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AtriCure, Inc. · 6 hours ago

Clinical Research Associate II

Minnetonka, MN

Full-time

Hybrid

Entry, Mid Level

2+ years exp

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. The Clinical Research Associate II (CRA II) is responsible for site management and monitoring activities during clinical trial execution, ensuring compliance with study protocols and regulatory standards while maintaining the integrity of clinical data.

BiotechnologyHealth CareMedicalMedical Device

Growth Opportunities

Responsibilities

Coordinate the collection and review of essential documents from clinical investigation sites in collaboration with study team personnel

Support site Qualification, Initiation, Interim and Close-Out training visits

Assist with scheduling of required training sessions (e.g., EDC, Protocol, Device) and support site nomination and qualification processes

Serve as the main point of contact for site communications and inquiries

Liaise with clinical study management, clinical development, site personnel, and CROs, escalating protocol or study related issues as necessary

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

Review and analyze data for accuracy and completeness

Manage the creation, resolution, and tracking of data queries

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

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

Assist in the development of study-related materials, including patient recruitment materials and newsletters

Facilitate ordering of clinical study devices, including verification and tracking of the devices to ensure proper receipt and storage at study sites

Coordinate activities with study-specific committees, vendor services, and core labs

Ensure appropriate translations for study documents

Contribute to process improvement initiatives and department activities

Focus on self-development with opportunities to mentor entry-level professionals

Engage in continuous learning and professional development in clinical research areas

Qualification

Clinical research experienceSite managementData managementMicrosoft Office SuiteClinical data management systemsOrganizational skillsCommunication skillsTeamwork