Clinical Study Associate II – TMF & Device Trials

AtriCure; Mason (OH); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical & Dental from day 1

401K with match

Parental Leave - 30 days

Volunteer Time Off

On-site fitness center & cafeteria

Job summary

AtriCure is seeking a Clinical Study Associate II to support and coordinate clinical studies within the Clinical Affairs department. The role involves managing TMF setup, regulatory filings, monitoring visit support, and ensuring accurate study documentation.

The CSA II will handle payments, vendor coordination, data integrity, and process improvements while traveling up to 10% as needed. The position requires a Bachelor’s degree preference with 1–3 years in clinical research, strong

Qualifications

• Bachelor’s degree preferred with 1–3 years in clinical research, preferably medical devices or pharma.
• Strong organizational skills and attention to detail are essential.
• Ability to work independently while keeping team members informed.
• Proficiency with Microsoft Office; experience with clinical databases is advantageous.

Responsibilities

• Develop and manage Master TMF setup and study inbox frameworks for trials.
• Maintain TMF filings and ensure site regulatory documents are accurate.
• Support monitoring visits with document reviews and follow-up actions.
• Generate IRB renewal status reports and assist with site credentialing.
• Oversee device shipments, reconciliations, and accountability entries.
• Process site and vendor payments and assist accrual reporting.
• Coordinate study materials and trainings; lead project communications.
• Provide mentorship to junior team members and support process improvements.

Skills

Organizational skills

Problem-solving

MS Office proficiency

Independent worker

Travel readiness

Education

Bachelor’s degree preferred

Tools

Clindex

Job description

AtriCure is seeking a Clinical Study Associate II to support and coordinate clinical studies within the Clinical Affairs department. The role involves managing TMF setup, regulatory filings, monitoring visit support, and ensuring accurate study documentation.

The CSA II will handle payments, vendor coordination, data integrity, and process improvements while traveling up to 10% as needed. The position requires a Bachelor’s degree preference with 1–3 years in clinical research, strong