Senior Clinical Research Associate

Yesterday

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PROCEPT BioRobotics

WebsiteLinkedInAll Job Openings

Surgical Robotics

201 - 500 employees

Founded 2014

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

Description

• The Senior Clinical Research Associate (Sr. CRA) plays a critical role in the management, monitoring, and execution of clinical trials. • Responsible for ensuring that clinical trials are conducted in compliance with regulatory requirements, company SOPs, and industry best practices. • Work closely with cross-functional teams, including regulatory, quality, and product development, to ensure the successful execution of clinical studies.

Requirements

• Bachelor’s degree in life sciences, nursing, or a related field. Advanced degree preferred, or equivalent combination of education and experience • Minimum of 5 years of experience in Medical Device research, with at least 3 years experience in monitoring. BPH or prostate cancer research experienced is preferred. • In-depth understanding of FDA regulations, EU MDR, ICH GCP guidelines, ISO 14155, and medical device clinical research requirements. • Strong organizational, communication, and problem-solving skills. Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, Microsoft Office Suite, and Adobe.

Benefits

• Comprehensive benefits package including full medical coverage • Wellness programs • On-site gym • 401(k) plan with employer match • Short-term and long-term disability coverage • Basic life insurance • Wellbeing benefits • Flexible or paid time off • Paid parental leave • Paid holidays