Genice Jacques Resume Page 1

GENICE JACQUES 19419 Dawson street Lytle Tx 78052 genicej85@gmail.com (512)317-5916

Education_______________________________________________________

CERTIFIED CLINICAL RESEARCH COORDINATOR-ACRP WRITTEN EXAM SEP 2013

FRED PRYOR SEMINAR/CAREER TRACK/ PROFESSIONAL EDUCATION AUG 2013 MAKING THE TRANSITION FROM STAFF TO SUPERVISOR-FRED PRYOR

*PRIORITIES OF A NEW SUPERVISOR

*GAINED THE SKILLS YOU NEED TO PUT YOU IN LINE FOR GREATER REWARDS AT WORK: POSITIVE RECOGNITION, INCREASED JOB SATISFACTION, AND BETTER BENEFITS

FRED PRYOR SEMINAR/CAREER TRACK/ PROFESSIONAL EDUCATION SEP 2013 DEALING WITH DIFFICULT PEOPLE-

* BEHAVIORS THAT DESCRIBE PEOPLE * FOUR GOALS FOR BETTER COMMUNICATION

* FOUR PRINCIPLES OF EFFECTIVE COMMUNICATION * CHOICES WHEN DEALING WITH PEOPLE

CAREER POINT COLLAGE-SAN ANTONIO TX 2006

Medical Office Specialist/Phlebotomy

Curriculum included but not limited to:

Phlebotomy I and II- training in proper blood collection techniques and skills.

Proper usage of laboratory equipment and techniques

Medical terminology and anatomy

EKG capturing and monitoring

Law and Ethics

Insurance coding and Billing

Excel and Microsoft works

6week clinical externship with family practice ( hired on full time prior to completion)

BANDERA HIGH SCHOOL-BANDERA TX 2000-2004

Basic High School curriculum,

Professional Experience_____________________________________________ The Geneva Foundation 20 Apr 2015 to Present

Assist in study selection Recruitment Pre-selection and Primary screening, enrollment and maintenance visits overseeing and assessment obtaining contact for Sponsor and Study Monitor for all types of visit ( PSSV,PSIV, SIV, Routine, and Closeout) Site representative for Investigator meetings, Community outreach events and varies programs Supply ordering and inventory IRB and safety reporting Regulator assistance Sponsor outlined visit assessments Quality review of active an closing studies Maintain up to date ICH/GCP AND Biomedical training for all PI and Sub I Program supervisor and trainer for research assistance transiting to study coordinator Quality assurance/ In-house monitoring for PI imitated studies

TTS RESEARCH-26 June 2009 to 17 Apr 2015 Certified Clinical Research Coordinator (CCRC)/ Clinical Team Lead (CTL)

Assist in study selection, site feasibility, negotiation and budget Recruitment Pre-selection and Primary screening, enrollment and maintenance visits overseeing and assessment obtaining Obtaining participants informed consent contact for Sponsor and Study Monitor for all types of visit ( PSSV,PSIV, SIV, Routine, and Closeout) Site representative for Investigator meetings, Community outreach events and varies programs Supply ordering and inventory IRB and safety reporting Regulator assistance Budgeting assistance

Genice Jacques Resume Page 2

Maintain work follow and oversee study conduction for research coordinators Monitor accuracy of lab tech and pharmacy tech and record pharmacy Visit test and procedures scheduling ECG/EKG collection and monitoring Lab draws adult and pediatric

o *routine *serial PK *Specific panels *RNA * Biomarkers Process Labs/package and shipment of specimens Scheduling test and procedures

Laboratory specialty and unique skills: Erythrocyte sedimentation rate (ESR) Sputum induction Sputum processing for cultures Sputum processing for cell count Cytology processing Inventory sites supplies office use/ lab use/ and study specific equipment use. Collecting research data, entering electronic data in varies data bases. Ensure accuracy in documentation Investigational Product management

*Receipt *Storage and handling *Dispensing and training *Accountable

Managing the use of investigational and sponsor provided devices 24 hour holter monitors, 24 hour serial Spirometry, 24 hour blood pressure cuffs, 24 hour urine collection, Electronic dairy’s and peek flow meters. Master Scopes with single and multi protocol and Flow Screen Spirometry per dose, post dose, performance of serial including 12 and 24 hour Spirometry with protocol defined time points. Train and re-education to Maintain compliance with e-Dairies/paper and study equipment Train study specific procedures to other coordinators and delegated staff members provide professional advice and support to other team members Insure that team members are adhering protocol specifications follow GCP guidelines Next day preparation insurance

o Verifying chart quality and readiness o Equipment set up and prepared including any lab sampling needed o Check key data for continuation with next visit.

Please note that these task and duties are mainly of the daily work, and some special skills. I am not limited to these and am equipped In many other skills and willing to learn new things.

While working with TTS Research I have had direct involvement in the growth and awareness of our company which is awarding in its self. Including a helpful hand in the creation of the facilities mission statement, Company’s goals and commitment message. I have also helped connect us with surrounding community business and maintained positive work relations with them. I have had an active involvement as Lead coordinator role in over 39 clinical trials, holding the role of back up coordinator in over 25 trials. Worked in therapeutic area of Asthma (persistent to uncontrolled) adult and pediatric, Allergies for adults and pediatric. COPD Gold 3 and 4. Diabetes type 2 adult and pediatric, and Hypertension acute pain management. Please see my curriculum vitae for the different trails ranging from devise studies to biological.

Pinkston Family Practice Feb 2005-Aug 2005 Medical Office Specialist

Job entailed some of the following but not limited to: visit scheduling billing and coding/ pre authorization Prescription call in and refills authorizing under Physicians approval Patient intake and triaging Vital collection Obtain ECG/EKG Prepare and Assist Physician with procedures Vaccinations administration and accountability Filing charting Room cleaning and stocking sterilize of equipment and supplies

All business/professional references are available upon request. Thank you for your time and consideration.

Genice Jacques Resume Page 3

Genice Jacques Curriculum Vitae

601 Walnut Way Boerne TX 78006 genicej85@gmail.com (512)317-5916

Professional Experience_______________________________________ Certified Clinical Research Coordinator (CCRC)/ Clinical Team Lead

GCP Training: current Collaborative Institutional Training Initiative (CITI), Office of Human Research Protection (OHRP), ICH/GCP

(E-6) – Sections 1-8 – Self-Study, PHRP through NIH.

CITI Biomedical Research/ Human research: current

IATA Certificate of training: current

Classification/Identifying per [Title 49 of the Code of Federal Regulations, Section 172.101.]

Packaging Section 178 of CFR 49.

Labeling Section 172.400 and 172. 101 of CFR 49.

Over 6 years of as a full-time study coordinator – therapeutic involvement predominantly in the area of respiratory: COPD, asthma,

allergy and immunology. Therapeutic trial phase of involvement are Phases IIa, to IV, open label and Device studies. Doing Oral,

Inhalation, intranasal, IV, Sub-Q, transdermal-patches Please note that the below list is not all studies I have been delegated roles for of responsibility and participation, but a details of

studies participation which I have had active involvement as a Lead study coordinator , along with the duration of involvement.

Study Participation Oncology Phase 2 Study of Poziotinib in Patients with HER2-Positive Metastatic Breast Cancer (MBC) Who Have Received Prior

HER2 Regimens for MBC Involvement from May 2016 to present *Role Study Coordinator

Pulmonology & Immunology COPD XXX A 12-week Phase II Study to Evaluate the Efficacy and Safety of XXX Following Exacerbations in Patients with Chronic

Obstructive Pulmonary Disease (COPD) by Targeting the SHIP1 Pathway.

Involvement from Oct 2014 to present *Role Study Coordinator

A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort®

pMDI 160/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in COPD

Patients. This XXX study – Revealing the Impact of Symbicort in reducing Exacerbations in COPD Involvement from Sep

2014 to present *Role Lead Study Coordinator

A randomized, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily

treatment of two doses of orally inhaled XXX + XXX fixed dose combination (delivered by the Respimat inhaler... Involvement from Jan 2014 to present *Role Lead Study Coordinator A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-

Center Study to Assess the Efficacy and Safety of XXX, XXX, and XXX in Subjects With Moderate to Very Severe COPD, Compared With Placebo ... Involvement from Aug2013-Present *Role Lead Study Coordinator A multi-center, randomized, double-blind, 52-week study to assess the safety of XXX compared to XXX in patients with Chronic Obstructive Pulmonary Disease (COPD) who have moderate to severe airflow limitation Involvement from Nov2013- Present *Role Lead Study Coordinator A 12-week treatment, multi-center, randomized, doubleblind, parallel-group, placebo and active controlled study

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to assess the efficacy, safety, and tolerability of XXX (indacaterol maleate / glycopyrronium bromide) in COPD patients with moderate to severe airflow limitation. Involvement from May2013- Present *Role Lead Study Coordinator

A randomised, double-blind, chronic dosing (56 week) placebocontrolled, parallel group, multicentre, phase III study to evaluate the

efficacy and safety of 2 doses of benralizumab (XXX) in patients with moderate to very severe Chronic Obstructive Pulmonary

Disease (COPD) with a history of COPD exacerbations Involvement from

May 2014- Present *Role Lead Study Coordinator

A randomized, double blind, parallel group study to assess the efficacy and safety of 12 weeks of once daily, orally inhaled, co-

administration of XXX (delivered by the Respimat® Inhaler) and XXX (delivered by the HandiHaler®) compared to once daily,

orally inhaled, co-administration of placebo (delivered by the Respimat® Inhaler) and XXX (delivered by the HandiHaler®) in

patients with Chronic Obstructive Pulmonary Disease (COPD) [ANHELTO™1] [ANHELTO™2] Involvement from Oct2012-Oct 2013 *Role Lead Study Coordinator A Phase III, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed

Dose Combinations XXX Compared With Aclidinium XXX and Placebo for 24- Weeks Treatment in Patients With Moderate to

Severe, Stable Chronic Obstructive Pulmonary Disease (COPD) Involvement from Oct 2011- Oct2012 *Role Lead Study Coordinator A Phase III, Long-Term, Randomized, Double-Blind, Extension Study of the Efficacy, Safety and Tolerability of Two Fixed Dose

Combinations of XXX and Placebo for 28-Weeks Treatment in Patients with Moderate to Severe, Stable Chronic Obstructive

Pulmonary Disease (COPD) Involvement from Jan 2012-Jan2013 *Role Lead Study Coordinator

A 52-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of XXX on Exacerbation

Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS) Involvement from Jan2012-Present *Role Lead Study Coordinator A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of XXX in Chronic Obstructive Pulmonary Disease Involvement from Jan2012-March2014 *Role Lead Study Coordinator A Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of XXX in Subjects with Moderate-to-severe Chronic

Obstructive Pulmonary Disease and Sputum Eosinophilia . Involvement from May2011- March2014 *Role Lead Study Coordinator A Clinical Outcomes Study to compare the effect of Fluticasone XXX on Survival in Subjects with moderate Chronic Obstructive

Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease. Involvement from June 2011-Present *Role Lead Study Coordinator A 52-week efficacy and safety study to compare the effect of three dosage strengths of XXX on the Annual Rate of Exacerbations in

Subjects with Chronic Obstructive Pulmonary Disease (COPD) Involvement from Jul 2009-Dec2011 *Role Lead Study Coordinator A 24-Week Study to Evaluate the Efficacy and Safety XXX Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Compared with Placebo in Subjects with

Chronic Obstructive Pulmonary Disease (COPD) Involvement from Oct2009-July2011 *Role Lead Study Coordinator Asthma

A Pahse 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy and Safety Of A Human Monoclonal

Antibody, REGN2222, for the prevention of medically attended RSV Infection In Preterm infants

JUN 2016 to presant *Role Study Coordinator A Multicentre, Randomized, Double-blind, Parallel Group, Placebo controlled, Phase III Efficacy and Safety Study of XXX Added

to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients with Uncontrolled Asthma (XXX) .. nvolvement from Feb 2015 to April 2016 *Role Lead Study Coordinator

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A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Bioequivalent, Dose ranging Study of XXX in

Adult Subjects with Persistent Asthma Involvement from Oct 2014- April 2016 *Role Lead Study Coordinator

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo controlled, Phase III Efficacy and Safety Study of XXX Added

to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist i A phase III, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of XXX in the patients with

uncontrolled asthma who are on inhaled corticosteroids and a second controller medication. Involvement from Jan 2014 to April 2016 *Role Study Coordinator A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose-Ranging Study of XXX in

Adult Subjects with Persistent Asthma Involvement from Aug2013-Present *Role Lead Study Coordinator A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of XXX in the Reduction

of Clinical Asthma Exacerbations and Change in Lung Function in Patients (12-75 Years of Age) With Eosinophilic Asthma Phase 3

Involvement from July2011-March 2014 *Role pharmacists / Investigational Products An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of XXX as Treatment for Patients With

Eosinophilic Asthma Who Completed a Prior Teva-Sponsored Study Eosinophilic Asthma Phase 3. Involvement from Jul 2012 to April 2016 **Role pharmacists / Investigational Products A Safety, Efficacy, and Tolerability Study of Daily Dosing with XXX and Placebo in Subjects Aged Birth to <48 Months with

Asthma Involvement from Mar2010-Oct2013 **Role Lead Study Coordinator A randomized, double blind, active controlled ,Phase 3 extension study investigating the safety and efficacy over 40weeks of 2 dose

of XXX in asthmatic infants and children (aged 12 months to 8 years at enrollment into XXX study). Involvement from Jun2009-2009*Role Lead Study Coordinator A Randomized, Double-Blind, Parallel Group study of XXX and XXX, both twice daily, in a Pediatric Population during the Fall

Viral Season. Involvement from Jul2010-Dec2010*Role Lead Study Coordinator A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose study to evaluate the Efficacy and Safety of

Intravenous XXX in Patients with Severe Asthma. Involvement from Aug09-Sep2010 *Role Lead Study Coordinator A multi-center, randomized, double-blind, placebo-controlled, five period cross-over study to evaluate the efficacy and safety of

selected doses and dose intervals of XXX administered via a novel dry powder inhaler (NDPI) in subjects ≥18 years of age with

persistent asthma Involvement from Jul2009-Jan2010 *Role Lead Study Coordinator Allergies A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen

Immunotherapy Tablet (XXX) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis

With or Without Asthma (Protocol XXX ). Adolesent and Adult Involvement from Jan2014 to April 2016 *Role Lead Study Coordinator Randomized Trial of the Safety of XXX Nasal Spray and XXX Nasal Spray in Children Ages >6 months to <6 years with Allergic

Rhinitis Involvement from Jan2014 to April 2016 *Role Lead Study Coordinator Evaluation of Hypoallergenicity of a 100% Whey, Extensively Hydrolyzed Infant Formula Involvement from Oct2010-2012*Role Lead Study Coordinator A 12-week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of XXX Nasal Aerosol in

Subjects 6 to 11 Years with perennial Allergic Rhinitis Involvement from Nov 2011 – Dec2012 *Role Lead Study Coordinator

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A 12-week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of XXX Nasal Aerosol in

Subjects 6 to 11 Years With Seasonal Allergic Rhinitis Involvement from Dec 2011 – Dec2012 *Role Lead Study Coordinator A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Once Daily XXX Nasal Aerosol

(XXX) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older Involvement from Oct2009 –Jan2011 *Role Lead Study Coordinator A 6-Month Open-Label, Long-Term Safety Extension Study of Once Daily XXX Nasal Aerosol (XXX) in The Treatment of

Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older Involvement from Jan2010-2011*Role Lead Study Coordinator

Cardiovascular & Endocrinology Hypertension A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Safety and Efficacy of

XXX in the Treatment of Acute Migraine in Patients With Stable Vascular Disease 1 Involvement from 2009-2010*Role Lead Study Coordinator Dyslipidemia A Randomized, Placebo and Ezetimibe Controlled, Dose-ranging Study to Evaluate Tolerability and Efficacy of XXX on LDL-C in

Hypercholesterolemic Subjects With a 10 Year Framingham Risk Score of 10% or Less

A Phase 3, Double-Blind, Double-Dummy, Randomized, Placebo and Active Controlled, Parallel-Group Study to Assess the

Efficacy, Safety and Tolerability of PF-04950615 in Subjects With Dyslipidemia Who Are Intolerant to Statins

Involvement from Apr2015– Dec2015 *Role Study Coordinator

Congestive Heart Failure

A multicenter, randomized, double-blind, placebocontrolled phase IIIb study to evaluate the efficacy, safety and tolerability of

Serelaxin when added to standard therapy in acute heart failure patients

Involvement from Apr2015– present *Role Lead Study Coordinator

A Multicenter, Randomized, Double-Blind, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of LCZ696

Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction

Involvement from Apr2015 – present *Role Lead Study Coordinator

A multicenter, randomized, double-blind, double dummy, parallel group, active-controlled 8-week study to evaluate the effect of

sacubitril and valsartan (LCZ696) versus enalapril on changes in NT-proBNP and safety and tolerability of in-hospital initiation of

LCZ696 compared to enalapril in HFrEF patients who have been stabilized following hospitalization for acute decompensated heart

failure (ADHF). Authors:

Involvement from Apr2016 – present *Role Lead Study Coordinator

Observational Registry of Treatment Patterns in U.S. Heart Failure Patients with Reduced Ejection Fraction

Involvement from Apr2016 – present *Role Lead Study Coordinator

Acute coronary syndrome A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel- group, Multicenter Study to Compare the Safety of

Rivaroxaban versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects with Acute Coronary

Syndrome (GEMINIACS1)

Involvement from Sept 2015 – present *Role Lead Study Coordinator

An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist

and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary

Intervention

Involvement from Oct 2015 – present *Role Lead Study Coordinator

Diabetes A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of XXX in

Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control Involvement from Nov2010-2012 *Role Lead Study Coordinator XXX to Evaluate the Safety and Efficacy of XXX Compared With XXX in Elderly Patients with Type 2 Diabetes Mellitus with

Inadequate Glycemic Control Involvement from Dec2011-2014

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A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor twice daily on the

Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus

Involvement from Apr2015- present *Role Lead Study Coordinator

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Cardiovascular Outcomes Following Treatment

with Ertugliflozin (XXXX) in Subjects with Type 2 Diabetes Mellitus and Established Vascular Disease

Involvement from Apr2015- present *Role Lead Study Coordinator

Pain management Acute pain

XXX, A Phase III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XXX,

Compared with Placebo for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.

Involvement from Jan 2014 to April 2016 *Role Lead Study Coordinator