Sr. Clinical Research Associate

Job Locations US-CA-Redwood City, Remote
Job Post Information* : Posted Date 3 weeks ago(9/7/2022 4:38 PM)
ID
2022-3832
Category
Clinical & Regulatory

About Nevro

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 80,000 patients globally.

 

Nevro’s comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy.  Senza®, Senza II®, and Senza Omnia™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro’s unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management.

Job Summary & Responsibilities

  • 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

 

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