Clinical Study Associate II

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.