Andrea Thompson
St. Louis,MO
Summary
A committed Clinical Research Specialist with over 10 years of clinical research experiance. Skilled in clinical trial design, regulatory compliance, and data analysis. Thrives using critical thinking, communication, and teamwork to exceed project goals. Seeking a challenging position at XYZ Tech, where I can contribute to developing innovative software solutions and grow my expertise in mobile application development.
Overview
15
15
years of professional experience
Work History
Clinical Research Specialist
Washington University in St. Louis
St. Louis, MO
10.2021 - Current
- Serves as a resource for regulatory document preparation, protocol development and regulatory submissions.
- Serves as a resource to clinical research staff ensuring appropriate procedures are followed according to IRB and federal guidelines
- Collaborates with PI to develop, prepare, and submit FDA IND applications
- Manages all aspects of multi-site clinical trial
- Reviews department projects prior to IRB submission
Clinical Core Project Manager
Washington University School of Medicine
St. Louis, MO
09.2019 - 10.2021
- Provided essential support to the Clinical Operations Manager
- Collected critical data for National Institutes of Health (NIH) study renewals
- Created comprehensive reports, SOPs, & monitored program data outcomes
- Assisted in developing and executing project plans and implementation
- Facilitated monthly clinical meetings among cross-functional teams
Lead Clinical Research Coordinator
Mercy Research
St. Louis, MO
08.2018 - 08.2019
- Oversaw site feasibility/study start-up including budget negotiations
- Led team for successful implantation for inpatient IND & IDE studies
- Administered IP and data input into EDC system
- Facilitated preparation of medical device studies for internal audits
- IP and device accountability
Senior Clinical Research Coordinator
Washington University School of Medicine
St. Louis, MO
01.2018 - 07.2018
- Assisted Clinical Center staff in navigating FDA regulatory requirements
- Supported trial activities, site qualification, initiation processes, and training
- Conducted SIVs and monitoring visits for 26 US Clinical Centers as ARO
- Provided guidance to research team to meet study milestones
- Followed ICH-GCP guidelines
- Submitted projects to sIRB
Clinical Research Coordinator II/Regulatory
Washington University School of Medicine
St. Louis, MO
05.2016 - 02.2018
- Assisted with compliant IND submissions to FDA
- Created study documents to ensure accurate data collection for imaging studies
- Corresponded with WU Knight ADRC staff fostering collaborative relationships
- Submitted new studies proposals and continuing reviews to IRB
- Demonstrated expertise in regulatory compliance and GCP
- Trained study staff on various research projects
Clinical Research Coordinator I
Washington University School of Medicine
St. Louis, MO
02.2012 - 05.2016
- Created study protocols, ICFs, and study implementation
- Successfully recruited participants for multiple Emergency Department studies
- Developed and managed REDCap database for efficient study record keeping
- Prepared sponsor invoices for payment
- Served as a primary liaison between study sponsor and study team
- Severed a pivotal role in hiring, training, and supervising Research Assistants
Research Assistant
Washington University School of Medicine
St. Louis, MO
09.2010 - 02.2012
- Enrolled adult and pediatric participants in Traumatic Brain Injury studies
- Managed data collection for retrospective registry studies
- Collaborated closely with research team lead with various project related tasks
- Submitted essential documents for IDE submission to study sponsor
Administrative Clerk I
Washington University School of Medicine
St. Louis, MO
08.2009 - 01.2011
- Supported Residency Program Coordinator with day-to-day office duties
- Reviewed and processed residency program applications
- Ensured compliance with ACGME and credentialing board guidelines
- Conducted data entry tasks to maintain resident evaluations
Education
Masters of Arts - Biology
Washington University in St. Louis
01.2018
Masters of Arts - Nonprofit Management
Washington University in St. Louis
01.2011
Bachelor of Sociology - Sociology | Minor: Chemistry
University of Missouri-St. Louis
01.2008
Skills
- Regulatory compliance
- Proficient in OnCore
- Project management
- Excellent leadership
- Microsoft Office
- Microsoft Excel
- Detail-oriented
- Excellent leadership
- Protocol development
Degree
MA
Timeline
Clinical Research Specialist
Washington University in St. Louis
10.2021 - Current
Clinical Core Project Manager
Washington University School of Medicine
09.2019 - 10.2021
Lead Clinical Research Coordinator
Mercy Research
08.2018 - 08.2019
Senior Clinical Research Coordinator
Washington University School of Medicine
01.2018 - 07.2018
Clinical Research Coordinator II/Regulatory
Washington University School of Medicine
05.2016 - 02.2018
Clinical Research Coordinator I
Washington University School of Medicine
02.2012 - 05.2016
Research Assistant
Washington University School of Medicine
09.2010 - 02.2012
Administrative Clerk I
Washington University School of Medicine
08.2009 - 01.2011
Masters of Arts - Biology
Washington University in St. Louis
Masters of Arts - Nonprofit Management
Washington University in St. Louis
Bachelor of Sociology - Sociology | Minor: Chemistry
University of Missouri-St. Louis