Clinical Research Associate

A global medical device company in growth mode, specializing in groundbreaking, minimally invasive targeted tumor treatment technologies, specifically focusing on advanced and interventional oncology for breast cancer clinical studies is hiring a Remote Clinical Research Associate to work in the United States. As a Clinical Research Associate (CRA), you will play a key role in advancing investigational medical technology by working closely with physicians, investigators, and clinical research teams. You will help ensure that clinical studies are conducted with the highest standards of quality, scientific rigor, regulatory compliance, and patient safety, while supporting sites throughout study execution. You will be responsible for coordinating clinical study activities, supporting, and monitoring research sites, maintaining high-quality clinical documentation and data, and ensuring compliance with protocols, GCP, and applicable regulations. Working closely with internal teams, you will help drive study progress, resolve issues effectively, and ensure that clinical research is conducted to the highest standards. This is an opportunity to join a growing medical device company, work close to the clinical field, and contribute directly to the development and evaluation of a technology designed to make a difference for patients. What You Will Do Clinical Study Execution & Site Management Coordinate clinical study activities throughout the study lifecycle, from site selection and activation through study close-out. Conduct and/or support site initiation, monitoring, and closeout activities in accordance with the monitoring plan, including review of source documentation, informed consent, investigational device accountability, and protocol compliance, as applicable. Maintain ongoing communication with clinical research sites and investigators, and follow up on study-related issues, queries, and documentation. Monitor site performance and enrollment activities, identify potential risks or barriers, and elevate issues as appropriate to ensure timely study execution. Review patient eligibility, informed consent, and study requirements, as applicable, to support compliance with the protocol and applicable regulatory requirements. Train site staff on protocol requirements, source documentation, and CRF completion, and provide ongoing training and clarification as needed throughout the study. Work collaboratively with the Clinical Operations team, CRO, Data Management, Regulatory, Quality, Safety, and other cross-functional stakeholders to ensure effective study execution, timely resolution of issues, and achievement of study milestones. Clinical Documentation & Data Prepare and maintain essential clinical study documentation in accordance with the protocol, SOPs, and applicable regulatory requirements. Support data collection, cleaning, and resolution of missing or inconsistent data. Maintain the Trial Master File, regulatory site files, and clinical data systems. Ensure study documentation is complete, accurate, and inspection-ready. Prepare and maintain study trackers, monitoring reports, follow-up letters, action-item logs, and other clinical study records. Regulatory, Safety & Quality Ensure clinical studies are conducted in compliance with protocols, SOPs, ICH-GCP, and applicable U.S. regulations. Identify, document, and report adverse events, serious events, device-related issues, and customer complaints, as required. Identify protocol deviations, non-compliance, and quality issues, and ensure appropriate escalation and documentation. Support study readiness for monitoring, audits, and regulatory inspections. Coordinate investigational devices and clinical trial materials, including ordering and tracking. Requirements: Bachelor’s degree in a scientific, clinical, healthcare, or engineering-related field 3+ years of experience as a Clinical Research Associate or in a closely related clinical research role. GCP training and hands‑on clinical research experience Experienced in the medical device industry, including familiarity with medical device terminology and clinical research practices. Experienced working directly with clinical research sites, investigators, and study teams Strong understanding of clinical research processes and documentation Strong verbal and written communication skills Strong teamwork and collaboration skills, with the ability to work effectively with cross‑functional teams and build positive relationships with clinical sites and investigators. Excellent organization, attention to detail, and ability to manage multiple study activities. Proficiency in Microsoft Office, particularly Word, Excel, and PowerPoint Willingness and ability to travel regularly to clinical research sites. Preferred Experienced in oncology or other cancer‑related clinical research. Experienced with investigational medical devices or minimally invasive procedures. Experienced working with other CRAs Familiarity with clinical data systems and electronic study documentation #J-18808-Ljbffr