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Clinical Research Associate II - Registry Studies

AtriCure

AtriCure

Cincinnati, OH, USA · Mason, OH, USA · Minneapolis, MN, USA · Minnetonka, MN, USA
Posted on Tuesday, September 12, 2023

Clinical Research Associate II - Registry Studies

Cincinnati, OH, USA ● Mason, OH, USA ● Minneapolis, MN, USA ● Minnetonka, MN, USA Req #1680
Monday, September 11, 2023
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 Clinical Research Associate II – Registry Studies, will be a key contributor in supporting real-world initiatives at AtriCure. This position will be responsible for site management, and data monitoring of assigned registry projects undertaken in support of the Global Registry portfolio.As a member of the Scientific Affairs team, the role will report to the Manager, Global Registries, and collaborate closely with vendors, site research staff, Clinical Operations, and Data Management teams at AtriCure.


ESSENTIAL FUNCTIONS OF THE POSITION:

  • Serves as the primary point of contact for assigned registry study sites; collaborate with participating registry sites and field team to execute on timely site activations, subject enrollment goals; manage site communications and study-related activities; accountable for data integrity, patient protections, and regulatory compliance for assigned sites.
  • Responsible for set-up and maintenance of the site electronic trial master file (eTMF); tracks, collects and files essential documents,
  • Assists in the preparation and coordination of site contract and budget process, including cross-functional collaboration with AtriCure’s legal team.
  • Conduct site monitoring (qualification, initiation, interim monitoring and close out visits) in accordance with registry SOPs, registry monitoring plan and associated critical variable monitoring plans, to ensure site is adhering to protocol and case completion guidelines, is implementing corrective actions as necessary, and is adhering to applicable regulations and GCP.
  • Assists Registry Manager and Registry Specialists in the development of essential study documentation required for site initiation.
  • Verify that all research staff and facilities have adequate resources and qualifications and are maintained throughout the course of the study
  • Contribute to company’s registry operating procedures.
  • Ability to write clear, succinct, and detailed clinical study monitoring and study visit reports.
  • Maintains open, positive, and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors to successfully achieve all organizational objectives and milestones.
  • Participates in cross-functional project team meetings.
  • Contributes to department initiatives and process improvement as applicable.


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 judgment
  • Ability to prioritize various duties and multitask as required
  • Ability to successfully work with others
  • Additional duties as assigned


BASIC QUALIFICATIONS:

  • Bachelor’s degree in a science or related technical fieldrequired or demonstrated equivalent combination of education, training and experience
  • Minimum two years clinical research experience in a cardiology research environment, medical device trial experience required
  • Comprehensive knowledge of ISO, GCP, ICH, FDA and other applicable regulations governing the conduct of clinical trials
  • Knowledge and experience in clinical trial monitoring and auditing
  • Ability to manage role/responsibility independently.
  • Excellent planning, analytical, and problem-solving skills.
  • Experience working with electronic data capture systems
  • Strong attention to detail and an ability to prioritize and juggle multiple/competing issues.
  • Ability to create and manage key internal and external partnerships.
  • Excellent written and verbal communication skills.
  • Proficiency with Microsoft Office, electronic data capture and other computer data acquisition, data analysis, graphing and plotting results and report writing.
  • Ability to travel 15% as required.
  • Abilities to work with cross-functional teams


PREFERRED QUALIFICATIONS:

  • Previous medical device industry experience
  • CCRA or CCRP Certification
  • Experience with Observational Research


OTHER REQUIREMENTS:

  • Ability to regularly walk, sit, or stand as needed
  • Ability to occasionally bend and push/pull as needed
  • Ability to pass pre-employment drug screen and background check

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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, 20 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: https://www.atricure.com/benefits 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 https://www.e-verify.gov/ 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).

Other details

  • Job Family Clinical Development
  • Job Function Clinical
  • Pay Type Salary
  • Employment Indicator Non Manager
Other details