Anna (. Email & Phone Number

Chicago, IL, US

Greater Chicago Area

• Managed a 13 site, 699 patient study comparing health-related quality of life (HRQOL) outcomes in older heart failure patients who undergo heart transplantation (HT) or mechanical circulatory support, and their.
• Collaborated with Principal Investigator, Statisticians, and Data Managers to assist in developing abstracts and manuscripts by providing context to bridge the gap between study data entered in EDC and statistical.
• Provided protocol, study, and regulatory guidance by serving as primary study contact and leading monthly study meetings for sites.
• Created case report forms, abstraction guides, and study resources. Additional study resources resulted in a decrease in queries and improved protocol compliance.
• Accountable for all data management activities including SAE and data monitoring, EDC verification, query generation, and maintaining updated regulatory documentation to ensure data accuracy and integrity.

• Lead coordinator on high enrolling and fast paced transcatheter heart valve studies (aortic, tricuspid, and mitral), surgical aortic valve, and pharmaceutical drug studies.
• Successfully completed a high intensity 3-week FDA audit for a surgical aortic valve study with no 483 or warning letter issued.
• Collaborated with large and diverse clinical team consisting of cardiac surgeons, interventional cardiologists, radiologists, cardiology fellows, and nurses to enable successful patient enrollment, protocol compliance.
• Executed completion of study activities per protocol, FDA, GCP, and IRB requirements by determining eligibility requirements; completing informed consent; maintaining detailed source records; timely data entry.
• Mentored and trained new coordinators on transcatheter and surgical heart valve studies enabling new hires to succeed as lead coordinators.
• Selected for and participated in promotional video for Bluhm Cardiovascular Institute 500th TAVR Procedure video. https://www.youtube.com/watch?v=3LvObjIwJXM&t=132s

• Completed project data for large site-initiated registry for cardiac surgery patients including processing, accuracy, analysis, and evaluation of data in half the allotted time to complete the assignment.

Bachelor'S Degree

Certificate In Accounting, Accounting