Abbott Molecular, Des Plaines, Illinois
Clinical Research Associate (02-09-2021 - Present)
Oversees the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies
- Ensures validity of study by identifying/resolving discrepancies and obtaining missing data and
- Track core lab activities and more complex components of the trial
- Contributes to developing and writing clinical protocols, case report forms, and other study aids for investigational products by addressing issues by interacting with appropriate personnel.
- Maintains expertise in regulations for applicable geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.). Serves as a resource related to clinical trial regulations.
- Ensures timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.
- Conducts in person visits to clinical trial sites to review regulatory compliance and active record collection
Tempus Health, Chicago, Illinois
Equipment Quality Control Technologist (02-04-2019 - 02-04-2021)
Working as an Equipment Quality Control Technologist I oversaw the documentation, maintenance, troubleshooting and general oversight of all equipment within the Clinical laboratory. Was responsible for numerous instruments from manufacturers such as - Illumina, Agilent, Thermo Fisher Scientific, Eppendorf, Perkin Elmer and. Verified equipment quality by tracking performance metrics over time. Other duties included the following
- Created performance qualification tests for instruments being brought into clinical workflow
- Maintained working relationship with manufacturers for service scheduling
- Report significant equipment findings/deviations and system deficiencies to lab management
- Maintain reagent qualification records and manage quality control of reagent inventory
- Completed preventive maintenance (PM), and routine maintenance for all clinically approved molecular laboratory equipment
Pfizer Inc, Lake Forest, Illinois
Laboratory Technician (08/2018 - 01/2019)
Working with the Quality Control group, I supported both GMP and GSP laboratories by creating formulation buffers and mobile phases for HPLC and UPLC sample testing.
- Ordered and cataloged reagents and equipment for entire GMP lab staff.
- Worked with metrology to assist in the relocation and installation of various laboratory instruments.
- Conducted lab audits to ensure compliance with FDA regulations and GMP standards.
V3 Companies, Woodridge, Illinois
Field Ecologist I (5/2016 – 08/2018)
Facilitate site assessments, monitor fields, and compile reports. Manage projects by defining / inputting work orders, organizing daily logs, and assisting with contract administration.
- Recognized for superior performance through full-time position offer after four months as an Intern and promotion within a year of employment.
- Achieved high client satisfaction through effective management and completion of a diverse set of projects.
