In-house Clinical Research Associate

• Support clinical operations across multiple studies while ensuring subject safety and data integrity
• Review and maintain the electronic Trial Master File (eTMF) in compliance with SOPs, GCP, and ICH guidelines
• Support study start-up and ongoing trial activities, including regulatory documentation and site readiness
• Serve as a liaison between internal teams, CROs, vendors, and investigator sites
• Review monitoring visit reports (PSV, SIV, IMV, COV)
• Remotely track enrollment and treatment status using IxRS and EDC systems
• Maintain study tracking tools, meeting minutes, and action items
• Participate in investigator meetings, study training, and co-monitoring activities as needed
• Perform duties in compliance with FDA regulations, ICH-GCP, and company policies

• Bachelor’s degree preferred
• 3 years of experience
• Experience as an unblinded CRA required
• Min. 2 years of experience with site management and CRO/vendor oversight
• Prior biotech or pharmaceutical industry experience required
• Proficiency with Microsoft Office and Veeva eTMF required
• Smartsheet and SharePoint a plus
• Strong organizational skills, attention to detail, and ability to manage multiple priorities
• Working knowledge of clinical trials and drug development (Phase I–III)

Smartsheet and SharePoint a plus

• medical
• dental
• vision
• 401(k)
• telehealth services
• ESOP
• commuter benefits