Clinical Study Associate II

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 Study Associate II (CSA II) at AtriCure 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.

Key Responsibilities:

Study Management:

• 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.

File Management:

• 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.

Monitoring Visits:

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

Reports & Tracking:

• 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.

Finance & Site Payments:

• 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

Communication & Coordination:

• 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.

Other Duties:

• 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.

Leadership & Development:

• 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.

Qualifications and Experience:

• Bachelor's degree preferred, with 1-3 years of relevant experience in clinical research, preferably within medical devices or pharmaceuticals.
• Strong organizational skills with attention to detail and a proactive approach to problem-solving.
• Proficiency in Microsoft Office Suite and experience with clinical databases is advantageous.
• Demonstrated ability to work independently while maintaining effective communication with team members.
• Willingness to travel up to 10% of the time.

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AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits. AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).