Clinical Research Associate II

Atricure, Inc. • Mason, OH • 10h ago

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 II (CRA II) at AtriCure is a critical role within the Clinical Affairs department, responsible for site management and/or monitoring activities during clinical trial execution. This position involves working under moderate supervision to ensure compliance with study protocols and regulatory standards. The CRA II plays a pivotal role in maintaining the integrity of clinical data while adapting to the dynamic needs of different studies.
Key Responsibilities:
Site Management:
Coordinate the collection and review of essential documents from clinical investigation sites in collaboration with study team personnel.
Support site Qualification, Initiation, Interim and Close-Out training visits.
Assist with scheduling of required training sessions (e.g., EDC, Protocol, Device) and support site nomination and qualification processes.
Site Communications:
Serve as the main point of contact for site communications and inquiries.
Liaise with clinical study management, clinical development, site personnel, and CROs, escalating protocol or study related issues as necessary.
Compliance:
Ensure clinical study sites adhere to 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:
Assist in the development of study-related materials, including patient recruitment materials and newsletters.
Facilitate ordering of clinical study devices, including verification and tracking of the devices to ensure proper receipt and storage at study sites
Coordinate activities with study-specific committees, vendor services, and core labs.
Other Duties:
Ensure appropriate translations for study documents.
Contribute to process improvement initiatives and department activities.
Leadership & Development:
Focus on self-development with opportunities to mentor entry-level professionals.
Engage in continuous learning and professional development in clinical research areas.
Qualifications and Experience:
Bachelor's degree with a minimum of 2 years of clinical rese

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