Clinical Research Associate II

Atri Cure, Inc. provides innovative technologies for the treatment of atrial fibrillation and related conditions. Atri Cure’s products include the Isolator® Synergy™ Ablation System, the Atri Clip® Left Atrial Appendage Exclusion System, and the cryoICE cryoSPHERE® probe.

We foster an inclusive culture and offer programs and resources that provide equitable opportunities for every person to contribute professionally and personally.

The Clinical Research Associate II (CRA II) is a key contributor to Atri Cure’s clinical affairs department. The CRA II will manage site operations for assigned clinical investigative sites, assist with the implementation and execution of study protocols, and coordinate site activities from start‑up to close‑out.

• Assist Clinical Project Managers and Sr. CRAs in study development and start‑up, including informed consent forms and internal review prior to IRB/EC submission; collect start‑up documentation from clinical sites.
• Verify that investigators and research staff follow approved protocols and all GCP procedures.
• Conduct weekly maintenance and management of study sites to ensure compliance with study protocol, GCP/ICH, and applicable regulations.
• Conduct initial and ongoing training of site personnel throughout the clinical study.
• Monitor and report site enrollment activities.
• Verify that all research staff and facilities are properly resourced and qualified throughout the study.
• Assist with the preparation of clinical study devices and verify accountability of investigational devices at the study site.
• Ensure adverse events, concomitant medications, and inter‑current illnesses are reported in accordance with protocol on the CRF.
• Communicate deviations from the protocol, SOPs, GCP, and regulatory requirements to investigators and ensure corrective action.
• Review queries and assist in the resolution of DCFs.
• Participate in project team meetings.
• Work on multiple projects as departmental priorities change.

• Maintain regular and predictable work performance.
• Work under fast‑paced conditions.
• Make decisions and use good judgement.
• Prioritise duties and multitask as required.
• Work collaboratively with others.
• Perform additional duties as assigned.

• Bachelor’s degree in a science or related technical field or equivalent combination of education, training and experience.
• Minimum two years of CRA experience.
• Comprehensive knowledge of ISO, GCP, ICH, FDA and other applicable regulations governing clinical trials.
• Ability to manage responsibilities independently.
• Ability to recognize problems, trends and resolve issues quickly.
• Experience with electronic data capture systems.
• Strong attention to detail and ability to prioritise multiple/competing issues.
• Ability to create and manage key internal and external partnerships.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Ability to travel up to 50%.

• Experience with medical device clinical trials (desired but not required).
• Prior experience with cardiovascular clinical trials.
• Understanding of basic anatomy, physiology, electrophysiology and arrhythmias.
• Registered Nurse with prior CRA or Study Coordinator experience.
• CCRA or CCRP certification.

• Ability to regularly walk, sit, or stand as needed.
• Ability to occasionally bend and push/pull as needed.
• Pass pre‑employment drug screen and background check.

Positions located in Minnesota.

Salary: $85,000 – $104,000 USD.

Atri Cure offers benefits for U.S. based employees and families, including medical and dental coverage beginning day one, 401(k) with company match, 30 days of paid parental leave, volunteer time off, pet insurance, and access to an on‑site fitness center and cafeteria. For a complete list, please visit the careers website.

Atri Cure participates in the federal E‑Verify program to confirm the identity of and employment authorization of all newly hired employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law.

Atri Cure is an equal employment opportunity/affirmative action employer and provides a drug‑free workplace.