Clinical Research Associate

Part-Time | Offsite & In Person as needed at the Petaluma office. QT Imaging is a medical device company engaged in research, development, and commercialization of innovative body imaging systems using low frequency sound waves. QT Imaging strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience. For more information on QT Imaging, please visit the company’s website at Job Description Overview QT Imaging is seeking a motivated and detail-oriented Clinical Research Associate (CRA) to support the execution and management of clinical studies for our medical imaging technologies. Reporting directly to the Director of Clinical Operations, this part-time, remote position will play a key role in ensuring clinical studies are conducted in compliance with applicable regulations, Good Clinical Practice (GCP), study protocols, and company procedures. The ideal candidate is an experienced clinical research professional who thrives in a collaborative, fast-paced environment and is comfortable working independently while coordinating with clinical sites, investigators, contract research organizations (CROs), and internal stakeholders. Key Responsibilities Clinical Study Management Support the planning, initiation, execution, monitoring, and closeout of clinical studies. Assist in development and review of study documents, including protocols, informed consent forms, case report forms, investigator brochures, and monitoring plans. Coordinate study activities with clinical study sites, CROs, and vendors. Track study progress, enrollment metrics, protocol compliance, and study milestones. Support clinical trial master file (TMF) maintenance and study documentation. Site Management and Monitoring Conduct remote and occasional on-site monitoring activities, including site qualification, initiation, interim monitoring, and closeout visits. Review study data for accuracy, completeness, and protocol compliance. Identify, document, and follow up on protocol deviations and site issues. Develop strong working relationships with investigators and site personnel. Assist sites with study-related questions and operational challenges. Regulatory and Quality Compliance Ensure study conduct complies with FDA regulations, ISO 14155, ICH-GCP guidelines, and company procedures. Support preparation and maintenance of essential regulatory documentation. Assist with inspection and audit readiness activities. Contribute to CAPA and quality management activities as needed. Data Review and Reporting Review clinical data and source documentation for completeness and consistency. Assist in generating study status reports, executive study dashboards, and clinical study updates. Support data cleaning, query resolution, and database lock activities. Participate in investigator meetings and internal project review meetings. Cross-Functional Collaboration Work closely with Clinical Affairs, Regulatory Affairs, Quality Assurance, Product Development, and external partners. Support preparation of clinical evidence summaries, regulatory submissions, and conference presentations as needed. Contribute to continuous improvement of clinical processes and procedures. Prior Experience Qualifications & Requirements Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, Public Health, or a related field. Minimum 5 years of clinical research experience, including site monitoring responsibilities and data query resolution. Experience supporting FDA-regulated clinical studiesinvolving medical devices. Experience with diagnostic imaging, radiology, breast imaging, digital health , AI-driven technologies, or women’s health studies. Experience supporting IDE studies and regulatory submissions. Working knowledge of GCP, ICH, FDA regulations, and ISO standards applicable to medical device clinical trials. Experience with electronic data capture (EDC) and clinical trial management systems (CTMS) , and clinical quality systems. Strong project management, analytical, and problem-solving skills. Excellent written and verbal communication skills. Ability to work independently in a remote environment. Proficiency with Microsoft Office applications. Willingness and ability to travel periodically for site visits and study-related meetings. Previous experience in a startup or emerging medical device company. ACRP or SOCRA certification preferred. Additional Skills Clinical site management Attention to detail and documentation excellence Critical thinking and problem-solving Project coordination and prioritization Relationship building and timely communicationOops! } #J-18808-Ljbffr QT Imaging, Inc.