Senior In-House Clinical Research Associate — Remote

Valid8 Financial, Inc.; Kentucky; On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive benefits

PTO

Stock option plans

Job summary

Cabaletta Bio is seeking a Senior In-House CRA to oversee monitoring of clinical trials, coordinate with sites, CROs, and vendors, and ensure inspection-ready documentation. This remote-friendly role reports to the Senior Clinical Trial Manager/Associate Director Clinical Operations and requires strong GCP, FDA, and ICH knowledge.

You will develop study materials, support site startup, manage communications with investigators, and travel up to 10% as needed, in a fast-paced, startup environment.

Qualifications

• Bachelor's or Master's degree in life sciences, nursing, or pharmacy.
• 2–3 years of clinical research experience.
• Experience with trial startup, site startup and vendor management.
• Strong knowledge of GCP, FDA regulations, and ICH guidelines.
• Excellent written and verbal communication skills.
• Proficiency with EDC systems preferred.
• Willingness to travel up to 10%.

Responsibilities

• Provide monitoring oversight by reviewing monitoring reports and escalating data quality or study conduct issues.
• Oversee CROs and vendors to ensure protocol compliance and timely deliverables.
• Contribute to development of study documents: protocol reviews, manuals, ICFs, plans, CRFs.
• Assist in site start-up activities including site feasibility and selection.
• Support Clinical Operations in study logistics, enrollment, safety, and data management.
• Maintain study documentation per regulations, standards, and SOPs.
• Collaborate with Clinical, Regulatory, Quality, and cross-functional teams for compliance.
• Identify and resolve study-related issues and deviations.
• Communicate with study sites and investigators.
• Provide training and troubleshooting support to sites.
• Assist with scheduling and minute-taking for team meetings.
• Perform site activities: co-monitoring, training, sponsor oversight visits as needed.
• Contribute to other duties for project success.

Skills

GCP knowledge

FDA regulations

ICH guidelines

Site monitoring

Vendor management

EDC software

Communication skills

Travel readiness

Education

Bachelor’s or Master’s degree in life sciences, nursing, or pharmacy

Tools

EDC software

Microsoft Office

Job description

Cabaletta Bio is seeking a Senior In-House CRA to oversee monitoring of clinical trials, coordinate with sites, CROs, and vendors, and ensure inspection-ready documentation. This remote-friendly role reports to the Senior Clinical Trial Manager/Associate Director Clinical Operations and requires strong GCP, FDA, and ICH knowledge.

You will develop study materials, support site startup, manage communications with investigators, and travel up to 10% as needed, in a fast-paced, startup environment.