[Hiring] Clinical Study Associate I @AtriCure

Role Description

The Clinical Study Associate I (CSA I) at AtriCure is an entry-level position within the Clinical Affairs department. This role is crucial for supporting the execution of clinical studies, ensuring compliance with regulatory requirements, and maintaining the integrity of clinical data. The CSA I will work under direct supervision, providing administrative and operational support to clinical study teams.

Key Responsibilities:

• Study Management:
  • Assist in the setup and development of Trial Master Files (TMF) and maintain site regulatory documents.
  • Support the coordination and execution of site-specific documents.
• File Management:
  • Ensure accurate filing of site initiation and regulatory documents within the TMF.
  • Assist in the entry and management of site information into clinical databases.
• Monitoring Visits:
  • Support preparation for monitoring visits, including internal regulatory file reviews and document preparation.
  • Assist with follow-up actions post-monitoring visits as directed by the Clinical Operations Manager.
• Reports & Tracking:
  • Support the preparation of IRB renewal status reports and notify the study team of upcoming renewals.
  • Support physician credentialing activities as directed by the Clinical Operations Manager.
  • Track and report the shipment and distribution of study-related materials and devices.
• Finance & Site Payments:
  • Assist in processing site and patient payments as instructed by the study team.
  • Support the reconciliation of payment issues and assist in vendor setup requests.
• Communication & Coordination:
  • Facilitate the distribution of study-specific materials and tools.
  • Coordinate internal and external meeting scheduling and logistics.
• Leadership & Development:
  • This role focuses on self-development and gaining foundational knowledge in clinical research.
  • Perform additional duties as assigned for development.

Qualifications

• High School Diploma or Secondary School Degree required; Bachelor's degree in a related field preferred.
• Demonstrated interest in clinical research and regulatory compliance.
• Strong organizational skills and attention to detail.
• Proficiency in Microsoft Office Suite and experience with clinical databases is beneficial.
• Excellent communication skills and ability to work effectively in a team environment.
• Willingness to travel up to 10% of the time.

Benefits

• Medical & Dental beginning day 1 of employment.
• 401K plus match.
• 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads.
• Volunteer Time off.
• Pet Insurance.
• Access to on-site fitness center and cafeteria for corporate-based employees.