Senior In-House Clinical Research Associate

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🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Cabaletta Bio

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2017

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Cabaletta Bio is a clinical-stage biotechnology company developing engineered T cell therapies to treat autoimmune diseases. Using its CABA® (Cabaletta Approach to B cell Ablation) platform, the company is advancing rese-cel, a fully human CD19 CAR T cell candidate with a 4-1BB co-stimulatory domain, in multiple RESET™ Phase 1/2 trials for systemic lupus erythematosus, myositis, systemic sclerosis, generalized myasthenia gravis, and pemphigus vulgaris. Cabaletta aims to deliver deep, durable, potentially curative responses by transiently eliminating B cells to reset immune tolerance, and emphasizes patient-centered development and broad indication expansion across rheumatology, dermatology, and neurology.

📋 Description

• Provide monitoring oversight by reviewing monitoring reports and escalating data quality or study conduct trends • Oversee CRO and study vendor activities for protocol compliance and timely clinical objectives and deliverables • Contribute to study documentation, including protocols, study manuals, ICFs, study plans, and CRFs • Partner with CROs on study start-up, site feasibility, and site selection • Coordinate clinical study activities with Clinical Operations and cross-functional representatives • Maintain study documentation according to regulations, industry standards, and SOPs • Collaborate with Clinical, Regulatory, Quality, and other cross-functional teams for compliance and inspection readiness • Identify and resolve study-related issues and deviations • Communicate with study sites and investigators • Support study sites through training and troubleshooting • Schedule meetings and take minutes for Clinical Operations • Perform onsite or remote co-monitoring, training, motivational, and sponsor oversight visits as needed • Perform other duties supporting project success

🎯 Requirements

• 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 trial and site startup, 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 • Strong organizational skills for managing multiple tasks and priorities • Strong attention to detail for accurate data collection and documentation • Proficiency in Microsoft Office applications • Experience 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 • Startup experience preferred • Ability to travel up to 10%, if needed

🏖️ Benefits

• Competitive benefits • PTO • Stock option plans • Commitment to employee well-being and continuous growth • Great Place to Work-Certified™ company