Quality Assurance Safety

JEFFREY M. GARNER

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

Boca Raton, FL 33498

Ph. 561-***-**** Cell 561-***-****

E-mail: abm80j@r.postjobfree.com

FibroGen

San Francisco, CA Nov-2008

May-2009

May 2009

Regional Senior CRA/Pharmaceutical Consultant

Currently involved in the implementation of "A Randomized Double-blind,

Placebo Controlled, Phase 1, Study of Safety, Pharmacokinetics and

Pharmacodynamics of FG-3019 in Subjects with Type 1 or Type 2 Diabetes

Mellitus and Diabetic Nephropathy on Background ACEi and/or ARB Therapy".

This Investigational product is a new and unique Monoclonal Antibody which

is being produced and researched solely by the Biotech Group XXXXXXX

Experience:

I3 Research

RTP, NC 2006-2008

Regional Senior CRA/Pharmaceutical Consultant

Review clinical data to insure accuracy, completion and integrity of data

Compare source documentation against case report forms

Maintain a working knowledge and assure compliance with the GCP, ICH and

Sponsors SOP's

Assure the supply and account for the disposition of clinical materials

Report/disseminate all adverse reaction information in a timely manner as

defined by the Sponsor and the FDA

Attend Investigator Meetings

GCP and SOP training of site staff members

Complete monitoring and other routine reports as required

Qualify potential investigators

Interact with investigators to obtain pre-study administrative packets

Initiate investigational sites

Conduct investigational site termination visits

Serve as lead contact for the study team and clinical sites

Present at the investigators meeting

Conduct report review

Pharmaceutical Clinical Research Co. Boca Raton, Florida

1997 to 2006

Regional Senior CRA/Pharmaceutical Consultant

Review clinical data to insure accuracy, completion and integrity of data.

Compare source documentation against case report forms.

Maintain a working knowledge and assure compliance with the GCP, ICH and

Sponsors SOP's.

Assure the supply and account for the disposition of clinical materials.

Report/disseminate all adverse reaction information in a timely manner as

defined by the Sponsor and the FDA.

Attend Investigator Meetings.

GCP and SOP training of site staff members.

Complete monitoring and other routine reports as required.

Qualify potential investigators.

Interact with investigators to obtain pre-study administrative packets.

Initiate investigational sites.

Conduct investigational site termination visits.

Serve as lead contact for the study team and clinical sites.

Present at the investigators meeting.

Conduct report review

PFDA Ltd.

Plainview, New York 1990 to 1997

Clinical Research Associate I & II

Monitoring of clinical investigative sites

Adherence to ICH guidelines and FDA regulations

Adherence to protocol guidelines

Case report form review

Source document verification

Drug and study supply accountability

Verification of regulatory documentation

Completion of monitoring reports

Facilitating communication between Sites and Sponsor

Resolving data communication with sites

Study close out visits

Pharmaceutical Food and Drugs Associates Roslyn, New York

1981 to1990

Clinical Research Associate I

Actively participated in study start-up process

Assisted with site selection

Conducted study qualification visits

Ensure integrity of clinical data against source documentation

Conducted site visit reports

Ensured drug and site material accountability

Reviewed and maintained regulatory documentation

Investigated any queries between site and the sponsor

Conducted site close out visit

Therapeutic Areas

Gastroenterology: Ulcers, Diabetic Stasis, GERD, IPPUAD

Anti-Infective: UTI, URI, Otitis Media, Post-Surgical, Sepsis

Pain Management: Migraine, Post Dental Extraction Pain. Post Operative

Pain, Dysmenorrhrea

Endocrine: Obesity, Diabetes

Cardiovascular: Hypertension, Congestive Heart Failure, and

Hypercholesterolemia

Respiratory: Asthma, Chronic Obstructive Pulmonary Disease

Psychiatry: Social Phobia, GAD, and Obsessive-Compulsive Disorder

Dermatology: Psoriasis

Oncology: Pediatric Oncology, Melanoma, Anti-Emetic and Small

Intestines/Colon Cancer, Lung, Prostate, Breast

CLINICAL EXPERIENCE

(WY-4036)

To determine the efficacy of (XXX) in the relief of signs and symptoms of

anxiety associated with cardiovascular disease or associated with

cardiovascular symptoms in the absence of demonstrable organic disease.

(WY-4036) Short- term Double Blind

To determine the clinical efficacy, safety, and patients acceptance of

(XXX) in the symptomatic treatment of psychoneurotic patients displaying

symptoms of anxiety of at least a moderate degree with or without

accompanying somatization or depression

(XXX)/VALIUM

To compare the efficacy of (XXX) and Valium (Diazepam) in patients in a

family practice setting who exhibit manifestations of psychoneurotic

anxiety and depressive disorders

.

XXX/YYYY

The study will compare anxiolytic and anti-depressant effects of (XXX) with

those of a (YYYY) plus (XXXX) combination drug in treating patients with a

diagnosis of mixed depression and anxiety in association with subjective

gastrointestinal complaints.

To evaluate the effect of (XXXX) on anxiety associated with organic disease

or the normal reactive anxiety seen in office practice. (50 patients)

The evaluation of (XXXX) compared to (YYYY) and a placebo in the treatment

of symptoms of nervous tension associated with the Menopausal Syndrome. (96

patients)

The evaluation of (XXXX) tablets compared to (YYYY) and of placebo in the

treatment of anxiety tension states due to exaggerated autonomic response.

(25 patients)

VISTARIL VS PLACEBO

Oral Vistaril vs. Placebo on the induction and maintenance of sleep in

patients scheduled for surgery on the following morning.

(XXXX) STUDY (Short-term Double Blind)

To determine the clinical efficacy, and safety of (XXXX) in the symptomatic

treatment of psychoneurotic patients displaying symptoms of anxiety with or

without accompanying somatization (50 patients)

COUGH/COLD PREPERATIONS

I have been involved in a large variety of clinical trials assessing safety

and efficacy for expectorant, antitussive, antihistamine and decongestant

efficacy. Many of these studies were conducted during the Ethical to OTC

push which started in the mid-1980.

DECONGESTANTS

In the area of antihistamine and decongestant studies, I have been involved

in a variety of both objective and subjective analysis. In studying those

subjects with acute Rhino Virus and acute Allergic Rhinitis, I utilized the

Yalton peak nasal flow meter which measures which measures the amount of

air being drawn in through the nasal passages to assess the level of the

subject's congestion. I was also involved in the development and use of

Vick nasal Rhinometer in order to assess a quantified level of the

subject's congestion. In conjunction with the above objective methodology,

I utilized various ordinal rating systems and visual analogs to assess the

subject's degree of congestion as well as their degree of relief from the

product being tested. The following are some of the products I have done

research on:

Vicks Formula 44

Nyquil

Triaminic

Dimetapp

Tuss-Ornade

PULMUNARY

In the area of COPD, I recently completed an audit of a 40 site clinical

trial entitled:

A randomized, Double-Blind, Placebo-Controlled, Parallel Group, Stratified,

Multi-Center, 12-Week Stydt, Comparing the Safety and Efficacy of

Fluticason and Formoterol Combination (FlutiForm 100/10 ug twice daily) in

a Single Inhaler (SkyePharma HFA pMDI) with the Administration of Placebo

or Fluticasone (250 ug twice daily) and Formoterol (10 ug twice daily)

Alone in Adolescent and Adult Patients with Moderate to Severe Asthma

COUGH COUNTING STUDIES

During the period I worked for PFDA, I was involved in a large number of

cough counting studies for both acute and chronic cough conditions. The

study population consisted of both stable COPD subjects as well as Subjects

with acute rhino virus. I have conducted cough counting studies for the

following companies:

A.H. Robbins

Warner-Lambert

Richardson Vick

Proctor & Gamble

SKB/SKF

A Multicenter Double-blind Randomly allocated study of two proposed

formulations and commercial Dimetapp vs. Placebo in Pediatric patients 4

to 6 years of age with Rhinitis.

16 Centers (45 subjects per center)

GASTROENTEROLOGY

I have been involved in over 50 clinical trials in the GI area. The

following six protocols are an example of some of the GI work I have been

involved with:

A Double - Blind randomized placebo controlled crossover Acid

Reflux/G.E.R.D., 16 patients study utilizing the Oxford Medilog 5000 system

to assess reflux ph. 14-hour assessment

A.H. Robbins

A Double-Blind, placebo controlled crossover, comparison study for the

relief of symptoms of Gastric Distress; Heartburn, Acid Indigestion, Sour

Stomach and fullness/Bloating

60 patients 5 sessions (Warner-Lambert, Richardson Vick, Proctor & Gamble,

A.H. Robbins, Eaton Norwich, and Stuart Pharmaceutical)

Double-Blind two-way crossover Acid Reflux, 16 patients, 3-hour assessment

Del Avionics Nasal Catheter System

Treatment of Acute Duodenal Ulcer with an H2 - Receptor Antagonist or

Placebo 12 weeks, 3 Endoscopies confirmation. (4 centers 48 patients)

The safety and efficacy of Prostaglandin E1 on Duodenal Ulcer Disease; a

double blind, placebo-controlled study

Effect of Prostaglandin El on Duodenal Ulcer Recurrence; a double-blind,

placebo-controlled study following Prostaglandin El double-blind Ulcer

Healing study.

In the pat I have been involved in a variety of both Ethical and PTC G.I.

research. The following is a listing of the G.I. products I have worked on.

OTC PRODUCTS ETHICAL PRODUCTS

Alterna Gel Tagament

Mylanta Reglan

Mylanta II Tablets Rioprostal

Mylanta II vs. H2 Antagonist Domperidone

Rolaids Librax

Rolaids (Calcium Rich)

Rolaids (Sodium Free)

Tempo

Pepto Bismal

Donnagel

Donnagel Elixir

Donnagel Extentabs

Donnagel Tablets

Mitrolan Tablets

Senoket

Mylicon

I have extensive experience in monitoring the following types of G.I.

Clinical trials.

Provocative Meal Syndrome

Overindulgence (Food, Alcohol, or Combination)

Anti-Diarrheal

Overindulgence Prophyxlaxis

Gastric Stasis

Gamma Camera Analysis

Manometric Analysis

GERD

Gastric and Duodenal Ulcers

Endoscopic Analysis

Ambulatory P.H. studies

Chronic and Acute Constipation

Pediatric Colic

Adult Flatulence and Excessive Gas

Several of the areas of safety and efficacy testing that I have been

involved with are: Therapeutic Modalities in the treatment of Digestive

Tract Disease, including H-2 Antagonists, Anti- Cholinergic, Antacids,

Colloidal Bismuth, Bulk Laxative Agents, and Anti-Diarrheals.

The following is an example of some of the Anti-Diarrheals/ GI Upset

protocols I have been involved with:

A double-blind placebo controlled parallel design to evaluate the

effectiveness of a Bismuth Subsalicylate formulation in treating simple

diarrhea and other symptoms of non-specific GI upset. 100 patients.

A double-blind randomized placebo controlled crossover to evaluate the

efficacy of Bismuth Subsalicylate in alleviating the symptoms of

gastrointestinal distress attributed to excessive food/alcohol ingestion.

100 patients.

A double-blind randomized study to screen the anti-diarrheal effect 25 G

instantized pregelatinized starch taken in 4 consecutive doses (25 G. per

dose) at 12 hour intervals for diarrhea and to compare its effect with that

of Pepto Bismol taken at 60 ML every 12 hours for 4 consecutive doses.

A double-blind randomized placebo controlled crossover to evaluate the

efficacy of Bismuth Subsalicylate capsules versus placebo capsules in

alleviating the symptoms of gastrointestinal distress attributed to

excessive alcohol/food consumption.

A double-blind randomized placebo controlled parallel designed study to

screen the anti-diarrheal effect of 60 ML of Pepto Bismal taken every 12

hours for 4 consecutive doses versus a placebo. Proctor & Gamble, 30

patients

LAXATIVES

I have been involved in numerous clinical trials designed to asses both the

safety and efficacy of many different types of laxative products. The

following is a short list of some of the laxative studies I have been

involved with:

A randomized double-blind crossover study comparing the efficacy and safety

of (XXXX) Syrup to (YYYY) Syrup/placebo for the treatment of various types

of constipation occurring in a geriatric nursing home population. 70

subjects.

A single-blind parallel study design to determine the effects of two

dosages of a bulk laxative consisting of Refined Corn Bran (7 gms) and

Pysllium (3.5 gms). 90 subjects.

A double blind parallel study design to determine whether the normalization

of bowel function and/or improvement of abdominal pain referable to the

lower gastrointestinal tract for which no anatomic abnormality is

demonstrable differ between patients treated with Polycaarbophil Chewable

Tablets and those treated with placebo. 270 subjects.

An open label study to assess efficacy, safety, toleration, and acceptance

of Polycarbophil in patients with irritable bowel syndrome during long term

(6 month) use. 100 subjects.

ANTI-INFFECTIVES

A Double-Blind Study of the efficacy and safety of Floxacillin in the

treatment of skin and skin structure infections when compared to

Dicloxacillan. (4 sites, 96 subjects) Generic Group

Comparison of the Safety and Efficacy of (SCH 39720) with that of Cefaclor

in the treatment of acute Otitis Media in Children (5 sites, 100 subjects)

I have been involved in the study of anti-infectives for the treatment of

URI, LRI, UTI, Pneumonia, and Post-Surgical Infection.

A multicenter open-label non-comparative study of Parenteral (XXXX) in the

treatment of hospitalized pediatric patients with infections caused by

susceptible bacteria. (10 center, 40 subjects per center)

A study to determine the pharmacokinetics, safety, and efficacy to (XXXX)

in the treatment of infections where Pseudomonas Aeruginose is a clinically

significant pathogen (patients 2 to 15 years), 4 centers (enrollment open)

A comparative study of two doses of A-46811, with Amino glycosides in

patients with urinary tract infections due to Pseudomonas Aeruginosa.

(Comparative Aminoglycoies- Amikacin Sulfate, (YYYY).

Phase II. 8 centers (50 subjects per center)

Comparative safety and efficacy of A-49759 (ODMF) in patients with urinary

tract infections- Phase II 8 centers, (35 subjects per center)

Comparative safety and efficacy of A-49759 (ODMF) and (XXXX) in patients

with lower respiratory tract infections- Phase II

8 centers (35 subjects per center)

A multicenter open, non-comparative study of Parenteral (XXXX)

(cephalosporin) in the treatment of hospitalized patients with infections

caused by susceptible bacteria.

Phase III, 15 centers, (30 subjects per center)

A multicenter, observer blind, comparative study of Oral Ru 965 and

Erythromycin Ethylsuccinate (EES) in patients with infections caused by

susceptible bacteria- Phase II.

18 centers, (30 subjects per center)

A double-blind study of the efficacy and safety of B-1105 in the treatment

of skin structure infections when compared to (YYYY) 10 centers (20

subjects per center)

Comparison of the efficacy and safety of SCH 39720, with that of Cefaclor

in the treatment of Acute Otitus Media in children 2 to 12 years of age 2

centers (48 subjects)

VITAMIN RESEARCH

Prenatal Program

Placebo controlled comparative trial of various Prenatal Formulations. A

six hour bio-availability study. (30 subjects) Tulane University

A placebo controlled comparative trial of various Prenatal formulations in

pregnant women:

To compare the amount of iron absorbed into the bloodstream following the

administration of single doses of four commercially available prenatal

formulations and placebo in women in the second or third trimester of

pregnancy. Tulane Medical Center

The availability of Iron from several prenatal multi-vitamins /mineral

formulations: a comparison

Underfed vs. Fasted conditions in pregnant women in their second and third

trimester

(40 subjects) University of Texas Galveston

A controlled multicenter comparative trial of various prenatal supplements

containing Iron:

To evaluate and compare patient's acceptance and adverse experiences

related to daily ingestion of various prenatal vitamins/mineral supplements

for 8 weeks. 3 sites (private physicians, 240 subjects)

A clinical trial of reformulated commercially available product: A

prenatal nutritional supplement of vitamins and requiring one tablet daily:

entered prior to or at 28 weeks of pregnancy. Private Physician (40

subjects)

A single-blind controlled comparative trial of various iron supplement

formulations: to compare the level of gastrointestinal and related

disturbances of two commercially available prenatal formulations with iron.

(300 subjects). University of South Carolina

ANALGESICS

A double - blind multicenter Aspirin controlled 12 week study to determine

the efficacy and safety of (NSAID X) in patients with Rheumatoid Arthritis.

(5 center, 125 subject)

Single -blind evaluation of the analgesic effect and safety of XXXX in the

treatment of patients with chronic pain (3 centers, 150 subjects)

Double -blind evaluation of the analgesic effect and safety of XXXX in

patients with muscle contraction (or tension) headaches.

(100 subjects, 2 sites)

An open- label study to determine the safe and effective dosage of XXXX in

patients with chronic degenerative disease (Osteoarthritis) of the knee or

hip joint

(1 site, 30 subjects)

Double-blind evaluation of the analgesic effect of YYYY in patients with

post-meniscectomy pain (3 site, 90 subjects)

A double blind multicenter study to compare the efficacy and safety of XXXX

against placebo in the treatment of patients with primary dysmenorrhea (2

sites, 100 subjects)

Evaluation of the analgesic effect of XXXX in patients with postpartum

uterine cramp or post episiotomy pain (3 site, 120 subjects)

A double-blind evaluation of the analgesic effects of (NSAID X) in patients

with pain following oral surgery. Third and Fourth molar extraction (2

site, 90 subjects)

To evaluate the safety and efficacy of (NSAID Q) in comparison with aspirin

and placebo in patients with post- partum uterine cramps (2 site 60

subjects)

To evaluate the safety and efficacy of (NSAID K), 250,375, and 500 mgs in

subjects with acute

episodes of rheumatoid arthritis. (3 site, 90 subject)

To evaluate the safety and efficacy of (NSAID K) 250, 375, and 500 mgs in

subjects with acute episodes of osteoarthritis (3 site, 90 subjects)

Assessment of the efficacy and safety of single oral doses of A-10281 in

the treatment of post dental extraction pain

(2 site, 100 subjects)

Preliminary protocol for developing and standardizing a low back pain model

for use in studying the efficacy of a muscle / relaxant analgesic

combination agent (1 site, 20 subjects)

A double blind preliminary study to assess the safety and toleration of

XXXX administered as a 100mg single oral dose to healthy volunteers. (1

site, 15 subjects)

A double blind preliminary group study to assess the efficacy and safety of

various doses of AAAA in the relief of post - cesarean section pain. (160

subjects, University South Carolina)

CARDIOVASCULAR

A Multinational, Multicenter, Open-Label, Comparison of Intravenous, "XXXX

Versus Sodium Nitroprusside In Patients With Severe Hypertension. Protocol

82526/D1101/WW

ANTIHYPERTENSIVES

A comparison of the efficacy of XXXX and YYYY in the treatment of

hypertension and hypertensive cardiovascular disease of the mild to

moderate variety (30 patients)

A multicenter comparison of XXXX and YYYY/XXXX combination to evaluate the

safety of XXXX (2 mg/0.5 mg) as a fixed combination vs. YYYY (0.5 mg) alone

in the treatment of essential hypertension (24 patients.)

A comparison of the efficacy of XXXX with the YYYY in the treatment of

hypertension and/or hypertensive cardiovascular disease of mild to moderate

severity 16 week trial (30 patients)

A comparison of the efficacy of XXXX with that of Renese-R (polythiazide

plus reserpine) in lowering blood pressure in patients with diagnosed

hypertension. 16-week trial. (50 patients) 4-week placebo washout

A multicenter comparison of XXXX and YYYY polythiazide combination to

evaluate the safety and efficacy of (2 mg/0.5) as a fixed combination vs.

XXXX/YYYY (0.5 mg) alone in the treatment of essential hypertension (50

patients)

A comparison study of XXXX vs. YYYY in hypertension to compare the efficacy

of XXXX with that of YYYY in the treatment of essential hypertension An

open, randomized crossover evaluation (50 patients)

A collaborative comparison evaluation of the side effects profile of XXXX 2

mg and YYYY 1 mg given b.i.d. with 25, in patients with essential

hypertension 15 investigators (200 patients)

A double blind randomized study to evaluate the effects of Long-Term

Antihypertensive Therapy on Plasma Lipids and Lipoproteins and Quality of

Life (AHR-4458) (10 investigators, 210 patients).

A Multinational, Multicenter, Open-Label, Comparison of Intravenous, "XXXX

Versus YYYY in Patients with severe hypertension. 150 subjects

CONGESTIVE HEART FAILURE

A 12 week double blind, placebo controlled study to determine the efficacy

and safety of orally administered (CI-906) HCL in the treatment of

congestive heart failure (5 investigators, 50 patients).

An open label 12-month period treatment with oral XXXX for the treatment of

congestive heart failure 5 investigators, 50 patients

ANGINA PECTORIS

A four week double-blind, placebo controlled multicenter study to determine

the efficacy and safety of twice-a-day orally administered (CI-775) dosing

regiment in patients with Angina Pectoris undergoing exercise tolerance

testing. 8 investigators, 92 subjects.

Efficacy and Safety of Core-Coat (Bay k5552) 10, 20, and 30, mg QD Vs.

Placebo in Patients with Stable Exertional Angina Pectoris. 2

investigators, 32 subjects

ENDOCRONOLOGY

Diabetes Type II

A. LAF237A231190- A multi-center, randomized, open-label, active

controlled, parallel arm study to compare the efficacy of 12 weeks of

treatment with Vildagliptin 100 mg, qd, to thiazolidinedione (TZD) as add-

on therapy in patients with Type II diabetes inadequately controlled with

metformin monothereapy in a community-based practice setting.

600 centers, 12,000 patients-National Study (November 15, 2006- January 1,

2008)

I3 Research, Regional CRA, Florida and Puerto Rico

Oncology

Solid Mass Tumor Phase II and III

Phase II Trial to Compare the Effectiveness of XXX to Tamoxifen For

Prevention Of Breast Caner Recurrence In Post-Menopausal Women With Ductal

Carcinoma In SITU (DCIS) of The Breast.

Leukemia

Myeoblastic Leukemia Phase IIA and IIB

Carcinoma of the Prostate Phase IIIA

Solid Pseudopapillary Tumor of the Pancreas

A Randomized Placebo Controlled Study of XXXX Plus XXXX In Patients With

Locally Advanced, Unrestrictable Or Metastatic Pancreatic Cancer

Phase III Trial Comparing Four Regimens Of Chemotherapy For First-Line

Treatment of Advanced or Metastatic Pancreatic Adenocarcinoma

EDUCATION

Adelphi University

May 1985

M.A. -Sociology

Teaching Associate

Institute for Applied Pharmaceutical Sciences 1982

East Brunswick, New Jersey

Tulane University

May 1981

New Orleans, La.

B.A.-Sociology/Political Science

Dual Degree Awarded

Deans List

CONTINUING EDUCATION

The following courses were reviewed and tested on during 2006-2008:

Introduction to SOP Training

An Introduction to Six Sigma

eClinical 7.5 Module 1 Course1-Introduction

eClinical 7.5 Module 1 Course 2-Navigation

eClinical 7.5 Module 5 Course 4-Monitoring Visits

eClinical 7.5 Module 5 Course 5 Course- Monitoring Visit Report Tracking

eClinical 7.5 Module 8 Course 1-Reports

Electronic Records and Signatures

Field Monitoring Orientation

Fraud and Misconduct SOP Training

Introduction to Siebel Clinical for CRA'S

Selection of Investigative Sites

Pre-Study Site Visit

Monitoring Visit

Source Data Verification

New Employee Orientation

Essential Documents 1

Essential Documents 2

Essential Documents 3

Informed Consent Development

Trial Master File Consent and Management

Distribution of Signatures for Clinical Study Personnel

Clinical Trial Safety Surveillance: Serious Adverse Processing 1

Clinical Trial Safety Surveillance: Serious Adverse Processing 2

Source Data Verification Process

Time Tracking for CRA'S

Investigational Product Relabeling at site

Central Files

Ethics and Integrity Program Overview

Handling Sensitive Data and Electronic Media

Work Lesson 1- Ethics and Integrity Overview

Work Lesson 2-Privacy Overview

Work Lesson 3-Protecting Company Intellectual Property

Work Lesson 4-Records Management Awareness

Work Lesson 7- Information Security

Work Lesson 8- Conflicts of Interest

Work Lesson 9- Foreign Corrupt Practices Act (FCPA)

Harassment Prevention Training for Employees

Ingenix Privacy Policy Overview

LearnWell Training for Employees

Distribution, Maintenance and Handling of SOP'S

Documentation of Signatures for Clinical Study Personnel

Retention of Records Relating to Clinical Projects

Documentation Practices

Telephone Communications with non-i3 personnel

Vendor Qualification

Vendor Identification and Review for Qualification

Business Continuity

Potential Fraud and Misconduct (For-Cause) Investigations

Inspection by Regulatory Agencies 1

Inspection by Regulatory Agencies 2

Training and Development 1

Training and Development 2

Processing Contract or Work Order Changes

Compliance with 21 CFR Part 11-1

Compliance with 21 CFR Part 11-2

Audits by i3 by Sponsors

Corrective and Preventive Action Quality Process

Physical and Logical System Security 1

Physical and Logical System Security 2

Informed Consent Preparation

Investigator Site Audits

Filling and Archiving of Quality Assurance Audits 1

Filling and Archiving of Quality Assurance Audits 2

Reporting and Distribution of Quality Assurance Audits

Ingenix Quality Assurance Policy

Quality Assurance Policy

Global Pharmacovigilance Policy

Right the First Time and Quality Program

Siebel eClinical Version 7.8 Upgrade- Module 1

Siebel eClinical Version 7.8 Upgrade- Module 2

Selection of Investigative Sites

Site Initiation Visit

Close-Out Visit

Source Data Verification

Case Report Form Retrieval and Transmittal 1

Case Report Form Retrieval and Transmittal 2

Investigational Product Accountability

Selection of an Investigation Product Storage and Shipment Family

Selection of Central Laboratory

Selection of Central Institution Review Board

Selection of Central Institution Review Board or Ethics Committee

Financial Disclosure Policy 1

Financial Disclosure Policy 2

Translation of Essential Documents

Translation of Essential Documents

Operations Manual

Computer System Validation Committee (CSVC)

Data Lock and Freeze

Serious Adverse Event Reconciliation 1

Serious Adverse Event Reconciliation 2

Format, Creation, Revision and Approval of SOP's

eClinical 7.5 Instructions for Training

GCP Series Module 1: Introduction to Good Clinical Practices

GCP Series Module 3: Informed Consent

GCP Series Module 4: Drug Safety

GCP Series Module 5: Ethical Review Boards

GCP Series Module 6: Financial Disclosure

Generating Reports in Ellipsis Time Tracking

Global Master File and Transmittal Form Attachments

In the Company of Specialists: The New Employee Orientation Program

Policy on progress Documentation

i3 Quality Policy

Monitoring Visit

Selection of an Investigational Product Storage and Shipment Facility

Selection of a Central Laboratory

Audits of i3 by Sponsors

Computer Skills

Microsoft Windows XP, Word, Word perfect, various EDC systems such as

Inform, among others.

Contact this candidate