[Remote] Senior In-House Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. Cabaletta Bio is a clinical-stage biotechnology company developing cell therapies for autoimmune diseases. The Senior In-House Clinical Research Associate supports clinical trial planning, execution, and oversight, partnering with clinical sites, CROs, vendors, and internal teams to support quality trial conduct and inspection-ready documentation.

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

Skills

• 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
• 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
• Preferably in a CRA or related role
• Experience in a startup setting is preferred

Benefits

• This role can be remote or based out of our Philadelphia, PA headquarters.
• PTO
• Stock option plans

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