Clinical Research Associate

Yesterday

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Natera

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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.

Non-Invasive Prenatal Testing (NIPT) • Single gene diseases • Preimplantation Genetic Screening (PGS)/Diagnosis (PGD) • Biopsy training • Multi-Disease Carrier Screening

1001 - 5000 employees

Founded 2004

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• The Clinical Research Associate helps support execution of clinical research studies, including site management, training, data monitoring, ethics board approval and submission management, and budget and contract review. • Provide logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out. • Develop study-related documents with Clinical Trial Manager guidance including: informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required • Assist with managing study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites • Support the Clinical Data Management team in the design and content of CRFs, completion guidelines, including support and testing of an EDC system • Assist in the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements • Overseeing clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information • Monitor and track clinical trial progress, provide status update reports to Clinical Trial Manager • Train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues • Monitor studies following study monitoring plans to identify protocol deviations or data discrepancies • Perform study activities including consent, ethics board submissions, participant data and sample tracking using in-house and CRO databases, for studies where Natera functions as a Clinical Research Site. • Support prospective sample testing for studies where Natera functions as a central testing facility • Partner with other research and development groups at Natera to achieve deliverables • This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job. • Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, human subjects protection, and GCP. • Must maintain a current status on Natera training requirement including General Policies and Procedure Compliance and security training.

🎯 Requirements

• BA/BS degree in life sciences, related field, or equivalent • Minimum of 2 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields

🏖️ Benefits

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. • Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. • Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. • We also offer a generous employee referral program!