and collaborative urgency to drive meaningful advancements in diabetes management.

Role Summary

The Clinical Research Associate will oversee clinical trial operations to ensure strict compliance with study protocols, U.S. federal regulations, International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), and local requirements governing clinical research. This position involves managing multiple aspects of clinical trials, including monitoring, coordination, and regulatory adherence, with opportunities to mentor junior staff and contribute to commercialization efforts.

Key Responsibilities

• Plan and execute clinical trial activities ensuring compliance with GCP, ICH, FDA, MDR, and company SOPs.
• Manage clinical site interactions such as Institutional Review Board (IRB) and Ethics Committee (EC) submissions, contract discussions, enrollment tracking, supply requests, and issue resolution.
• Conduct regular site visits—both domestic and international—to monitor trial progress and compliance.
• Train clinical site personnel on correct usage and operation of Senseonics products, including hands-on instruction for sensor insertion and removal.
• Perform on-site and remote monitoring visits, supporting subject visits to uphold protocol adherence.
• Serve as the principal communication link between the sponsor and multiple investigative sites for ongoing studies.
• Guide and support junior CRAs and Clinical Trial Assistants, contributing to their professional development and training.
• Maintain Trial Master Files (TMF) to ensure thorough documentation and readiness for audits.
• Support site feasibility assessments, selection processes, and vendor coordination, monitoring enrollment rates and study budgets.
• Oversee external partners’ activities including contract research organizations (CROs), central labs, IRBs, and other contractors.
• Assist in developing clinical training and educational materials to support the commercialization of Senseonics products.

Qualifications and Experience

• A minimum four-year undergraduate degree in Natural Sciences or Engineering is required; advanced degrees in related fields are preferred.
• At least 1–3 years of practical experience in clinical sciences is necessary.
• Prior exposure to the implantable medical device industry is desirable.
• Strong analytical, organizational, and communication capabilities are essential.
• Proficiency with Microsoft Office and clinical trial management systems (CTMS/EDC) is expected.
• Excellent written communication skills, including experience authoring clinical trial reports.
• Availability to undertake extensive travel (domestic and international) of approximately 50–60%, often on short notice.
• In-depth knowledge of clinical regulatory standards such as GCP, FDA, AIMDD, ISO 14155, and related guidelines.