PROCEPT BioRobotics · 5 months ago
Senior Clinical Research Associate - Nebraska, CO, Kansas, Utah, Texas, Iowa, N/S Dakota
United States
Full-time
Remote
Senior Level
$102K/yr - $140K/yr
5+ years expPROCEPT BioRobotics is committed to revolutionizing treatment for benign prostatic hyperplasia through innovation in surgical robotics. The Senior Clinical Research Associate plays a critical role in managing and executing clinical trials, ensuring compliance with regulatory requirements and collaborating with cross-functional teams to achieve study objectives.
Health CareManufacturingMedical DeviceRobotics
No H1B
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
Qualification
Required
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
Preferred
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
Company
PROCEPT BioRobotics
PROCEPT BioRobotics is a surgical robotics company that develops water-based robotic systems for prostate surgery.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$820.34MKey Investors
CIBC Innovation BankingFidelityViking Global Investors
2024-10-29Post Ipo Secondary· $175M
2023-08-01Post Ipo Equity· $150M
2022-10-10Post Ipo Debt· $52M
Leadership Team
Mohan F. Sancheti
Vice President Operations
Recent News
thefly.com
2025-12-09
2025-11-07
PROCEPT BioRobotics
2025-11-05
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