Cabaletta Bio · 9 hours ago
Sr. In-House Clinical Research Associate
All, MO
Full-time
Hybrid
Mid, Senior Level
2+ years expCabaletta Bio is a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases. The Senior In-House Clinical Research Associate supports the planning, execution, and oversight of clinical trials, ensuring high-quality trial conduct and strong relationships with clinical sites, CROs, and vendors.
BiotechnologyHealth CareMedicalRoboticsTherapeutics
Responsibilities
Provide monitoring oversight by reviewing monitoring reports and escalate any trends with respect to data quality or study conduct to the appropriate CTM, Clinical Operations
Perform clinical research site activities, such as onsite or remote co-monitoring, training, motivational, and sponsor oversight visits, as needed
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 study start-up activities including site 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, and Quality team members to ensure compliance of study activities
Identify and resolve study-related issues and deviations
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 other duties and assignments as required for the overall success of the projects
Qualification
Required
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, and monitoring
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
Preferred
Experience in a startup setting is preferred
Ability to travel up to 10%, if needed
Benefits
Competitive benefits
PTO
Stock option plans
Company
Cabaletta Bio
Cabaletta Bio has adapted clinically-validated and FDA-approved CAR T cell technology to target B cell-mediated autoimmune diseases.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$310MKey Investors
5AM Ventures
2025-06-11Post Ipo Equity· $100M
2023-05-17Post Ipo Equity· $87M
2022-12-08Post Ipo Equity· $35M
Leadership Team
Samik Basu
Chief Scientific Officer
Steve Gavel
Chief Commercial Officer
Recent News
GlobeNewswire
2026-01-12
2025-12-11
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