Senior Clinical Research Associate

$96,000 - $120,000/Yr

Procept Biorobotics - Remote, OR

Full-time - Senior

Remote, OR

Miscellaneous Manufacturing

About the position

The Senior Clinical Research Associate (Sr. CRA) at PROCEPT BioRobotics plays a vital role in managing, monitoring, and executing clinical trials for innovative surgical robotics aimed at treating benign prostatic hyperplasia (BPH). This position ensures compliance with regulatory requirements and company SOPs while collaborating with cross-functional teams to achieve successful clinical study outcomes. The Sr. CRA is responsible for all aspects of clinical trial management, from site selection to study close-out, and serves as a key point of contact for clinical sites.

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 informed consent forms and study contracts.
• Manage study contract and budget negotiations with assigned sites.
• Serve as a point of contact for clinical sites, addressing questions or concerns related to study conduct.
• Provide training and guidance to junior CRAs, site staff, and investigators on study protocols and regulatory requirements.
• Conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulations.
• Monitor patient enrollment, data collection, and adherence to study protocols.
• Identify, document, and resolve issues related to site performance, including deviations and safety concerns.
• Ensure all clinical trial activities comply with FDA regulations and ISO standards.
• Assist in the preparation of regulatory submissions, including IDEs and PMAs.
• Oversee data collection and ensure data integrity and quality across clinical sites.
• Identify potential risks to study timelines and develop mitigation strategies.
• Participate in the development and review of SOPs to enhance clinical trial efficiency.

Requirements

• Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
• Minimum of 5 years of experience in Medical Device research, with at least 3 years in monitoring.
• In-depth understanding of FDA regulations, EU MDR, ICH GCP guidelines, and ISO 14155.
• Strong organizational, communication, and problem-solving skills.
• Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, Microsoft Office Suite, and Adobe.

Nice-to-haves

• CRP or SoCRA certification preferred.
• Global research experience preferred.

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