Clinical Research Quality Control

Makenzie A. Nelson

**** **** ***. * ● Fargo, ND *8104 ● 320-***-**** ● **********@*******.***

OBJECTIVE To obtain a position where I can utilize my knowledge, abilities, and experience.

EDUCATION Minnesota State University Moorhead Moorhead, MN

Bachelor of Arts Psychology, May 2005

Bachelor of Arts Criminal Justice, May 2005

Minor Women’s Studies, May 2005

CERTIFICATION 2009–Present

Certified Clinical Research Coordinator

Association of Clinical Research Professionals

EXPERIENCE Clinical Research Coordinator/Project Lead Fargo, ND

2009–2013

PRACS Institute/Cetero Research

Accountable for overseeing all aspects of Phase I, Phase III Dermatology and

Pre-Clinical trials from pre-initiation to close-out

Performing health screens on clinical trial participants

Reviewing and preparing paperwork for Phase I and Phase III Dermatology trials

Reviewing study protocols, informed consent documents and participant charts

Liaison between pharmaceutical sponsors and Principal Investigators, Sub-

Investigators and clinical research team members

Scheduling meetings to ensure proper training on protocols

Managing, coordinating and training support staff including clinical research

coordinator associates, phlebotomists, nursing staff and safety monitors

Accurately maintain and review study documentation in case report forms and

clinical research binders

Assisting Quality Control in reviewing regulatory documents, ICF documents,

participant charts, study documentation, AEs, and EDC and paper CRFs

Effectively managed clinical trials within the contracted amount of time

Clinical Study Monitor/Project Lead Fargo, ND

2007–2009

Cetero Research

Accountable for overseeing all aspects of Phase I trials from pre-initiation to

close-out

Liaison between pharmaceutical sponsors and Principal Investigators, Sub -

Investigators and clinical research team members

Reviewing study protocols, informed consent documents and participant charts

Accurately maintain and review study documentation in case rep ort forms and

clinical research binders

Effectively managed clinical trials within the contracted amount of time

Supervised and trained clinical research coordinator associates and support staff

Psychiatric Technician Fargo, ND

Prairie St. John’s 2005-2007

Monitoring patients’ actions and behavior and record progress in chart

Lead/co-lead group sessions

Correspond with psychiatrists, addiction counselors and social workers

regarding treatment plans

-Proficient computer skills in Microsoft Office Suite, Study Monitor, E-Scribe, LabDAQ

SKILLS AND

-Clinical research experience in Phase I, Phase III Dermatology and Pre -Clinical

INTERESTS

-Proper knowledge of GCP, GDP and other regulations as they pertain to clinical studies

-Excellent communication skills with clients and fellow staff

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