Senior Clinical Research Associate

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🔥 12 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Luminate

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🏥 Healthcare

🤝 B2B

⚕️ Healthcare Insurance

Healthcare • B2B • Healthcare Insurance

Luminate is a healthcare company that builds technology-enabled services and clinical programs to deliver oncology infusion and supportive cancer care at home. The company partners with oncology clinics, health systems, and health plans to act as an integrated extension of existing providers—coordinating drug dispensing with the originating clinic, and delivering nurse-led, at-home chemotherapy and infusion services to reduce clinic burden, lower total cost of care, and improve patient experience. Luminate also develops medical-device technologies (pre-clinical/clinical-stage) and runs clinical trials to prevent treatment side effects and enable safe home-based oncology care.

📋 Description

• Act as the subject matter expert for Luminate Medical devices, serving as the primary point of contact between sponsor and site staff. • Manage and maintain essential study documents in compliance with sponsor requirements, study-specific processes, and Luminate SOPs. • Collaborate with internal and external clinical teams to support all phases of clinical trials, including study start-up, site initiation visits (SIVs), trial execution, and close-out. • Perform weekly check-ins with clinical sites to track progress, address issues, and provide ongoing support. • Contribute to departmental projects and initiatives, ensuring timely and high-quality deliverables. • Proactively identify and escalate training needs, project updates, quality concerns, and timeline risks to the clinical team.

🎯 Requirements

• Bachelor’s degree in Life Sciences or a related field • 3 – 5 + years of hands-on experience within the medical device and/or pharmaceutical industry • Prior experience with Trial Master File (TMF) management • Prior experience and proficiency in utilizing Electronic Data Capture (EDC) systems • Deep understanding of GCP, ISO 14155, and FDA regulations for medical devices • Willingness and ability to travel 30-40% during active clinical trials period

🏖️ Benefits

• Flexible work arrangements