Senior Clinical Research Associate-Nebraska, CO, Kansas, Utah, Texas, Iowa, N/S Dakota

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

The Opportunity That Awaits You

The Senior Clinical Research Associate (Sr. CRA) plays a critical role in the management, monitoring, and execution of clinical trials. This position is responsible for ensuring that clinical trials are conducted in compliance with regulatory requirements, company SOPs, and industry best practices. The Sr. CRA will work closely with cross-functional teams, including regulatory, quality, and product development, to ensure the successful execution of clinical studies. This role reports into the Senior Director of Clinical Affairs.

What Your Day-to-Day Will Involve

Study Management

• 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.

Site Management

• 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.

Site Monitoring

• 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.

Regulatory Compliance

• 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.

Data Management and Quality Assurance

• 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.

Risk Management

• 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.

Continuous Improvement

• 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.

The Qualifications We Need You to Possess

• Bachelor’s degree in life sciences, nursing, or a related field.
• Advanced degree preferred, or equivalent combination of education and experience.
• Minimum of 5 years of experience in Medical