Senior In-House Clinical Research Associate — Remote

Cabaletta Bio; Kentucky; On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Stock options

Paid time off

Benefits package

Job summary

Cabaletta Bio in the United States is seeking a Senior In-House Clinical Research Associate to support 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 Operations to ensure high-quality trial conduct and inspection-ready documentation throughout the study lifecycle.

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 travel up to 10%.

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

Communication skills

Attention to detail

Organizational skills

Team player

Adaptability

Problem solving

Education

Bachelor's or Master's degree in life sciences/nursing/pharmacy

Tools

EDC systems

Microsoft Office

Job description

Cabaletta Bio in the United States is seeking a Senior In-House Clinical Research Associate to support 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 Operations to ensure high-quality trial conduct and inspection-ready documentation throughout the study lifecycle.