Clinical Research Associate I Mason HQ, 7555 Innovation Way, Mason, Ohio, United States of America * Minnetonka, 130 Cheshire Lane, Minnetonka, Minnesota, United States of America Req #2331 Wednesday, January 15, 2025 AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally. POSITION SUMMARY: The Clinical Research Associate I (CRA I) at AtriCure is a critical entry-level role within the Clinical Affairs department. This position is primarily responsible for managing site communications and/or monitoring activities during clinical trial execution. Under direct supervision, the CRA I ensures compliance with study protocols and regulatory standards, maintaining the integrity and accuracy of clinical data. ESSENTIAL FUNCTIONS OF THE POSITION: Site Management: Coordinate the collection and review of essential documents from clinical investigation sites in collaboration with study team personnel. Schedule and manage required training sessions (e.g., EDC, Protocol) for study sites. Site Communication: Serve as the main point of contact for site communications and inquiries. Act as a liaison between clinical study management, clinical development, site personnel, and CROs, escalating protocol-related issues as needed. Compliance: Ensure clinical study sites adhere to the assigned study protocols and regulatory standards, notifying study management of any concerns. Data Management: Review and analyze data for accuracy and completeness. Manage the creation, resolution, and tracking of data queries. Monitoring: Conduct site monitoring visits (qualification, initiation, interim, and close-out) to ensure adherence to study procedures and regulatory requirements. Safety: Process product complaints and adverse events as reported, collaborating with safety specialists to gather necessary materials for CEC meetings. Study Management: Support the development of study-related materials and assist in the coordination of site contracts and budgets. Support ordering of clinical study devices, including verification and tracking of the devices to ensure proper receipt and storage at study sites Other Duties: Ensure appropriate translations for study documents. Contribute to process improvement initiatives and department activities. Collaborate with clinical study coordinators to ensure site and patient reimbursements. Leadership & Development: Focus on self-development with opportunities to mentor entry-level professionals. Engage in continuous learning and professional development in clinical research areas. ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSI