Clinical Study Associate II

Atri Cure, 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 Atri Cure technologies for the treatment of Afib and reduction of Afib related complications. Atri Cure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.

Atri Cure’s Atri Clip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. Atri Cure’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  or follow us on Twitter @Atri Cure.

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.

The Clinical Study Associate II (CSA II) at Atri Cure plays a vital role in supporting and coordinating clinical studies within the Clinical Affairs department. This position requires a proactive individual who can manage administrative functions, maintain regulatory compliance, and ensure the orderly execution of clinical studies. The CSA II works under moderate supervision and is pivotal in ensuring the accuracy and integrity of clinical documentation and study data.

• Develop and manage the setup of Master Trial Master Files (TMF) and study inbox frameworks for clinical studies.
• Conduct quality control and audit preparedness of TMF files, identifying and escalating key issues to the clinical study team.

• Maintain accurate filing of site initiation and regulatory documents within the TMF.
• Ensure timely and correct entry of site information into clinical databases such as Clindex.

• Support preparation for monitoring visits, including document reviews and follow-up activities as required by the study.

• Generate and manage IRB renewal status reports, notifying sites or study team of pending renewals.
• Conduct physician credentialing activities in compliance with clinical operation procedures.
• Oversee the organization and tracking of shipments related to study materials and devices.
• Support overall device reconciliation activities, including management of device returns and entry of device accountability into clinical databases.

• Process site and patient payments as per the direction of the clinical study team.
• Manage payment processing for vendors, HCPs, and consultants.
• Support monthly/quarterly clinical accrual reporting to the Clinical Project Manager

• Lead the development and management of clinical trial materials and communications, including study newsletters.
• Coordinate logistics for internal and external meetings and manage the scheduling of training sessions.

• Manage vendor setup requests and clinical purchase order requisitions.
• Support process improvement initiatives related to the CSA function.
• Assist in site qualification activities and adverse event document management.

• The CSA II is expected to provide guidance and mentorship to junior team members as required.
• Opportunities for involvement in process improvement and project management activities or other duties as assigned for development.