Senior Clinical Research Associate

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 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. 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 US Pay Range

$106,000 - $125,000 USD

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, 30 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: . 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 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). Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in AtriCure’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 07/31/2029 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at . How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury #J-18808-Ljbffr Atricure,-Inc