Senior Clinical Research Associate

Summary

Join PROCEPT BioRobotics as a Senior Clinical Research Associate (Sr. CRA) and play a pivotal role in managing and monitoring clinical trials. You will lead all aspects of assigned trials, from site selection to close-out, ensuring compliance with regulations and best practices. Collaborate with cross-functional teams, including regulatory, quality, and product development. Responsibilities include developing study plans, managing site contracts, conducting monitoring visits, overseeing data collection, and ensuring data integrity. The ideal candidate possesses a Bachelor's degree in a life science field, 5+ years of medical device research experience (3+ years in monitoring), and a strong understanding of FDA regulations and GCP guidelines. This role requires domestic and international travel.

Requirements

• Bachelor’s degree in life sciences, nursing, or a related field
• Minimum of 5 years of experience in Medical Device research, with at least 3 years experience in monitoring
• 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
• Work Authorization Status: Citizen / Permanent Resident

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
• Develop country and site-specific documents including but is not limited to the informed consent form, study contract and budget, study flyers, patient brochures, etc
• 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
• Provide training and guidance to junior CRAs, site staff, and investigators on study protocols, GCP, and regulatory requirements
• Maintain effective communication with clinical sites, ensuring they are informed of study updates and timelines
• 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
• Assist in the preparation of regulatory submissions, including IDEs, PMAs, and 510(k)s
• Ensure proper documentation and maintenance of the Trial Master File (TMF) in accordance with regulatory requirements
• 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 to enhance the efficiency and quality of clinical trials
• Stay current with industry trends, regulatory changes, and advancements in clinical research methodologies

Preferred Qualifications

• Advanced degree preferred, or equivalent combination of education and experience
• BPH or prostate cancer research experienced is preferred
• CRP or SoCRA certification preferred
• Global research experience preferred

Benefits

• Full medical coverage
• Wellness programs
• On-site gym
• A 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
• Annual bonus
• Equity/RSUs