Customer Service Quality Assurance

NANCY C. HORPER

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

Fairfield, OH 45014

Phone: 513-***-****

E-mail: *******@****.***

EDUCATION

**/**** ******** **** ******* (nka Brown Mackie College),

Fairfield, OH

AAS Medical Assisting Summa Cum Laude

POSITIONS/EXPERIENCE

TriHealth, Cincinnati, OH

10/2012-04/2014 Promoted to Institutional Review Board (IRB) Coordinator

. Responsible for answering the phone, opening the

mail, typing correspondence, and responding to all e-

mails from both the IRB mailbox and my personal

mailbox

. Schedule teleconferences, meetings, tutorials

. Prepare agenda and create and file meeting minutes

. Review all documents for accuracy and maintain all

required records and reports of the IRB to meet the

Food and Drug Administration and Office for Human

Subject Protections regulations governing IRB's

02/2011-10/2012 Clinical Regulatory Assistant (Hatton Institute, Bethesda

North Hospital)

. Communicate with IRB (Trial status, amendments, staff

changes)

. Organize and maintain regulatory binders

. Order department supplies

10/2010-02/2011 Clinical Regulatory Assistant (Dermatology Research

Center of Cincinnati)

. Study submission to the IRB, notification of subject

randomization/enrollment, and meeting deadlines for

progress reports

. Compliance with IRB/FDA deadlines for reporting

deaths, adverse events and serious adverse events

with study subjects

. Create and maintain filing system for trials and

perform periodic audit for file completeness

LBR Regulatory and Clinical Consulting Services, Inc., Crestview Hills, KY

06/2004-02/2009 Senior Regulatory Associate

. Site start-up through study closure activities,

regulatory document collection, data entry, and

maintenance of study files

. Quality control activities including review of

regulatory documents and files

Nancy C. Horper Page 2

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Kendle International Inc. (nka INC Research), Cincinnati, Ohio

06/2002-05/2004 Promoted to Global Clinical Quality Assurance Specialist

. Review all Request for Proposals (RFP) submitted to

Clinical Quality Assurance Department (CQA) and

prepare all global, US, and European bid packages

. Track CQA contracts, budgets, and timelines

01/2001-06/2002 Promoted to Clinical Quality Assurance Assistant

. Prepare and submit all bids (US, European, and

Global) to CQA Manager and Client Services

. Prepare and submit monthly budget review change forms

to Project Managers and Accounting Department

09/1997-12/2000 Regulatory Specialist I

. Edit reports and assist in maintenance and distribution of

protocols with administrative changes and amendments

. Review of expense reports, check requests, purchase orders and

Request for Time Off (RTO) forms

Lawriter Systems, Inc. (nka Lawriter LLC), Cincinnati, Ohio

1992-1997 Editor

Mental Health Services East, Inc. (nka Center for Children and Families),

Cincinnati, Ohio

1990-1992 Promoted to Medical Records Technician

1989-1990 Receptionist

Javier A. Felipe-Morales, MD, Cincinnati, Ohio

1986-1988 Medical Assistant/Receptionist

Suder, Persinger and Malik, MDs, Inc., Cincinnati, Ohio

1985-1986 Receptionist/Administrative Assistant

TECHNICAL SKILLS

. Microsoft Office

. E-mail (Lotus Notes, Outlook)

. Office equipment (Multi-line phone, desktop computer, laptop computer,

copier, scanner, printer, calculator, fax machine, typewriter)

. Intranet and Internet navigation

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