*** **** 903-***-****

Devine, TX ***** abgqca@r.postjobfree.com

m

Cindy A. Rizo

Experience

July 2012- Present Clinical

Trials of Texas

Certified Clinical Research Coordinator II

Clerical duties such as answering telephones, EDC

entry, retrieval of lab reports/ medical records,

filing paperwork, faxing documents, and maintaining

inventory/ ordering of supplies, submission of SAE

reports, drug accountability, creation of source

docs, drug excel spread sheets

phlebotomy, prepare blood smears body fluid slides,

perform ESR, vitals, injections, perform remicade

infusions, scheduling of patients, processes

specimens, and, centrifuges specimens, prepares

specimens for transport to reference/ central

labs, IATA certified.

Completion and submission of Regulatory Documents,

maintaining of regulatory, completion of case

report forms, schedule of events for patients,

patient education, consenting of subjects, and

patient education on administration of study

medication, training of PI's, Sub-I's, and

ancillary staff of the protocol and amendments,

conduction of Pre site, SIV visits, monitoring

visits, query resolution, close-out visits.

QA of subject charts, supervise ancillary staff for

adherence to protocols, chart audititng for

accuracy, ensure timely completion of charts,

Demonstrated time management and the ability to

work toward deadlines

knowledge of GCP, ICH and FDA guidelines

Reviewed and developed a familiarity with the

protocols, such as study proceedings and timelines,

inclusion and exclusion criteria, confidentiality,

and privacy protections

Jan 2010- July 2012

Gastroenterology Research of America

Project Manager/ Trainer/ Certified Clinical

Research Coordinator

Assisting in setting up infrastructure at

additional sites across the USA

Training of additional site staff/ coordinator in

completion and submission of Regulatory Documents,

maintaining of regulatory, completion of case

report forms, schedule of events for patients,

patient education, consenting of subjects, and

patient education on administration of study

medication.

Review and develop a familiarity with the protocols

Monitoring for IIS trials

Creations of source documents, drug logs

Write informed consents and prepare for IRB

submission

Training additional sites through knowledge of GCP,

ICH, and FDA guidelines

Assist sites with regulatory, Pre Site visits,

execution of CDA, execution of feasibility

questionnaires, and first time regulatory

submissions

Aug 2003- July 2012 Gastroenterology Research of

San Antonio

Certified Clinical Research Coordinator/

Supervisor/ Medical Assistant

Clerical duties such as answering telephones, EDC

entry, retrieval of lab reports/ medical records,

filing paperwork, faxing documents, and maintaining

inventory/ ordering of supplies, submission of SAE

reports, drug accountability, creation of source

docs, drug excel spread sheets

phlebotomy, prepare blood smears body fluid slides,

perform ESR, vitals, injections, perform remicade

infusions, scheduling of patients, processes

specimens, and, centrifuges specimens, prepares

specimens for transport to reference/ central

labs, IATA certified.

Completion and submission of Regulatory Documents,

maintaining of regulatory, completion of case

report forms, schedule of events for patients,

patient education, consenting of subjects, and

patient education on administration of study

medication, training of PI's, Sub-I's, and

ancillary staff of the protocol and amendments,

conduction of Pre site, monitoring visits, query

resolution, close-out visits.

QA of subject charts, supervise ancillary staff for

adherence to protocols, chart audititng for

accuracy, ensure timely completion of charts,

Demonstrated time management and the ability to

work toward deadlines

obtained certification through ACRP 2006, Infusion

Certified 2004

knowledge of GCP, ICH and FDA guidelines

Sponsor and FDA audits

Reviewed and developed a familiarity with the

protocols, such as study proceedings and timelines,

inclusion and exclusion criteria, confidentiality,

and privacy protections

2000-2003 Hematology Oncology Ass. Clinic of South

Texas

Research Coordinator Assistant/ Medical Assistant

Completed 1572, case reports forms, schedule of

events for patients, clias for laboratories

Assisting Doctors with bone marrow aspirations,

vitals signs, triage of ill patients, injections,

phlebotomy, injections

Patient education in ACNA clinic

1999-2000 Methodist Hospital

PCA II

Assist Patients post-op with ambulation, input and

output, vitals

Education 1989-1991 Devine High School

1992-1993 San Antonio

College of Medical And Dental Asst

2006- Present ACRP

certification

Completed Collaborative Institutional Training

Initiative (NIH) modules for Human Research -The

required module, Belmont Report and CITI Course

Introduction, and 31 elective modules]

Company/Institution Sponsored Training

Achieving and Maintaining 21 CFR Part 11

Compliance, Validation Associates, Inc.

CLINICAL DRUG

AND EQUIPMENT

STUDIES

Salix- IBS-D

Sanofi- DM I, II

OptiNose- Nasal Polyps

Ulcerative Colitis- BMS Protocol IM129-005

Crohns Colitis- BMS Protocol IM129-008

Amgen - Ulcerative Colitis

Salix IIS- Obesity

Ulcerative Colitis- MOMENTUM Shire- SPD476-409

Chronic Idiopathic Constipation- Albireo A3309-002

GERD- AstraZeneca D9120C00019

Ulcerative Proctitis/ Proctosigmoidits- Salix

BUCF3002

Ulcerative Colitis- Millennium C13006

Crohn's- Millennium C13007

Crohn's- Millennium C13011

Crohn's- Millennium C13008

Crohn's- Long-term Post- Marketing Secure Registry

C87075

Cimzia

Crohn's- Certifi C0743T26

Ustekinumab vs Placebo in Subjects previously

exposed to TNF Antagonist Therapy

Ulcerative Colitis- Cosmo CB-01-02/01

Non-Constipation IBS- Salix RFIB3008

IBS Female ONLY- Pharmos VPI-TOFP-203

IBS-C- Ironwood MCP-103-302

Chronic Constipation- Ironwood MCP-103-303

Chronic constipation/ IBS-C- Ironwood MCP103-305

Ulcerative Colitis- Prometheus 08CP01

IBS-Constipation Protocol ATL1251/038/cl

Ulcerative Colitis- BMS Protocol IM1101108

Ulcerative Colitis- Shire SIMPLE Protocol

SDP476-404

Ulcerative Colitis- QDIEM Protocol 2007021

Crohn's- BMS Protocol IM101084

Crohn's- Novel 8Berlex Protocol 310187

Gerd- TAP Protocol Tak-390 MR Scr

Gerd- ESAI Protocol 301 & 303

Sonic Remicade Protocol C01669797

Ulcerative Colitis- Protocol 197-02-220

Dyspepsia - CHTF919D2302

IBS-D S2413007

IBS-D S3B30040

IBS-D S3B30048

FD CLIN-AGI-001A

Crohn's ELN100226-CD307 ~ Elan Pharmaceuticals

Crohn's ELN100226-CD351~ Elan Pharmaceuticals

Crohn's ELN100226-CD354 ~ Elan Pharmaceuticals

Crohn's C0168T67 ~ Centocor

Crohn's CL-C002-00~ Inflabloc Pharmaceuticals

Crohn's 308180 ~ Berlex Pharmaceuticals

Crohn's CDP870-031 ~ UCB Pharmaceuticals

Crohn's CDP870-033 ~ UCB Pharmaceuticals

Crohn's CDP870-034 ~ UCB Pharmaceuticals

Treat 990474 ~Registry

Treatment of All Grades of Esphagitis

Extra-Esophageal Manifestations of GERD

Publications Charles W. Randall, Carlo M. Taboada, David L.

Stump, Cindy Rizo. A Prospective Analysis of

Tricyclic Antidepressants and Anticholinergics in

the management of Functional and Motility Disorders

of the Esophagus. Gastroenterology 2004: 126 (4);

Supplement A1-A447.

Contact this candidate