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 requirementsMaintain 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 Device research, with at least 3 years experience in monitoring. BPH or prostate cancer research experienced is preferred.
- 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.
The Qualifications We Would Like You to Possess
- 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%.
Understanding PROCEPT's CultureAt PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers. And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances. An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world! BENEFITS OF WORKING AT PROCEPT!PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes 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, and many more!
EQUAL EMPLOYMENT OPPORTUNITY STATEMENTPROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization. PAY RANGE TRANSPARENCYProcept is committed to fair and equitable compensation practices. The pay range(s) for this role is listed below and represents base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above. WORK ENVIRONMENTWe’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.
United States
