Senior Clinical Research Associate

🔥 14 minutes ago

🇺🇸 United States – Remote

💵 $99.4k - $124.2k / year

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 Description

• Provide high level logistical support for clinical study operations. • Develop study-related documents with minimal Clinical Trial Manager guidance. • Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors. • Support the Clinical Data Management team in the design and content of case report forms, including support and testing of an EDC. • Manage the preparation, handling, filing, and archiving of clinical documentation and reports. • Oversee clinical trial supplies related to biospecimen collection, processing, shipment, and storage. • Train CROs, vendors, investigators, and study coordinators on study requirements. • Monitor and track clinical trial progress, provide status updates to stakeholders. • Develop new study monitoring plans and monitor studies following those plans. • Perform study activities including consent participants for research studies. • Update Clinical Department SOPs with guidance from CTM and/or Director. • Partner with other research and development groups at Natera.

🎯 Requirements

• BA/BS degree in life sciences, related field, or equivalent. • Minimum of 4 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields. • Experience with clinical EDC systems. • Familiarity with the organization and structure of the Trial Master File (TMF). • Familiarity with bio sample management, sample processing, and biobanking best practices. • Competency in SOPs, ICH-GCP, FDA Regulations. • Proficiency in MS Word, Excel and PowerPoint. • Demonstrated ability to work independently and lead projects. • Demonstrated analytical skills and ability to identify complicated problems and propose solutions. • Strong interpersonal skills and communication skills (both written and oral). • Excellent writing skills. • Detail oriented, with solid organization and time management skills.

🏖️ Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. • Free testing for Natera employees and their immediate families. • Fertility care benefits. • Pregnancy and baby bonding leave. • 401k benefits. • Commuter benefits. • Employee referral program.