Senior In-House Clinical Research Associate
Cabaletta Bio
August 18, 2026
Remote friendly (All, MO)
United States
Clinical Research and Development
Position Description
- This role can be remote or based out of Philadelphia, PA headquarters.
Key Responsibilities
- Provide monitoring oversight by reviewing monitoring reports and escalating trends related to data quality or study conduct.
- Support oversight of CRO and study vendors to ensure protocol compliance and timely achievement of clinical objectives and deliverables.
- Contribute to study documentation (protocol review, study manuals, ICFs, study plans, CRFs).
- Partner with the CRO on study start-up activities including site feasibility and selection.
- Support Clinical Operations relationship management (e.g., study logistics, patient enrollment, safety, data management).
- Ensure study documentation is maintained per applicable regulations, industry standards, and SOPs.
- Collaborate cross-functionally (Clinical, Regulatory, Quality, etc.) to ensure compliance and inspection readiness.
- Identify and resolve study issues and deviations.
- Communicate with study sites and investigators; provide site support (training and troubleshooting).
- Support administrative tasks (scheduling meetings, taking minutes).
- Perform clinical research site activities as needed (onsite/remote co-monitoring, training, sponsor oversight visits).
- Perform other duties as required.
Qualifications
- Bachelor’s or master’s degree in a relevant field (life sciences, nursing, pharmacy).
- 2–3+ years clinical research experience (preferably CRA or related).
- Experience across trial/site startup, vendor selection/management, study management, monitoring, and study close-out.
- Strong knowledge of clinical trial conduct, GCP, FDA regulations, and ICH guidelines.
- Excellent written/verbal communication; strong organizational skills; strong attention to detail.
- Proficiency in Microsoft Office and experience with EDC.
- Ability to build relationships with sites/investigators; flexibility to adapt to changing needs.
- Startup experience preferred.
- Ability to travel up to 10% if needed.
Application Instructions
- Visit https://www.cabalettabio.com/join-our-crew
- This role can be remote or based out of Philadelphia, PA headquarters.
Key Responsibilities
- Provide monitoring oversight by reviewing monitoring reports and escalating trends related to data quality or study conduct.
- Support oversight of CRO and study vendors to ensure protocol compliance and timely achievement of clinical objectives and deliverables.
- Contribute to study documentation (protocol review, study manuals, ICFs, study plans, CRFs).
- Partner with the CRO on study start-up activities including site feasibility and selection.
- Support Clinical Operations relationship management (e.g., study logistics, patient enrollment, safety, data management).
- Ensure study documentation is maintained per applicable regulations, industry standards, and SOPs.
- Collaborate cross-functionally (Clinical, Regulatory, Quality, etc.) to ensure compliance and inspection readiness.
- Identify and resolve study issues and deviations.
- Communicate with study sites and investigators; provide site support (training and troubleshooting).
- Support administrative tasks (scheduling meetings, taking minutes).
- Perform clinical research site activities as needed (onsite/remote co-monitoring, training, sponsor oversight visits).
- Perform other duties as required.
Qualifications
- Bachelor’s or master’s degree in a relevant field (life sciences, nursing, pharmacy).
- 2–3+ years clinical research experience (preferably CRA or related).
- Experience across trial/site startup, vendor selection/management, study management, monitoring, and study close-out.
- Strong knowledge of clinical trial conduct, GCP, FDA regulations, and ICH guidelines.
- Excellent written/verbal communication; strong organizational skills; strong attention to detail.
- Proficiency in Microsoft Office and experience with EDC.
- Ability to build relationships with sites/investigators; flexibility to adapt to changing needs.
- Startup experience preferred.
- Ability to travel up to 10% if needed.
Application Instructions
- Visit https://www.cabalettabio.com/join-our-crew