Senior Clinical Research Associate

Summary

The job is for a Senior Clinical Research Associate at PROCEPT BioRobotics, responsible for managing and monitoring clinical trials, ensuring compliance with regulations, and working with cross-functional teams. The role requires a Bachelor's degree in life sciences or related field, 5 years of experience in Medical Device research, and 3 years in monitoring. Preferred qualifications include ACRP or SoCRA certification, global research experience, and ability to travel up to 70%. The company offers competitive salary, annual bonus, equity/RSUs, and a comprehensive benefits package.

Responsibilities

• Lead and manage all aspects of assigned clinical trials
• 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
• Develop country and site-specific documents
• Manage the study contract and budget negotiation with assigned sites in assigned clinical trials
• Serve as a point of contact for clinical sites, addressing any questions or concerns related to study conduct
• Conduct site qualification, initiation, monitoring, and close-out visits
• Monitor patient enrollment, data collection, and ensure adherence to study protocols
• Identify, document, and resolve any issues related to site performance
• Ensure that all clinical trial activities are conducted in accordance with FDA regulations, ISO standards, and other relevant regional regulations and guidelines
• Assist in the preparation of regulatory submissions
• Oversee data collection and ensure data integrity and quality across clinical sites
• Collaborate with data management teams to review and clean data, ensuring timely data entry and query resolution
• Identify potential risks to study timelines, quality, and patient safety, and develop mitigation strategies
• Monitor adverse events (AEs) and serious adverse events (SAEs) to ensure timely reporting and resolution
• Participate in the development and review of SOPs and work instructions
• Stay current with industry trends, regulatory changes, and advancements in clinical research methodologies