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PROCEPT BioRobotics is looking to revolutionize treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics and needs a Senior Clinical Research Associate to manage, monitor, and execute clinical trials to ensure compliance with regulatory requirements and successful execution of clinical studies.

Requirements

• In-depth understanding of FDA regulations, EU MDR, ICH GCP guidelines, ISO 14155, and medical device clinical research requirements.
• Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, Microsoft Office Suite, and Adobe.
• 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.
• CRP or SoCRA certification preferred.
• Global research experience preferred.
• Ability to travel up to 70%.

Responsibilities

• Lead and manage all aspects of assigned clinical trials, from site selection and initiation to study close-out.
• Develop and implement study plans, timelines, and budgets in collaboration with the Clinical Project Manager.
• Coordinate with cross-functional teams to ensure that study objectives are met.
• Conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance with study protocols, GCP, and applicable regulations.
• Monitor patient enrollment, data collection, and ensure adherence to study protocols.
• Identify, document, and resolve any issues related to site performance, including deviations, data discrepancies, and safety concerns.
• Ensure that all clinical trial activities are conducted in accordance with FDA regulations, ISO standards, and other relevant regional regulations and guidelines.

Other

• Bachelor’s degree in life sciences, nursing, or a related field. Advanced degree preferred, or equivalent combination of education and experience
• Strong organizational, communication, and problem-solving skills.
• Domestic and international travel would be required for site training, monitoring responsibilities, and educational seminars.
• Work Authorization Status: Citizen / Permanent Resident
• Eligibility for an annual bonus and equity/RSUs.