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 caregivers.• 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 information. • 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; ensuring visit follow-up completion.• 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