Senior Clinical Research Associate -Lead

Location: Cincinnati, OH
Department: Clinical Affairs
Employment Duration: Full Time Regular
FLSA Status: Exempt
Job Code: 2019-92
Office based or Remote: Office Based

Description

AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (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 and only medical device to receive FDA approval for the treatment of long standing persistent Afib and we have treated over 200,000 patients over the past ten years. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, with more than 130,000 implanted to date. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

 

* This position is an office-based position and not able to be remote.

 

POSITION SUMMARY:

This position will be a key contributor to AtriCure’s clinical affairs department and primarily responsible for the hands-on management of CRAs and the monitoring of clinical study sites. The Sr. CRA will assist in the development, implementation and execution of study protocols and associated study documents for clinical trials and marketing studies, with primary emphasis on monitoring oversight of IDE clinical trials, including development of monitoring plans and review of all monitoring reports. The Sr. CRA will assist in the clinical monitoring of all AtriCure studies, including the coordination of site activities from site start-up to site closure as needed. The Sr. CRA will work closely with the Clinical Project Managers to ensure the study is executed to meet project deliverables.

 

The Sr. CRA will contribute to the protocol design, informed consent development, CRF design, participate in EDC development and testing, preparation of site-specific logs/documentation and investigator study files. Participate in study design review meetings and attend scientific meetings and industry conference as required. The Sr. CRA will conduct clinical site monitoring visits as needed.

 

ESSENTIAL FUNCTIONS OF THE POSITION:

  • Assist Clinical Project Managers in project coordination, planning and logistics, including overview of budget and timelines
  • Present information at investigator meetings as needed
  • Provide daily oversight of all CRAs
  • Develop clinical monitoring plans and assist in development of associated study documents (Safety Monitoring Plans, Data Management Plans, and Informed Consents)
  • Assist CRAs in identification of site issues/problems, and associated root causes, and development action plans to ensure resolution, including escalation of appropriate issues in a timely manner
  • Act as the main line of communication between the sponsor and the CRA
  • Review and approval of monitoring reports and follow up letters
  • Conduct weekly maintenance and management of study sites to ensure site compliance with study protocols, GGP/ICH, and applicable regulations
  • Verify that all research staff and facilities have adequate qualifications and resources and are maintained throughout the course of the clinical study
  • Verify that the investigator and research staff follows the approved protocol and all GCP procedures
  • Ensure adverse events, concomitant medications, and inter-current illnesses are reported in accordance with the protocol on the CRF
  • Communicate deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensure corrective action is implemented
  • Review queries and assist in the resolution of DCFs
  • Participate in project team meetings
  • Participate in departmental development initiatives (e.g. training, SOP development/updates, etc.)

                                                                                                                                  

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

  • Regular and predictable worksite attendance
  • 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 field including 4 plus years as an on-site CRA (including pre-study, initiation, interim monitoring and closeout visits)
  • Lead or Sr. CRA for clinical trial along with management experience of a team of CRAs on project
  • Comprehensive knowledge of ISO, GCP, ICH, FDA and other applicable regulations governing the conduct of clinical trials
  • Ability to manage role/responsibility independently
  • Recognize problems, trends and react to resolve issue quickly and to bring effect resolution
  • Strong attention to detail and an ability to prioritize and juggle multiple/competing issues
  • Experience in resource management
  • Ability to create and manage key internal and external partnerships
  • Excellent written and verbal communication skills
  • Ability to travel 25%

 

PREFERRED QUALIFICATIONS:

  • Experience with medical device and/or complex clinical trials desired but not required
  • Prior experience with cardiovascular clinical trials
  • Understanding of basic anatomy and physiology, electrophysiology and arrhythmias
  • Project Management experience
  • CCRA or CCRP certification

 

OTHER REQUIREMENTS:

  • Ability to regularly walk, sit, or stand as required
  • Ability to occasionally bend and push/pull
  • Ability to regularly lift up to 25 pounds, occasionally lift up to 25 pounds
  • Ability to pass pre-employment drug screen and background check

AtriCure is an Equal Employment Opportunity/Affirmative Action employer. 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).

 

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 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, 15 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




Agency and Third Party Recruiter Notice:

 

Agencies that submit a resume to AtriCure must have a current Agreement in place, executed by a member of the Human Resource/Recruiting Department. In addition agencies may only submit candidates to positions for which they have been invited to do so by one of our Recruiters or Recruiting Managers. All unsolicited resumes sent to us will be considered property of AtriCure and AtriCure will not be held liable to pay a placement fee.


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