Senior In-House Clinical Research Associate

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. 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. • Provide support to study sites, including training and troubleshooting. • Support various administrative tasks for the Clinical Operations team including scheduling meetings and taking minutes. • Perform clinical research site activities, such as onsite or remote co-monitoring, training, motivational, and sponsor oversight visits, as needed. • Perform other duties and assignments as required for the overall success of the projects. Qualifications: