Clinical Research Associate
At AtriCure, we are dedicated to improving the quality of life by making exceptional surgical devices that provide doctors with alternative methods to perform surgical procedures. Our unique technology allows surgeons to precisely and efficiently ablate tissue during surgical procedures.
Headquartered in the Cincinnati Ohio area, we offer a competitive salary, outstanding benefits package and the professional advantages of an environment that supports your development and recognizes your achievements. We are an Equal Opportunity Employer.
Summary
The Clinical Research Associate will assist in development, implementation & execution of study protocols for clinical trials & marketing studies, with primary emphasis on monitoring of IDE clinical trials. The position will also assist in the clinical monitoring of all AtriCure ongoing studies including the coordination of site activities from site start-up to closure (i.e., site selection, IRB approvals, routine monitoring, data review, management, and regulatory compliance) for applicable studies.
The CRA will organize and conduct clinical site monitoring visits as required. Complete site visit reports, site correspondence, telephone logs, and other relevant documents to include tracking and report screening and enrollment efforts at study sites. Ensure site research staff is informed and complies with protocol, study-related procedures, and GCP. Maintain and archive study administrative files at study site. Ensure investigational devices are properly stored and accounted for and records are maintained. Ensure site is current with IRB and sponsor communications, adverse event reports, protocol deviations and regulatory documents. Ensure laboratory certifications, test equipment calibrations (if applicable) and pertinent normal laboratory values are maintained. Contribute to CRF design, preparation of site specific logs and investigator study files. Participate in design review meetings and attend scientific meetings/industry conferences as required. Position may require 60-80% travel.
Roles and Responsibilities
- Assist with the clinical monitoring of all ongoing study sites.
- Work with sites to ensure timely and accurate data management.
- Assist with data management including querying for the AtriCure trials.
- Works with the EDC and paper databases to ensure accurate/relevant data entry, reports and data locks.
- Assisting with the development and writing clinical protocols (including IDE protocols).
- Develops and updates CRF’s and worksheets as necessary.
- Assisting with clinical reports (including development/writing IDE progress and annual reports).
- Maintain compliance to and updating all Clinical SOP’s as required.
- Assist with ongoing maintenance of clinical files and regulatory binders.
- Assists with site initiations, investigator trainings and site closeouts.
- Assist with tracking of non-IDE studies and publication efforts.
- Assist with clinical portions of regulatory submissions other than IDE’s.
Qualifications
- Undergraduate degree or equivalent
- 4+ years experience in the field
- Data management and analysis experience
- Problem-solving / trouble-shooting experience
- Excellent computer and data entry skills, including computer networking experience
- Excellent written and verbal communication skills
- Regulatory experience required
- Statistical analysis and use experience desired but not required
- Understanding of the administrative aspects of document management
- Team-oriented and able to effectively manage & prioritize multiple projects
- General knowledge of medical terminology
- SoCRA certification or equivalent
Benefits
AtriCure, Inc. offers a competitive compensation package that includes base salary and stock options. Our benefit package is comprehensive and includes medical insurance, life insurance, dental insurance, and 401k.
To Apply:
Preferred: Please apply via the link below. Please have your resume and cover letter available for upload as a Word 2003-compatible document.
May also fax resume and COVER LETTER to 513-644-1334.
Must have Clinical Research Associate on the cover sheet.
No phone calls, please.