Assistant Clinical Research

Cierra M. Hall

**** ********** **, **** *** Buffalo Grove, IL 60089 312-***-**** ******.*.****@*****.***

Objective: Highly self-motivated Dr. of bioengineering with almost 10 years of research, science, writing and teaching experience seeking a position as an engineer.

WORK EXPERIENCE

Global Regulatory Affairs Associate, Pfizer/Hospira, Lake Forest, IL June 2017 - Current

Current projects: pre-filled syringe, pre-filled injection pens, IV bags and vials, and a IV related device

Develop and author detailed global regulatory strategy documents for product launch in the US and around the world

Provide regulatory support during FDA audits for DHF and historical regulatory documents

Provide CMC/change control support for an on-market device

Utilize SOPs and other company guidelines to implement procedures at different points in the product lifecycle

Work with design history files, URS/PRS/DDP and other project documents, and participate in risk management planning

Assist group with 356h, CB0, CB30, and other FDA forms

Provide general regulatory guidance to device/drug teams in the US, Asia, South America and Europe

Assure necessary FDA/ISO/ASTM guidance and standards are included for device design

Consider biocompatibility, storage, aging, materials, extractables & leachables, human factors requirements and other aspects of device design during product development

Interface with teams to provide accurate and up to date information to the department

Work with quality engineering, systems engineering, human factors engineering, pharma, and other groups to ensure the best regulatory strategies are implemented

Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL January 2017 – June 2017

(Cooperation with industry partner Bose)

Senior Clinical Research Coordinator

Took clinical research device project from almost a halt to surpassing expectations on data yield and participant enrollment

Troubleshot experimental hearing device for both doctors and patients, created SOPs for troubleshooting and device usage

Reviewed project and protocol and recommended implemented to expedite hearing device study

Recruited, and retained participants to use experimental hearing device

Accurately applied inclusion/exclusion criteria to subject population and taught them how to use the device

Carefully collected, compiled, tabulated and processed subject responses

Extracted and analyzed data from medical charts following HIPAA protocol

Proactively discovered new subject sets to invite to participate in the study (ex: Researchmatch.org)

Compiled weekly subject data and timeline reports for our industry partner Bose

Office of Technology Management at UIC, Chicago, IL August 2016 – January 2017

Graduate Assistant to Agreement Specialist

Accurately processed and routed licenses, non-disclosure agreements, as well as other contracts and agreements including intellectual property and other patent related forms

Created SOPs for administration of contracts in Sophia system software

Manage invention, intellectual property, contractual agreements, marketing and financial data in an online database (Sophia)

Carefully managed financial agreements including license fees, milestone payments, royalties and other receivables

Performed market and commercial analysis on new discoveries and pending patent applications

Compile monthly and annual reports for the Office of the Vice President for Research and Illinois Science & Technology Coalition

RESEARCH EXPERIENCE

Graduate Research Assistant – PI: Jason McAnany

University of Illinois at Chicago August 2012 – December 2016

Investigator 101, CITI and HIPAA certified

Selected patients based on chosen inclusion/exclusion criteria

Coordinated and conducted contrast threshold and acuity experiments with patients

Accomplished experimental design and development of research strategies

Collaborated with post-doctoral fellow and PI on other projects by testing apparatuses, carefully calibrating machinery, and participating in experiments

Performed accurate and detailed data analysis in Excel, SigmaPlot and MATLAB

Supervised undergraduate students and instructed them on experimental procedures

Ensured proper maintenance and calibration of apparatuses and computing systems, minimizing error

Ultimately designed and implemented a novel noise-based method for contrast threshold testing targeting post-receptor pathways for use with patient populations

TEACHING EXPERIENCE

Teaching Assistant

BIOS 100 –Biology of Cells and Organisms January 2015 – May 2015

Teaching Assistant

BIOE 431– Bioinstrumentation Laboratory January 2014 – May 2014 & January 2012 – May 2012

Taught students how to assemble circuits from individual components to create devices such as heart rate monitors

Teaching Assistant (2 semesters)

PHYS 106 – Mechanics August 2012 – May 2013

Teaching Assistant

BIOE 101 – Introduction to Bioengineering August 2011 – December 2011

EDUCATION

University of Illinois-Chicago, Chicago, Illinois

Doctorate of Philosophy in Bioengineering

Thesis: A Luminance Noise Approach to Target Post-Receptor Visual Pathways; Application to Optic Nerve Disease

Graduation Date: December 2016

GPA: 3.55/4.0

University of Illinois-Chicago, Chicago, Illinois

Bachelor of Science in Bioengineering, Spring 2011

Senior Design Project: Rational Design of a Decision-Making Tool for Brain Surgeons

PUBLICATIONS

Cierra Hall, Andrej Mošať, Eric Lueshen, and Andreas A. Linninger. Interspecies Scaling in Pharmacokinetics: A Novel Whole Body Physiologically-Based Modeling Framework to Discover Drug Biodistribution Mechanisms In Vivo. Journal of Pharmaceutical Sciences. 2012.

Andrej Mošat’, Eric Lueshen, Martina Heitzig, Cierra Hall, Andreas A. Linninger, Gürkan Sin, Rafiqul Gani. First principles pharmacokinetic modeling: A quantitative study on Cyclosporin. Computers and Chemical Engineering. 2013.

Cierra Hall, Shu Wang, Reem Bhagat and J. Jason McAnany. Effect of luminance noise on the object frequencies mediating letter identification. Frontiers in Psychology. 2014.

Cierra Hall, Shu Wang, J. Jason McAnany. Individual Letter Contrast Thresholds: Effect of Object Frequency and Noise. Optometry & Vision Science. 2015.

Cierra Hall. Visual Luminance Noise as a Tool to Target Post-Receptor Visual Pathways. Dissertation, 2016.

Cierra Hall, J. Jason McAnany. Center Object Frequency for Asynchronous Letters in Static and Dynamic Noise Compared to Steady- and Pulsed-Pedestal Paradigms as a Function of Letter Size. Soon to be in press, 2017.

EXTRA-CURRICULAR ACTIVITIES

University of Illinois Bioengineering Student Journal

Editor In Chief, Associate Editor January 2012 – May 2017

Managed paper review, revision and submission of student submitted articles in accordance with journal format

Delegated responsibility to fellow student editors

Coordinated and assembled final draft of semester publication, in tandem with other members, contributors and artists

Coordinated end of semester journal release celebration including successful budget proposal and resource allocation

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