Senior Clinical Research Associate

Job not on LinkedIn

August 3

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Logo of PROCEPT BioRobotics

PROCEPT BioRobotics

Healthcare Insurance • Medical Device • Artificial Intelligence

PROCEPT BioRobotics is a medical technology company specializing in minimally invasive surgical solutions for urological conditions, focusing on Benign Prostatic Hyperplasia (BPH) treatment. The company has developed the Aquablation therapy, which uses a computer-assisted, ultrasound-guided robotic system to deliver precise and personalized treatment without compromising sexual function and continence. Their technology platform is powered by robotics and artificial intelligence to maximize tissue resection while preserving important anatomy. PROCEPT BioRobotics is committed to advancing men's health with proven, precise, and predictable treatments.

📋 Description

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

🎯 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

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