AtriCure
Senior Clinical Research Associate
Mason, OH; Minnetonka, MN · Senior · Contract
Sponsorship not specifiedDetected 5 hours ago
Project ManagementOperations ManagementProcess ImprovementClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesResearchLeadershipCommunicationCollaborationMentoring
About the role
- The Senior Clinical Research Associate (Sr.
- CRA) at AtriCure plays a vital role in the Clinical Affairs department, independently managing and overseeing site management and/or monitoring activities during clinical trial execution.
- This position requires a high level of autonomy and leadership, providing guidance to junior team members and ensuring compliance with regulatory standards and protocols.
Responsibilities
- Support development of data cleaning reports and metrics in collaboration with data and operations management teams.
- Manage the processing of product complaints and adverse events, collaborating with safety specialists to gather materials for CEC meetings.
- Support the coordination of activities with study-specific committees, vendor services, and core labs.
Requirements
- Facilitate required training sessions (e.g., EDC, Protocol, Device) and support site nomination and qualification processes.
Skills
- AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions.
- Afib affects more than 33 million people worldwide.
- 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.
- For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
- Draft study-related materials, such as patient brochures and recruitment tools.
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