Job description
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.
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.
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
- Other duties as assigned.
Role Requirements:
- 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)
- Demonstrated proficiency with MS Office Suite (Word, Excel and PowerPoint)
- High attention to detail and accuracy
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.”
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