Clinical Study Associate I
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 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.
ESSENTIAL FUNCTIONS OF THE POSITION:
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.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable work performance
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgement
- Ability to prioritize various duties and multitask as required
- Ability to successfully work with others
- Additional duties as assigned
BASIC 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.
Positions in Minnesota
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, 30 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).
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