Project Manager Medical Assistant
Resume:
Devine, TX ***** **********@*****.**
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