Clinical Research Associate I

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 100,000 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®, Senza Omnia™, and Senza HFX iQ™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. HFX iQ, Nevro’s latest innovation, is the first and only SCS System that uses Artificial Intelligence to optimize and maintain pain relief using each patient's response 1 .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

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.

• Perform periodic audits of clinical study files for completeness
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
• Ensure compliance with the sponsor's responsibility to provide any new information to the investigator during the course of the study
• Other duties as assigned.
• 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
• Accompany SCRA on site visits to assist with clinical monitoring tasks
• Provide assistance in specific tasks relating to the preparation of the project (e.g. preparation of protocols, ICF, preparation of planning documents, BIMO preparation)
• Assist in the development of any necessary tools to allow studies to proceed expeditiously (e.g. newsletter, payments, IRB, monitoring trackers)
• Create and review reports for investigator compensation payments and reimbursements.
• Assist Senior Clinical Research Associates (SCRA) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
• 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.
• 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
• Help identify and resolve data discrepancies to support data review in a timely manner
• Track study progress using study tracking tools, ensuring timely and quality updates

Role Requirements

• BS in life sciences
• 2 years of related experience in supporting medical device clinical trials

Skills And Knowledge

• High attention to detail and accuracy
• Able to manage multiple tasks
• Strong interpersonal and communication skills
• Demonstrated proficiency with MS Office Suite (Word, Excel and PowerPoint)
• Experience working directly with US and EU sites strongly desired
• Good problem-solving skills
• Experience working with clinical data and databases (desirable)

Target Pay Range

$ 67, 009 to $ 92,137 - the final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, alignment with market data, and geography. *Nevro is a multi-state employer, so the target pay range may increase or decrease depending on the city/state.

Full-time Nevro team members enjoy a full suite of additional benefits such as market-leading medical, dental, and vision benefits, 401k matching, ample vacation time, pre-tax savings perks, tuition reimbursement, Employee Stock Purchase Plan (ESPP), short and/or long-term incentive opportunities, recognition awards, volunteer time off, and several employee resource groups that focus on supporting our Wellness, Leadership Development, and Diversity and Inclusion.”

EEO Statement

Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, protected veteran status, disability, age or other characteristics protected by laws.