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Clinical Research Assistant

Location:
Hudson, WI
Posted:
June 19, 2020

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Resume:

PROFESSIONAL PROFILE

Results-driven achiever.

Flexible and adaptable to a variety of diverse environments.

Works well in both team and individual settings.

Exceptionally motivated research professional and problem-solver who works hard.

Strong interest and background in Clinical, Regulatory and Quality departments.

EDUCATION

Bachelor of Science Degree in Cellular & Molecular Biology

Winona State University, Winona, Minnesota, May 2015

Academic Dean’s List

Recipient of University Academic Scholarship

PROFESSIONAL SKILLS AND ABILITIES

Experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practices (GMP).

Proficient in Microsoft Office Suite.

Basic Understanding of FDA Regulations.

High attention to detail and accuracy.

Demonstrated communication skills, both written and verbal.

Experience working with clinical trial management systems and clinical document control systems/eTMF

WORK EXPERIENCE

HealthPartners Institute Bloomington, MN

Research Subjects Protection Coordinator October 2019-Present

A Research Subjects Protection Coordinator is the primary contact for investigators and research staff to work through Institutional Review Board (IRB) submissions. Additionally, responsible for conducting the pre-review for all research project submissions. Also provide audit management compliance consulting, and quality trending reporting.

Medtronic (contracted through Integrated Resources, Inc.) Mounds View, MN

Associate Clinical Research Specialist January 2019-June 2019

An Associate Clinical Research Specialist assists with the overall conduct of assigned clinical studies in accordance with applicable regulations, guidelines and policies. Heavily involved in CTMS and eTMF document management, filing and quality review of clinical records. Collaborate with study leadership to assure high quality and successful project delivery.

Regions Hospital Saint Paul, MN

Lab Services Technician April 2018-December 2018

A Lab Services Technician is responsible for performing phlebotomy on patients in a hospital setting. Responsible for processing and routing laboratory samples to their desired department for testing.

Prism Clinical Research Saint Paul, MN

Clinical Research Assistant April 2016-March 2018

As a Clinical Research Assistant, I was responsible for executing all procedures throughout trial conduction to ensure ICH/GCP and other regulatory and protocol requirements were being met. Schedule and conduct patient visits, perform data entry into EDC, maintain regulatory binder, draw blood, collect vital signs, process and ship laboratory samples, etc.



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