Senior Clinical Research Associate

PROCEPT BioRobotics Logo

PROCEPT BioRobotics

πŸ’΅ $102k-$140k
πŸ“Remote - United States

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 ensure compliance with regulations and best practices, collaborating with cross-functional teams. Responsibilities include leading study management, site management, monitoring, regulatory compliance, data management, risk management, and continuous improvement. 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 deep understanding of relevant regulations and guidelines. Preferred qualifications include CRP or SoCRA certification and global research experience. The position offers a competitive salary, annual bonus, equity/RSUs, and a comprehensive benefits package.

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
  • Domestic and international travel would be required for site training, monitoring responsibilities, and educational seminars. Ability to travel up to 70%

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

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