Senior Clinical Research Associate

📋 Description

• Provide logistical support for clinical study operations from start-up to close-out
• Develop study documents (protocol, informed consent, training materials, amendments, monitoring plans)
• Manage contracting, budget, invoicing for vendors and sites
• Support data management with CRF design and EDC testing
• Train CROs, vendors, investigators and study coordinators on study requirements
• Monitor trial progress and provide status updates to stakeholders

🎯 Requirements

• BA/BS degree in life sciences or related field
• Minimum 4 years of clinical studies experience (academic, biopharma, diagnostics, or medical device)
• Experience with clinical EDC systems
• Familiarity with Trial Master File (TMF) structure
• Competence in SOPs, ICH-GCP, FDA Regulations
• Proficiency in MS Word, Excel, PowerPoint

🎁 Benefits

• Comprehensive medical, dental, vision, life and disability plans
• Fertility care benefits for employees and families
• Pregnancy and baby bonding leave
• 401k retirement plan with company match
• Commuter benefits and employee referral program