Nevro Corp.

Senior Clinical Research Associate (East Coast)

US-CA-Redwood City, Remote
1 month ago
ID
2017-1824
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

 

  • Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
  • Provides significant hands-on support for clinical trial activities
  • Develops and refine clinical trial procedures, study tools, patient materials, and presentations
  • Creates informed consents, safety plans, monitoring plans, ICD codes reference and protocol training presentations
  • Collaborates with Data Management staff on the design of documents
  • Acts as lead for assigned projects and/or Project Team Meetings
  • Directs and enhances patient recruitment activities
  • Assesses physicians and clinical sites for qualifications and experience
  • Negotiates budget and works with Legal and Compliance departments to negotiate clinical trial agreement language
  • Trains and ensures certification of study site personnel
  • Monitors clinical sites and provides technical assistance, as necessary
  • Ensures site compliance with regulations and study protocol
  • Identifies deviation trends at sites and  non-compliance
  • Creates and oversees corrective action plans for the clinical sites
  • Verifies study data on source documentation and case report forms (CRFs) to ensure compliance with the study protocol, ICH GCPs, and SOPs. Identify and resolve data discrepancies.
  • Manages material logistics for the studies
  • Writes and files Adverse Event reports and annual reports for Institutional Review Boards
  • Reports site progress to management
  • Maintains a high level of professional expertise through familiarity with scientific literature, Company product portfolio, and competitive environments
  • Processes and applies specific knowledge to the completion of difficult work assignments
  • Coordinates the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well

Role Requirements

 

  • BS in life sciences or equivalent with a minimum of 7 years related experience in supporting medical device clinical trials

Skills and Knowledge

 

  • Strong interpersonal and communication skills
  • Able to manage multiple tasks
  • Good problem-solving skills
  • Comfort in small company. Understands the start-up environment
  • Experience working directly with US, including IDE and post-market studies
  • Experience working with clinical data and databases
  • Ability to travel up 50-70%
  • Demonstrated proficiency with MS Office Suite (Word, Excel and PowerPoint)
  • High attention to detail and accuracy

#LI-GR1

 

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