Nevro Corp.

Clinical Research Associate - InHouse

US-CA-Redwood City
1 month ago
ID
2017-1860
Category
Clinical

About Nevro

Nevro is a medical device company headquartered in Redwood City, California. We have developed HF10™ therapy, an innovative, evidence-based neuromodulation platform for the treatment of chronic pain.

We started with a simple mission to help more patients suffering from chronic pain. At each stage of development, our research was subject to the highest levels of scientific rigor, resulting in a new therapy that has advanced the state of spinal cord stimulation (SCS).

The Nevro® Senza® SCS System received CE mark in 2010, TGA approval in 2011, FDA approval in 2015, and is commercially available in Europe, Australia, and the United States.

Overview

Work directly with management and other clinical research personnel to ensure the successful conduct of clinical projects, and to satisfy applicable regulatory standards and Nevro internal requirements for clinical studies.

Role Requirements

  • Assist Senior Clinical Research Associates (SCRA) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
  • Provide assistance in specific tasks relating to the preparation of the project (e.g. preparation of protocols, ICF, preparation of planning documents, BIMO preparation)
  • Act as a central contact for the clinical team for designated project communications,
  • correspondence and associated documentation
  • Track study progress using study tracking tools, ensuring timely and quality updates
  • Manage and maintain Clinical Investigational Study Files to ensure the conduct of the trial is compliant with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements, and SOPs
  • Perform periodic audits of clinical study files for completeness
  • Oversee the organization and distribution of clinical study materials (e.g. site and patient binders, enrollment tools) working with study sites to ensure needs are fulfilled
  • Create and review reports for investigator compensation payments and reimbursements.
  • Assist in the development of any necessary tools to allow studies to proceed expeditiously (e.g. newsletter, payments, IRB, monitoring trackers)
  • Ensure compliance with the sponsor's responsibility to provide any new information to the investigator during the course of the study
  • Accompany SCRA on site visits to assist with clinical monitoring tasks
  • Assist SCRA to verify study data on source documentation and case report forms (CRFs) to ensure compliance with the study protocol, ICH GCPs, and SOPs.  
  • Help identify and resolve data discrepancies to support data review in a timely manner

 

Skills and Knowledge

  • BS in life sciences
  • 2 years of related experience in supporting medical device clinical trials
  • Strong interpersonal and communication skills
  • Able to manage multiple tasks
  • Good problem-solving skills
  • Experience working directly with US and EU sites strongly desired
  • Experience working with clinical data and databases (desirable)

 

 

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