Clinical Research Associate

Description

Clinical Research Associate

We are seeking a Clinical Research Associate to join our growing team. Reporting directly to the Clinical Manager, you will be responsible for organizing and overseeing clinical studies or trial to contribute to advances in EBR’s product commercialization. Duties also include monitoring data, writing reports, and maintaining sites to determine the overall success of a new medical device. This is an exciting time to join our fabulous team.

This is a hybrid position in Sunnyvale, CA. The typical week will require 3 days/week onsite, or more during peak times. Local candidates are preferred.

Summary of what you will do:

• Ensure that the clinical trial is conducted in compliance with the regulatory requirements of the country or region where the trial is being conducted.
• Ensure that the rights, safety, and well-being of the research subjects are protected throughout the trial and that the data collected during the trial is accurate, complete, and verifiable, including regulatory forms, medication records, case reports, and consent forms.
• Maintain an awareness that the trial is to be conducted within the specified budget.
• Develop relationships with research coordinators and Principal Investigators and supervise study sites and activities to ensure adherence to appropriate industry protocols and terms of the study.
• Prepare final reports, such as monitoring reports, ICFs, draft protocol revisions.
• Review case report issues and clarify or answer data queries as appropriate.
• Assess study operations and identify issues and risks that need action or elevation to senior staff.
• Identify, evaluate, and properly capture Adverse Events (AEs); ensure adequate follow-up, timely documentation and reporting according to internal procedures and regulatory requirements.

Requirements

Education & Experience:

• Bachelor’s Degree preferred or equivalent combination of education and professional experience is acceptable.
• Three or more years of experience in the medical device preferred, or pharmaceutical or biotechnology industries.
• Three or more years of experience in a CRA role working on complex IDE studies. 
• Two or more years of experience preferred having responsibility for the conduct of clinical CROs associated with study (e.g., CRAs, core labs, data management, etc.)

Qualifications:

• Strong expertise in clinical trial management (medical device preferred) and the CRA role and responsibilities.
• Knowledge of regulatory standards (ICH, GCDMP, 21 CFR 11, GDPR)
• Experience with web-based EDC, software tools (Microsoft Office Suite), Adobe,
• SharePoint, shared drive, and other custom web-based software used for administrative functions.
• Ability to assess study operations and identify issues and risks that need action or elevation to senior staff.
• Ability to travel up to 25% of the time, as necessary.

Salary Range:

$95,000 - $135,000

Base pay is one part of your total compensation. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, and alignment with market data. 

EBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please refrain from solicitations at this time.

About EBR Systems

Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company’s patented proprietary Wireless Stimulation Endocardially (WiSETM) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management. 

We are a team of dedicated individuals, driven to deliver superior treatment to millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation. 

As a fast-paced company, every team member at EBR makes important contributions toward our mission. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring a ground-breaking technology to market.

EBR Systems offers a great place to work as well as generous benefits and growth opportunities:

• Medical, dental, vision
• Life, Long-term disability, and AD&D insurance
• 401K
• PTO – starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Weekly company lunches and quarterly happy hour events
• Meaningful work where you can make a difference.