Drew Anderson

Clinical Research Associate

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

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

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.

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.

Bachelor of Science in Biology, Emphasis in Botany, Minor in Environmental Science, 2016 Western Illinois University (WIU), Macomb, Illinois

Barnett International, a division of Cambridge Healthtech Institute, Fall 2020

• Introduction to Clinical Research
• Comprehensive Monitoring for Medical Devices