Clinical Research Associate II

AtriCure•Mason, OH

1d•Hybrid

About The Position

The Clinical Research Associate II (CRA II) at AtriCure is a critical role within the Clinical Affairs department, responsible for site management and/or monitoring activities during clinical trial execution. This position involves working under moderate supervision to ensure compliance with study protocols and regulatory standards. The CRA II plays a pivotal role in maintaining the integrity of clinical data while adapting to the dynamic needs of different studies.

Requirements

Bachelor’s degree
Minimum of 2 years of clinical research experience
Strong organizational and communication skills
Ability to work effectively in a team
Proficiency in Microsoft Office Suite
Familiarity with clinical data management systems
Willingness to travel between 10-75% of the time

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.