Senior Clinical Research Associate

2 days ago

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PROCEPT BioRobotics

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Surgical Robotics

201 - 500

Description

• Company Overview • Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. • We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. • As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. • That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities. • The Opportunity That Awaits You: • 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

• 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 • Many more!