Clinical Research 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 Research Associate I (CRA I) at AtriCure is a critical entry-level role within the Clinical Affairs department. This position is primarily responsible for managing site communications and/or monitoring activities during clinical trial execution. Under direct supervision, the CRA I ensures compliance with study protocols and regulatory standards, maintaining the integrity and accuracy of clinical data.

ESSENTIAL FUNCTIONS OF THE POSITION:

Site Management:

• Coordinate the collection and review of essential documents from clinical investigation sites in collaboration with study team personnel.
• Schedule and manage required training sessions (e.g., EDC, Protocol) for study sites.

Site Communication:

• Serve as the main point of contact for site communications and inquiries.
• Act as a liaison between clinical study management, clinical development, site personnel, and CROs, escalating protocol-related issues as needed.

Compliance:

• Ensure clinical study sites adhere to the assigned study protocols and regulatory standards, notifying study management of any concerns.

Data Management:

• Review and analyze data for accuracy and completeness.
• Manage the creation, resolution, and tracking of data queries.

Monitoring:

• Conduct site monitoring visits (qualification, initiation, interim, and close-out) to ensure adherence to study procedures and regulatory requirements.

Safety:

• Process product complaints and adverse events as reported, collaborating with safety specialists to gather necessary materials for CEC meetings.

Study Management:

• Support the development of study-related materials and assist in the coordination of site contracts and budgets.
• Support ordering of clinical study devices, including verification and tracking of the devices to ensure proper receipt and storage at study sites

Other Duties:

• Ensure appropriate translations for study documents.
• Contribute to process improvement initiatives and department activities.
• Collaborate with clinical study coordinators to ensure site and patient reimbursements.

Leadership & Development:

• Focus on self-development with opportunities to mentor entry-level professionals.
• Engage in continuous learning and professional development in clinical research areas.

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:

• Bachelor's degree in science or a technical field preferred, with a minimum of 1 year of clinical research experience.
• Previous experience in site management and CRA roles is advantageous.
• Strong organizational and communication skills with an ability to work effectively in a team.
• Proficiency in Microsoft Office Suite and familiarity with clinical data management systems.
• Willingness to travel between 10-50% of the time.

OTHER REQUIREMENTS:

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

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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, 20 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).