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PROCEPT BioRobotics is seeking a Senior Clinical Research Associate (Sr. CRA) to manage, monitor, and execute clinical trials for their innovative surgical robotics in the treatment of benign prostatic hyperplasia (BPH). The goal is 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.
• Domestic and international travel would be required for site training, monitoring responsibilities, and educational seminars. 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.
• Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
• Understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.