1. Shari Touger
3924 Rock Creek Drive
Birmingham, AL 35223
(205) 249-8732
Stouger0608@gmail.com
EDUCATION
1992
1989
M.P.H. Health Policy and Management- Emory University
B.S. in Exercise Physiology: Health Promotions and Corporate
Wellness- University of Florida
EXPERIENCE
2014-2016 Senior CRA/Clinical Lead Support
SynteractHCR
Birmingham, AL
• Provide clinical lead support and project coordination for
oncology trial.
• Monitor enrollment activities and subject eligibility on a daily
basis to ensure protocol requirements are met for over 60 sites.
• Responsible for vendor management activities, query resolution
and communications relating to lab and diagnostic testing and
drug manufacturer.
• Effectively communicate, on a regular basis with sponsors,
sites, and colleagues to ensure effective project management,
meeting sponsor metrics at 100%.
• Review monitoring visit reports, site status reports and query
resolution reports for a team of 10 CRAs.
• Facilitate corrective action plans and reports with quality
assurance team to ensure protocol violations/deviations were
properly reported, accessed, and addressed.

2. 2012-2014
2000- 2012
Senior CRA , III
Quintiles, GFR
Birmingham, AL
• Provided site management and project coordination for Phase
II-IV clinical trials.
• Monitored activities at clinical study sites to assure adherence
to Good Clinical Practices (GCPs), SOPs, and study protocols.
• Conducted qualification, initiation, interim, and close-out
monitoring visits in compliance with good clinical practices and
FDA regulations.
• Communicated, on a regular basis with sponsors, sites, and
colleagues to ensure effective project management.
• Administered protocol and related study training to assigned
sites and establish regular lines of communication with sites to
manage ongoing project expectations and issues.
• Consistently met data timelines, metrics, and study goals.
• Proficient in Medidata Rave and e-Clinical.
Site Director/Owner
Innovative Clinical Trials, LLC
Birmingham, AL
• Owned and operated self started clinical research site conducting
over 200 protocols in large range of therapeutic areas with both
US and Global CROs and Sponsor.
• Developed business relationships and negotiates contracts with
sponsors, vendors, and marketing teams leading to effective
clinical operations continuously leading to repeat business.
• Ensured that staff is appropriately allocated to assigned
project(s), adheres to professional standards, meets sponsor
timelines and SOPs, and always strives to meet recruitment goals
with quality performance and data.
• Trained and managed research staff to ensure quality data
collection, CRF completion, and source documentation for all
protocols.
• Acted as a consultant to other clinical research sites to train and
implement recruitment strategies, marketing and business plans
leading to successful operations.

3. 1997- 2000 Lead CRA/Clinical Research Associate
Clinimetrics Research Associates, Inc.
Atlanta, GA
• Provided site management and project coordination for Phase
II-IV clinical trials.
• Responsible for management of trip reports, study timelines,
expense reports, schedules, work load management and conflict
resolution for a team of 10 CRAs.
• Monitored activities at clinical study sites to assure adherence
to Good Clinical Practices (GCPs), SOPs, and study protocols.
• Conducted qualification, initiation, interim, and close-out
monitoring visits in compliance with good clinical practices and
FDA regulations.
• Communicated, on a regular basis with sponsors, sites, and
colleagues to ensure effective project management.
• Administered protocol and related study training to assigned
sites and establish regular lines of communication with sites to
manage ongoing project expectations and issues.
1995-1997
1995-1995
Project Manager
The Prudential Center for Healthcare Research
Atlanta, GA
• Managed, analyzed, and extracted research data.
• Exceeded patient enrollment goal by 35%.
• Led project teams toward improved operations.
Clinical Operations Manager
InSite Clinical Trials
Atlanta, GA
• Managed daily operations for clinical research company.
• Coordinated the implementation of more than 30 protocols.
• Coordinated team building efforts to maximize patient
enrollment.
• Recruited and trained healthcare professionals.

4. 1993-1995 Project Manager
Grady Health Systems
Atlanta, GA
• Supervised and coordinated all aspects of a grant funded clinical
research trials.
• Responsible for daily operations of clinic, project management,
and data analysis.
• Exceeded patient enrollment goal by 25%.
• Marketed research project to house staff of 170 physicians.
1992-1993 Project Coordinator
Centers for Disease Control/Fulton County
Atlanta, GA
• Supervised and coordinated all clinic activities for grant-funded
teen clinic research program;
• Enrolled 650 patients into Fulton County Teen Research and
Health Education Program;
• Developed tracking program leading to 75% follow-up;
• Coordinated projects resulting in more efficient patient
enrollment and scheduling.
• The Association of Clinical Research Professionals (ACRP)
• Ahluwalia J., Bell S, McNagney S. A Randomized Controlled
Trial in Smoking Cessation in African Americans.
Research Studie s
market e d , manag e d ,
and recruited as Owner/
Site Director “XXX Cardiovascular Treatment Assessment Versus
XXX”,
2000.
“An Open, Randomized, Parallel-Group, Multicenter Trial to
Compare a Stratified Care Treatment Regimen based on Migraine
Disability (MIDAS grade) versus Standard Therapy for the Acute
Treatment of Migraine Headache”, 2000.
“XXX Dose response, efficacy, and safety: a 12 week randomized,
multi-center, double-blind, double-dummy, parallel-group study of
metformin and five doses of XXX in previously treated OHA
monotherapy obese subjects with Type II Diabetes.”, 2001

5. “A randomized, double blind, double dummy, multicenter, parallel
group study to assess the efficacy and safety of XXX twice daily
versus XXX twice daily for 7 days in the treatment of adults with
bacterial community Pneumonia”., 2001
“An open non-comparative multicenter study to assess the efficacy
and safety of XXX twice daily for 10 days in the treatment of acute
bacterial sinusitis”., 2001
“A double blind, placebo controlled, parallel group study to
evaluate the role of XXX in improving the control patients
previously treated with XXX as monotherapy.”, 2001
“Research of the effects of XXX tablets in hypersensitive subjects
in a community trial: A twelve week multicenter study on the
efficacy and safety of XXX Tablets, an ACE inhibitor, on blood
pressure in hypertensive subjects.”, 2001
“A double-blind, placebo-controlled, parallel group study to
evaluate the role of XXX in improving the control of patients
previously treated with XXX.”
“A-HeFT (African-American Heart Failure Trial) A placebo-
controlled trial of XXX added to standard therapy in African-
American patients with heart failure.”
“A 26 week, randomized, double blind, active-controlled, multi-
center, parallel group study to evaluate the gastrointestinal safety of
XXX compared to XXX in patients with osteoarthritis of the knee.
(WOMAC)
“A prospective, randomized, multicenter, open-label, comparative
safety study of XXX vs. XXX plus ribavirin treatment vs. a 12-
week treatment delay in patients with chronic hepatitis C.
“XXX vs XXX comparative efficacy and safety: an open-label,
randomized, parallel group, multicenter study in the treatment of
subjects with type 2 diabetes inadequately treated with diet and
exercise.”, 2001
“XXX vs XXX in combination with XXX, comparative efficacy
and safety: an open-label, randomized, parallel group, multicenter
study in the treatment of subjects with type 2 diabetes inadequately
controlled with sulfonylurea or metformin monotherapy or low-
dose Glucovance.”, 2001

6. “A double-blind, placebo-controlled, parallel group comparison
study to evaluate the role of the addition of XXX to NIDDM
patients not responding to Metformin or TZD therapy.”, 2001
“A double-blind, placebo-controlled, parallel group comparison
study to evaluate the role of the addition of XXX to NIDDM
patients not responding to Avandia as monotherapy.”, 2001
“A 6-Week, Randomized, Open-Label, Comparative Study to
Evaluate the Efficacy and Safety of XXX and XXX in the treatment
of Hypercholesterolemia in African American Subjects”. (ARIES),
2002
“A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Short-
Term, Dose-Response Study to Examine the Effect on Glucose
Control and Safety and Tolerability of XXX Given Two Times a
day in Subjects with Type 2 Diabetes”., 2002
“A 12-Week Randomized, Double-Blind, Placebo Controlled
Multicenter Study of the Analgesic Efficacy of XXX Compared to
Placebo in Patients with Chronic Low Back Pain.”, 2002
“A Double-Blind, Multi-Center, Randomized, Placebo-Controlled,
Parallel Group Dosing Study Evaluating The Effects of XXX on
Blood Pressure in Patients with Mild to Moderate Hypertension”,
2002
“A Phase III Randomized, Multicenter Study Comparing the Safety
and Efficacy of Oral XXX versus XXX in Subjects with Gout”,
2002
“A Randomized, Double-Blind, Placebo-Controlled, Parallel-
Group, Multicenter, 12-Week Study Assessing the Effects of XXX
on Vasomotor Symptoms in Postmenopausal Women of Minority
Ethnic Groups”, 2002
“A Phase II, Randomized, Double-Blind, Placebo-Controlled,
Dose-Finding Study of XXX in Subjects with Diabetic
Neuropathy”, 2002
“A Nine-Month Placebo Controlled Phase II Extension Study of
XXX in Subjects with Diabetic Neuropathy”, 2002
“A 12 Week, Randomized, Double-Blind, Placebo-Controlled,
Fixed-Dose, Parallell Group, Multicenter, Study of the Safety and
Efficacy of XXX BID andTID In Female Patients with Constipation
Pre-dominant Irritable Bowel Syndrome”, 2002

7. “An Open-Label Extension of Study XXX to Investigate The
Long-Term Safety and Efficacy of XXX TID In Female Patients
with Constipation Pre-dominant Irritable Bowel Syndrome”, 2002
“A Phase 2, Randomized, Triple-Blind, Placebo-Controlled,
Short-Term, Dose-Response Study to Examine the Effect on
Glucose Control and Safety and Tolerability of XXX Given Two
Times a Day in Subjects With Type 2 Diabetes Mellitus”, 2003
“A Randomized, Multi-center, Double-Blind, Parallel Group Study
to Determine the Efficacy and Safety of Lotrel versus Enalapril in
the Treatment of Hypertension in African-American Population
with Type 2 Diabetes”, 2003
“A Multicenter, Randomized, Double-Blind, Parallel-Group,
Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone
(2mg and 4mg) Compared to Insulin Plus Placebo for 24 Weeks in
Subjects with Type 2 Diabetes Mellitus Who Are Inadequately
Controlled On Insulin”, 2003
"A 28 day, double blind, placebo-controlled, paralle-group, dose-
ranging, Phase IIa study to examine the safety, tolerability, and
effects of SB-480848 on Lp-PLA2 activity in dyslipidemic
patients”, 2003
“A Multi-center, Double-Blind, Randomized, Placebo-Controlled,
Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety
of Ezetimibe 10 mg/day When Added to Ongoing Therapy with a
Statin Versus Statin Therapy Alone, in Patients with
Hypercholesterolemia Who Have Not Reached National
Cholesterol Education Program (NCEP) Adult Treatment Panal
(ATP) III Target LDL-Cholesterol Level.”, 2003
“A Randomized, Double-Blind, Placebo-Controlled, Parallel-
Group, Fixed-Dose, Multicenter Study Of Weight-Reducing Effect
and Safety of XXX in Obese Patients With Type 2 Diabetes”, 2004
“An Epidemiologic Study of the Prevalence fo Vitamin D
Insufficiency and Deficiancy in Postmenopausal Women on
Therapy to Treat of Prevent Osteoporosis”, 2004
“A Double-Blind, Randomized, Controlled, Parallel-Group,
Multicenter Study Evaluating the Safety and Efficacy of XXX As a
Treatment in Subjects With Osteoarthritis in the Knee”, 2004
(WOMAC)

8. “The Efficacy and Safety of XXX and XXX in Patients with
Hypertension Uncontrolled on Monotherapy”, 2004
“An Open-Label Study to Examine the Long-Term Effect on
Glucose Control (HbA1c) and Safety and Tolerability of XXX
Given Two Times a Day to Subjects With Type 2 Diabetes
Mellitus”, 2004
“A Multicenter, Randomized, Double-Blind, Parallel-Group,
Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone
(2mg and 4mg) Compared to Insulin Plus
“The Efficacy and Safety of XXX and XXX in Patients with
Hypertension Uncontrolled on Monotherapy”, 2004
“An Open-Label Study to Examine the Long-Term Effect on
Glucose Control
(HbA1c) and Safety and Tolerability of XXXGiven Two Times a
Day to Subjects With Type 2 Diabetes Mellitus”, 2004
“A Multicenter, Randomized, Double-Blind, Active, and Placebo
Controlled, Phase III, Efficacy and Safety Study of XXX and XXX
in Patients with Moderate to Severe Chronic Pain Due to
Osteoarthritis of the Hip or Knee”, 2004 (WOMAC)
“A Double-Blind, Randomized, Placedo and Active Controlled,
Forced Titration Study Evaluating the Effects of XXX on Blood
Pressure and Heart Rate in African Americans with Hypertension”,
2005
“A Phase III, 12 week, multicenter, double-blind, double-dummy,
randomized, Placebo and Active Comparator-controlled, parallel
group study to investigate the efficacy and safety of XXX
administered orally once daily”, 2005
“A 26 week, multicenter, open-label, parallel group 2:1 randomized
treat to target trial comapring efficacy and safety of XXX using
XXX with as mealtime insulin in subjects with Type 2 Diabetes”,
2005
“A multicenter, randomized, double-blind, active and placebo
controlled Phase III, efficacy and safety study of XXX and XXX in
patients with moderate to severe chronic pain due to osteoarthritis
of the knee”, 2005 (WOMAC)

9. “A phase III randomized, mutlticenter, XXX and XXX assessing
the safety and tolerabilty of of XXX in subjects with Gout”, 2005
“A phase 3 study of the efficacy and safety of XXX: A parallel,
randomized, double blid, 13 week placebo controlled and
naproxen-controlled study of XXX in patients with osteoarthritis of
the knee”, 2006
“A Double-Blind, Randomized, Parallel-‘Group, Multi-Center
Study to Compare Clinical Health Outcomes of XXX vs XXX in
outpatients with Community Acquired Lower Respiratory
Infections”, 2006
“A 24 week Double-Blind, Randomized, Parallel-‘Group, Multi-
Center Study to evaluate the efficacy, safety and tolerability of oral
XXX when added to the therapy of patients with Type II Diabetes
on insulin”, 2006
“An open-label Evaluation of the safety and efficacy of a
combination of XXX and XXX in patients with Dyslipidemia”,
2006
“XXX vs XXX in Subjects with Type 2 Diabetes and inadequate
glycemic control on Basal Insulin plus oral antidiabetic therapy”,
2006
“A Phase III pivotal, multicenter, double-blind, randomized,
placebo controlled monotherapy study of XXX for the treatment of
Fibromyalgia”, 2006
“A 24 week Double-Blind, Randomized, Parallel-‘Group, Multi-
Center Study to evaluate the efficacy, safety and tolerability of oral
XXX when added to the therapy of patients with Type II Diabetes
on TZDs”, 2007
“A 24 week Double-Blind, Randomized, Parallel-‘Group, Multi-
Center Study to evaluate the efficacy, safety and tolerability of oral
XXX when added to the therapy of patients with Type II Diabetes
on secretagogues”, 2007
“A 24 week Double-Blind, Randomized, Parallel-‘Group, Multi-
Center Study to evaluate the efficacy, safety and tolerability of oral
XXX when added to the therapy of patients with Type II Diabetes
on metformin monotherapy”, 2007

10. “An open label, multi-center, long-term extension study to evaluate
the safety and tolerability of oral XXX when added to the therapy
of patients with Type II Diabetes”, 2007
“A phase III Open-label study to assess the long term safety of
XXX in subjects with Gout”, 2007
“A multicenter, randomized, double-blind, placebo controlled study
of the Safety and Tolerabililty of XXX as monotherapy for Type 2
Diabetes”, 2007
“A 12-Week, Multicenter, Randomized, Double-Blind, Parallel-
Group Study of the Combination of ABT-335 and Rosuvastatin
Compared to ABT-335 and Rosuvastatin Monotherapy in Subjects
with Type IIa and IIb Dyslipidemia”, 2007
“One vs Two vs three daily rapid-acting insulin injections of XXX
as add-on to XXX and oral sensitizer basal therapy in Type 2
Diabetes”, 2008
“A Randomized, Double-Blind, Placebo-Controlled Study to
Assess the Safety and Efficacy of XXX in Patients with Type 2
Diabetes Inadequately Controlled on Metformin Alone”, 2008
"A Phase III Pivotal, Multi-center, Double-blind, Randomized,
Placebo-Controlled Monotherapy Study of XXX for the Treatment
of Fibromyalgia" 2008
“A phase 2, double-blind, randomized, placebo-controlled, parallel
group, multicenter study to evaluate treatment with XXX in
subjects with type 2 diabetes.”, 2008
“A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-
Controlled Study Assessing the Efficacy and Safety of Oral XXXin
Subjects with Gout.”, 2008
“Tolerability of XXX Compared to XXX in Patients with Mild-
Moderate Hypertension on Hydrochlorothiazide.”, 2008
“A 7-Week, Phase 2, Multicenter, Double-Blind, Randomized,
Parallel-Group study, to Evaluate the Effects of XXX (750 mg,
bid), and Ibuprofen (600 mg, tid) on Arterial Blood Pressure as
Measured by Ambulatory Blood Pressure Monitoring in
Osteoarthritis Patients with Controlled Essential Hypertension”,
2008
“A Randomized, Double-Blind, Placebo-Controlled Study to
Assess the Safety and Efficacy of XXX in Patients with Type 2
Diabetes Inadequately Controlled on Metformin Alone”, 2008

11. "A Double -Blind, Randomized, Placebo-Controlled Dose
Escalation Study of XXX100 MG and 200 MG Daily in Patients
with Fibromyalgia: Effects on 24-Hour Ambulatory Blood Pressure
Monitoring" 2008
“Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,
Multicenter Study to Determine the Efficacy and Safety of XXX
When Used in Combination with XXX With or Without Metformin
in Subjects with Type 2 Diabetes Mellitus”, 2009
“Randomized, Double-Blind, Placebo-Controlled and Active
Controlled, Parallel-Group, Multicenter Study to Determine the
Efficacy and Safety of XXX When Used in Combination with XXX
and XXX Compared With Metformin Plus Glimepeiride and
Placebo and With Metformin Plus Glimeperide and Pioglitazone in
Subjects with Type 2 Diabetes Mellitus”, 2009
“A randomised, double-blind, placebo-controlled, parallel group
efficacy and safety study of XXX, administered orally once daily
for 18 weeks followed by a 34 week double-blind extension period”
(placebo patients switched to glimepiride) in type 2 diabetic patients
with insufficient glycaemic control for whom metformin therapy is
inappropriate (intolerability or contraindication), 2009.
"A Multicenter, Randomized, Open-Label, Controlled Study to
Evaluate the Safety, Tolerability, and Efficacy of XXX When
Added to XXX in the Treatment of Fibromyalgia", 2009
“A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-
CONTROLLED, MULTICENTER STUDY TO ASSESS THE
EFFICACY AND SAFETY OF RIFAXIMIN 550 mg TID IN THE
TREATMENT OF SUBJECTS WITH NON-CONSTIPATION
IRRITABLE BOWEL SYNDROME”, 2009
“A Phase II, Randomized, DOuble-blind, Placebo-controlled,
Multi-center, Parallel Group Study Evaluating the Efficacy, Safety
and Tolerability of XXX Administered Twice Daily for 24 Weeks in
Treatment-naïve, Metformin Only or Metformin plus Sulfonylurea-
treated Obese Type 2 DiabEtic Patients (PROMOTE)”, 2009
“An efficacy and safety study of XXX compared with a concurrent
placebo control in subjects with neuropathic pain associated with
post-herpatic neuralgia”, 2009

12. “A dose-response study of XXX compared with concurrent placebo
control and XXX in subjects with neuropathic pain associated with
diabetic perifperhal neuropathy”, 2009
“” A Phase II, Randomized, Double-Blind, Placebo-controlled,
Multi- Center, ParALlel Group Study Evaluating the Efficacy,
Safety ANd PharmaCokinetics of JTT-654 Administered for 12
Weeks in Untreated or Metformin-treated TypE 2 Diabetic Patients
(BALANCE)., 2010
“”A randomised, double-blind, placebo-controlled parallel group
efficacy and safety study of BI 1356 (5 mg administered orally
once daily) over 18 weeks in Type 2 diabetic patients with
insufficient glycaemic control (HbA1c 7.0-10%) despite
background therapy with a sulfonylurea drug, 2010
“A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Discontinuation Study to Evaluate the Durability of Effect of
Milnacipran for the Treatment of Fibromyalgia in Patients With
Long Term Milnacipran Treatment”, “2010
“”A Phase 3, Randomized, Double-blind, Placebo-controlled,
Parallel-group Trial of Linaclotide Administered Orally for 12
Weeks in Patients with Chronic Constipation, “2010
“A Phase 3, Double-Blind, Randomized, Efficacy and Safety Study
of the TAK-491 Plus Cholorthalidone Fixed-Dose
Combination Compared With TAK-491 and Hydrocholorthiazicde
Coadministration in Subjects With Moderate to Severe Essential
Hypertension,” 2010
“A 26 week randomised, open labelled, parallel group, multi-
national, treat-to-target trial comparing efficacy and safety of XXX
once daily in combination with XXX and XXX versus XXX and
XXX with or without sulphonylurea, in subjects with type 2
diabetes”, 2011
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group,
Multicenter Study to Determine the Efficacy and Safety of XXX
When Used in Combination with XXX Alone or XXX Plus XXX in
Subjects with Type 2 Diabetes Mellitus”, 2011
“A Randomized, Double-Blind, Placebo-Controlled, Parallel-
Group, Multicenter Study to Determine the Efficacy and Safety of
XXX When Used in Combination With XXX With or Without
Metformin in Subjects with Type 2 Diabetes Mellitus”, 2011

13. “A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-
Controlled Study to Investigate the Safety and Efficacy of XXX
Extended Release (G-ER) Tablets in the Treatment of Vasomotor
Symptoms in Postmenopausal Women”, 2011
“A Long-Term, Open-Label Extension Study to Investigate the
Long-Term Safety of XXX) in Subjects with Type 2 Diabetes”,
2011
“An Open-label, Long-term Safety Study of Oral XXX
Administered to Patients with Chronic Constipation or Irritable
Bowel Syndrome with Constipation”, 2011
"A randomized, double-blind, placebo-controlled, 2-arm parallel-
group, multicenter study with a 24-week main treatment period and
an extension assessing the efficacy and safety of XXX on top of
XXX in patients with type 2 diabetes not adequately controlled
with XXX" 2011
A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-
center, Parallel Group Study Evaluating the Efficacy, Safety and
Tolerability of XXX Administered Twice Daily for 24 Weeks in
Treatment-naïve, Metformin Only or Metformin plus Sulfonylurea-
treated Obese Type 2 DiabEtic Patients (PROMOTE), 2011
“A Multicenter, Randomized, Parallel-Group, Double-Blind,
Placebo and Active Controlled Phase 2 Dose Finding Study
Comparing the Safety, Tolerance, and Efficacy of Various Doses of
SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not
Well-Controlled on Metformin Therapy”, 2011
“A Double-Blind, Randomized, Multicenter Study of Prasugrel
Compared to Placebo in Adult Patients with Sickle Cell Disease”,
2011