Ashley Yumiko Fesler
Denver,CO
Summary
A detail-oriented and organized oncology research data coordinator with experience in NCORP and community based trials who is seeking an opportunity to utilize this former experience and current skill set as a Research Data Coordinator Supervisor.
Overview
16
16
years of professional experience
Work History
Senior Research Data Coordinator
Rocky Mountain Cancer Center
10.2017 - Current
- Actively manages data extraction, reporting, and query resolution for 15-20 studies at a time.
- Interacts with various health care delivery systems to identify, track, evaluate, analyze, submit, and amend subject data for active and long term follow up subjects. This data may include both paper and electronic data.
- Actively reviews query and expectancy reports to ensure compliance with data entry timelines and accuracy.
- Interacts with various imaging submission platforms to submit scan images and data transmittal forms as required per protocol.
- Schedules and facilitates on-site and remote monitoring visits which includes research subject binder maintenance and PI monitor call scheduling.
- Ensures that all protocol specific and NSOC assessments are billed appropriately for each visit.
- Maintained on-site study kit inventory and shipped out kits to satellite sites as required per protocol.
- Trains new staff on multiple data capture/retrieval systems with specific focus on data extrapolation, data submission, and query resolution.
- Assists the clinical research team in preparation for external audits and is responsible for the quality and completeness of subject data.
- Performs internal chart audits and resolves data queries accurately and expediently.
- Collaborates closely with the Clinical Research Team, which may include Clinical Research Coordinators, Principal Investigators, Sub-Investigators, Pharmacy, and Regulatory personnel to ensure that key federal, state, local, regulatory, and ethical objectives are met.
- Develops and maintains productive relationships with colleagues and all external customers and contacts at affiliate sites to include frequent participation in cross functional teams.
- Ensures adherence to Good Clinical Practices and compliance with all company policies and procedures.
- Responsible for completing and maintaining certification in human subjects training and biosafety training within required time frames.
Lead Clinical Research Associate
Colorado Cancer Research Program
08.2015 - 10.2017
- Interacted with a variety of health care delivery systems to identify, track, evaluate, analyze, submit, and amend subject data. This data may include both paper and electronic data.
- Monitored the data team to ensure compliance while evaluating and abstracting source documentation, case report form completion, database use and management for active data and long term follow up.
- Actively oversaw the query and expectancy report distribution process to ensure compliance with company policies and procedures.
- Responsible for capturing and reporting the data quality and query reporting algorithm to the Quality Assurance Committee.
- Oversaw the processing, tracking, and shipment of biological specimens including tissue and hematology samples to ensure they meet the guidelines set forth by the protocol.
- Trained all new staff on the multiple data capture/retrieval systems with specific focus on data extrapolation, data submission, and query resolution.
- Assisted the Clinical Research Team in preparation for external audits and is responsible for the quality and completeness of subject data.
- Performed internal chart audits and resolves data queries accurately and expediently.
- Collaborated closely with the Clinical Research Team to ensure that key federal, state, local, regulatory, and ethical objectives are met.
- Developed and maintained productive relationships with colleagues and all external customers and contacts at affiliate sites to include frequent participation in cross functional teams.
- Ensured adherence to Good Clinical Practices and compliance with all company policies and procedures.
- Responsible for completing and maintaining certification in human subjects training and biosafety training within required time frames.
Records Coordinator
Jones International University
07.2012 - 06.2015
Enrollment Specialist
Jones International University
05.2010 - 07.2012
Data Entry Specialist
Lakeshore Staffing Company - Western Stone and Metal
06.2009 - 12.2009
Administrative Assistant
National Law Enforcement and Technology Center
10.2007 - 07.2008
Education
Bachelor of Arts - Biological Sciences
University of Denver
Denver2008
High School Diploma -
Kalani High School
Honolulu, HI2004
Skills
- Microsoft Office proficiency
- EDC proficiency (RAVE, InForm, Medrio)
- CREDIT software experience
- iKnowMed EHR experience
- CTMS software experience
- Citrix computer system experience
- Meticulous attention to detail
- Self-directed
- Filing and data archiving
- Strong problem solver
Timeline
Senior Research Data Coordinator
Rocky Mountain Cancer Center
10.2017 - Current
Lead Clinical Research Associate
Colorado Cancer Research Program
08.2015 - 10.2017
Records Coordinator
Jones International University
07.2012 - 06.2015
Enrollment Specialist
Jones International University
05.2010 - 07.2012
Data Entry Specialist
Lakeshore Staffing Company - Western Stone and Metal
06.2009 - 12.2009
Administrative Assistant
National Law Enforcement and Technology Center
10.2007 - 07.2008
Bachelor of Arts - Biological Sciences
University of Denver
High School Diploma -
Kalani High School
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