POSITION SUMMARY:

The Senior Clinical Research Associate (Sr. CRA) at AtriCure plays a vital role in the Clinical Affairs department, independently managing and overseeing site management and/or monitoring activities during clinical trial execution. This position requires a high level of autonomy and leadership, providing guidance to junior team members and ensuring compliance with regulatory standards and protocols. The Sr. CRA is instrumental in maintaining the integrity of clinical data and adapting to evolving study needs.

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.
• Conduct Site Qualification, Initiation, Interim and Close-Out training visits.
• Facilitate required training sessions (e.g., EDC, Protocol, Device) and support site nomination and qualification processes.

Site Communications

• Act as the primary point of contact for site communications and inquiries.
• Liaise with clinical study management, field personnel, and CROs, addressing moderately complex protocol or study related issues as necessary.

Compliance

• Ensure clinical study sites adhere to assigned protocols and regulatory standards, independently reviewing individual site compliance and addressing issues with study management.

Data Management

• Review and analyze data for accuracy and completeness.
• Lead the creation, management, and resolution of data queries for assigned sites
• Support development of data cleaning reports and metrics in collaboration with data and operations management teams.

Monitoring

• Conduct site monitoring visits (qualification, initiation, interim, and close-out) to ensure adherence to study procedures and regulatory requirements.
• Assist in reviewing peer interim monitoring visit (IMV) reports.

Safety

• Manage the processing of product complaints and adverse events, collaborating with safety specialists to gather materials for CEC meetings.

Study Management

• Draft study-related materials, such as patient brochures and recruitment tools.
• Support the coordination of activities with study-specific committees, vendor services, and core labs.

Leadership and Development

• Provide mentorship and guidance to junior team members, fostering a collaborative environment.
• Engage in continuous professional development and contribute to strategic project management activities.

Other Duties

• Ensure appropriate translations for study documents and engage in global process improvement initiatives.
• Mentor less experienced clinical team members and participate in core team activities.
• Contribute to departmental SOPs and work instructions, driving revisions as necessary.

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 with a minimum of 5 years of clinical research experience.
• Strong leadership, organizational, and communication skills with the ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite and familiarity with clinical data management systems.
• Willingness to travel between 10-75% of the time.

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed

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