[Hiring] Senior In-House Clinical Research Associate @Cabaletta Bio

Role Description

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.

• 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

• A bachelor's or master's degree in a relevant field, such as life sciences, nursing, or pharmacy.
• At least 2-3 years of experience in clinical research, preferably in a CRA or related role.
• Experience with all aspects of trial and site startup and vendor selection and management, study management, monitoring and study close-out.
• Strong knowledge of clinical trial conduct, GCP, FDA regulations, and ICH guidelines.
• Excellent written and verbal communication skills to effectively communicate with study sites, investigators, and internal study team members.
• Strong organizational skills to manage multiple tasks and priorities simultaneously.
• Strong attention to detail to ensure accurate and complete data collection and documentation.
• Proficiency in Microsoft Office applications and experience working with electronic data capture systems (EDC).
• Ability to build positive relationships with study sites and investigators.
• Flexibility to adapt to changing project needs and timelines.
• Strong team orientation and passion for continuous self-development.
• Experience in a startup setting is preferred.
• Ability to travel up to 10%, if needed.

Benefits

• Competitive benefits.
• PTO.
• Stock option plans.

Company Description

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.

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.