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Data Entry Clinical

Location:
Madison, WI
Posted:
September 13, 2017

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Resume:

Stephanie M. Li

**** ********** **

Madison, Wi, 53714

608-***-****

ac2ajo@r.postjobfree.com

Employment History

.

Dean Foundation, Middleton, Wisconsin Oct 2016-Present

Serve as a site lead for all assigned Phase lll & lV studies ensuring that studies are delivered according to Sponsor requirements on time and to high quality

Develop study recruitment strategies; screen and educate prospective participants.

Schedule and manage patient visits

Oversee source documentation and case report form completion

Administer clinical interviews, utilizing various psychiatric assessment tools

Develop and maintain study materials in compliance with FDA regulations and Good Clinical Practices, including IRB protocol submissions and informed consent

Covance Clinical Development Services, Madison, Wisconsin – 2008 – present Clinical Development Services, Madison, Wisconsin, Oct.2013-Present –Research Technician lll

Responsible for performing activities of clinical trials in Clinical Pharmacology in line with protocol and regulatory requirements.

Train new staff on case report form entry

Collaborate with Data Management at screen review meetings for database build in RAVE

Review source documents to RAVE Database to ensure consistency

Perform and maintain data entry and query resolution timelines

Work with Clinical Research Associates to resolve database and source issues

Clinical Data Analysis and Reporting Organization, Madison, Wisconsin, Feb. 2013-Oct. 2013- Clinical Data Associate l

Responsible for performing clinical data review, query generation / resolution and reconciliation activities to support the delivery of clinical data according to client quality and integrity specifications, project timelines and productivity targets.

Assist in creation of Data Management Plans, Edit Check Specification Documents and Data Entry Guidelines

Maintaining all tasks per the project timelines

Support for 5-10 studies simultaneously

Clinical Development Services, Madison, Wisconsin, 2008-Feb 2013- Research Technician lll

Responsible for performing practical/administrative activities of clinical trials in Clinical Pharmacology in line with protocol and regulatory requirements.

Clinical Development Services, Madison, Wisconsin, 2008-Feb 2013- Research Technician ll

Responsible for performing practical/administrative activities of clinical trials in Clinical Pharmacology in line with protocol and regulatory requirements.

Clinical Development Services, Madison, Wisconsin, 2008-Feb 2013- Research Technician l

Responsible for performing practical/administrative activities of clinical trials in Clinical Pharmacology in line with protocol and regulatory requirements.

Midwest Home Health Care- 2007-Feb 2008

Responsible for the care of patients in home. Assisting with daily activities, ambulation, cooking, cleaning, helps with errands.

Language Capabilities

English

Chinese

Electronic Data Capture Experience

RAVE: 7 Years

RDC: 6 Years

Oracle Clinical: 6 Years

Education

MS, in Marriage and Family Therapy, Edgewood College

Psychology Degree, Upper Iowa University in Madison, Wisconsin

Associate Degree in Liberal Arts Transfer, Madison Area Technical College (MATC), Madison, Wisconsin

Certified Nursing Assistant, Lafollette High School, Madison, Wisconsin



Contact this candidate