Senior In-House Clinical Research Associate

Senior In-House Clinical Research Associate Remote Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit cabalettabio. com and connect with us on LinkedIn. Uniquely Differentiated. Rapid. Elegant. At Cabaletta, we are driven by the mission of developing cures, where a patient’s own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We’re proud to be a Great Place to Work-Certified™ company!

#GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work® Position Description: This role can be remote or based out of our Philadelphia, PA headquarters . The Senior In-House Clinical Research Associate (CRA) supports the planning, execution, and oversight of Cabaletta Bio’s clinical trials, serving as a key operational and external-facing partner to clinical sites, CROs, and other vendors. This role works cross-functionally with Clinical Project Management and the broader Clinical Operations team to ensure high-quality trial conduct, strong site and vendor relationships, and inspection-ready documentation throughout the study lifecycle. This role will play a key part in bringing complex studies forward in a fast-paced, mission-driven environment. This role will report to the Senior Clinical Trial Manager/Associate Director Clinical Operations. Key Responsibilities - Provide monitoring oversight by reviewing monitoring reports and escalating any trends related to data quality or study conduct to the appropriate CTM, Clinical Operations. - Support the oversight of activities of CRO and study vendors to ensure compliance with the study protocol and on-time achievement of overall clinical objectives and deliverables. - Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, study plans and CRFs. - Contribute to and partner with the CRO for study start-up activities including site feasibility and selection. - Support the Clinical Operations team and cross-functional representatives as required in relationship management tasks (e. g. , study logistics, patient enrollment, safety, data management, etc. ) to accurately coordinate clinical study activities. - Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies. - Collaborate with Clinical, Regulatory, Quality, and other cross functional team members to ensure compliance and inspection readiness. - Identify and resolve study-related issues and deviations, as needed. - Communicate with study sites and investigators.