AtriCure, Inc. · 2 hours ago
Senior Clinical Research Associate
Minnetonka, MN
Full-time
Onsite
Senior Level
5+ years expAtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. The Senior Clinical Research Associate plays a vital role in managing and overseeing site management and monitoring activities during clinical trial execution, ensuring compliance with regulatory standards and maintaining the integrity of clinical data.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
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
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
Ensure clinical study sites adhere to assigned protocols and regulatory standards, independently reviewing individual site compliance and addressing issues with study 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
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
Manage the processing of product complaints and adverse events, collaborating with safety specialists to gather materials for CEC meetings
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
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
Provide mentorship and guidance to junior team members, fostering a collaborative environment
Engage in continuous professional development and contribute to strategic project management activities
Qualification
Required
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
Benefits
Medical & Dental beginning day 1 of employment
401K plus match
20 days of paid Parental Leave
Maternity leave, for new moms and dads
Volunteer Time off
Pet Insurance
Full access to our on-site fitness center and cafeteria
Company
AtriCure, Inc.
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$201MKey Investors
U.S. Venture Partners
2020-05-12Post Ipo Equity· $175M
2005-08-05IPO
2002-06-10Series Unknown· $21M
Leadership Team
Michael H. Carrel
President and Chief Executive Officer
Tamer Ibrahim
Vice President, Research & Technology
Recent News
Company data provided by crunchbase