Job Information
Atricure, Inc. Clinical Study Associate II in Cincinnati, Ohio
Clinical Study Associate II Cincinnati, OH, USA * Mason, OH, USA * Minneapolis, MN, USA * Minnetonka, MN, USA Req #2020 Monday, April 8, 2024 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: This position will be a key contributor to AtriCure's clinical affairs department to assist in the development, implementation, and execution of multiple key study functions. The Clinical Study Associate primary responsibilities include but are not limited to supporting device supply logistics, financial processes (contracts, budgets, and invoices), essential document and trial master file (TMF) management and select monitoring activities. The Clinical Associate is a key contributor to AtriCure' s clinical affairs department to assist in the development, implementation, and execution of departmental needs and key study functions. In addition, this position will provide administrative support as needed. The position requires a skilled, professional person who can work well in a matrix team environment and readily adapt as departmental and study needs change over time. Independent judgment is required to plan, prioritize and organize a diversified workload with support/direction from management. Team collaboration and willingness to take on and learn new tasks will also be a key asset critical to success. ESSENTIAL FUNCTIONS OF THE POSITION: Responsible for set-up of the electronic trial master file (eTMF), assists in collection and quality control of documents, files clinical trial documents, and assists in maintenance and ongoing tracking of clinical documents Leads and supports clinical team as needed in identification, creation, documentation, and maintenance of processes required for conduct of a clinical trial Responsible for tracking study activity in collaboration with the clinical team, such as start-up process by ensuring receipt of proper documentation, agreements, and site approvals Responsible for developing, coordinating, managing device processes and logistics from demand planning, device setup in the clinical database, ordering, re-supply and tracking for study sites including quality control and filing of documents Facilitates execution of study contracts and budgets (help as needed to move contracts and agreements through the signature process, limited quality control reviews, record keeping associated with executed contracts) Collaborates with Clinical Project Manager and Clinical Operations Associate to track accruals, processing and reconciliation of payments Responsible for working with Clinical Research Associates (CRAs) in performing monitoring preparation activities and potentially assist in select monitoring activities at local investigational si