Senior Clinical Research Associate

📋 Description

• Independently manage and support study start-up activities for multi-center clinical trials
• Perform or support on-site feasibility, Site Initiation, Interim Monitoring, and Close-Out Visits
• Provide ongoing monitoring oversight and review monitoring schedules, performance metrics, reports
• Support clinical site training and monitor adherence to study protocols, ICH/GCP guidelines
• Lead or participate in the management of clinical study vendors
• Perform routine in-house data listing reviews

🎯 Requirements

• BS/BA, RN, or equivalent qualification with at least 4 years of clinical trial monitoring
• 8+ years of clinical operations experience; solid tumors or cell therapy experience strongly
• Strong knowledge of ICH/GCP guidelines, clinical drug development processes, protocols, study
• Experience managing clinical studies from early through late development phases, working with CROs
• Excellent written and verbal communication, interpersonal, administrative, organizational
• Strong decision-making, troubleshooting, problem-solving, analytical, prioritization abilities

🎁 Benefits

• Annual base salary of $130,000–$150,000 USD
• Remote work environment
• Opportunities to contribute to innovative clinical development programs in solid tumors and cell
• Exposure to multi-center and global clinical trials, CRO and vendor management
• Opportunities to develop expertise across full clinical trial lifecycle
• Collaboration with experienced clinical, medical, data, vendor, operational professionals