Clinical Study Associate I - Part Time Temp

AtriCure•Mason, OH

8d•Remote

About The Position

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. This is a 6-month temporary position.

Requirements

High School Diploma or Secondary School Degree required
Demonstrated interest in clinical research and regulatory compliance.
Strong organizational skills and attention to detail.
Proficiency in Microsoft Office Suite
Excellent communication skills
Ability to work effectively in a team environment.
Willingness to travel up to 10% of the time.

Nice To Haves

Bachelor's degree in a related field preferred.
Experience with clinical databases is beneficial.

Responsibilities

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.
Ensure accurate filing of site initiation and regulatory documents within the TMF.
Assist in the entry and management of site information into clinical databases.
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.
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.
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.
Facilitate the distribution of study-specific materials and tools.
Coordinate internal and external meeting scheduling and logistics.
Perform additional duties as assigned for development.