Engracia C. Ramirez has over 15 years of experience as a clinical research coordinator and regulatory administrator. She currently works at Amun Medical Research and Horizon Research Group in Coral Gables, Florida. Her background includes coordinating numerous clinical trials in various therapeutic areas and ensuring studies are conducted according to regulations. Ramirez aims to work as an effective team member with integrity, trust, and respect to achieve goals and deliver excellence.

1. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
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CURRICULUM VITAE
Engracia C. Ramirez, CCRC
I like to work as a team member with integrity, trust and respect to achieve
our goals, obtain good results and deliver excellence in what I do for me to
be successful. I embrace these values, as the norther start to guide me and to
help me complete my service.
Present Position: Certified Clinical Research Coordinator/Regulatory Administrator Business
Development
Amun Medical Research
760 Ponce De Leon,Suite 113
Coral Gables, FL 33134
August 2015 – Present
Horizon Research Group
747 Ponce De Leon,Suite 605
Coral Gables, FL 33134
August 2015 – Present
Education:
Florida National College
Certified Phlebotomist/ EKG Technician
2006/2007 Miami, FL
Florida National College Miami, FL
2006/2007
Certified Nurse Assistant
Pureza De Maria High School
1983– 1987 Managua, Nicaragua
High School Diploma

2. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
__________________________________________________________________________________________
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Curriculum Vitae
Engracia C. Ramirez
Page 2, Revised 8/16
Professional Experience:
Certified Clinical Research Coordinator/Regulatory Specialist
Medispect Medical Research
400 Shadowline Dr,
Boone, NC 28607
January 2011– August 2014
Meeting requirements/expectations set forth by sponsor, review protocol and
data entry requirements with study team prior to study commencement,
actively manage workflow to ensure objectives are achieved, communicate
with sponsor representatives to effectively address any discrepancies that
may arise during the trial, and assist Quality Assurance department in
identifying potential issues during the conduct of a clinical trial clinical trial,
eCRF completion, query resolution, discuss protocol and data entry
requirements with study coordinator prior to study commencement, actively
manage workflow to ensure data entry objectives are achieved, communicate
with research coordinator and sponsor representatives to effectively address
any discrepancies that may arise during the trial, assist Quality Assurance
department in identifying potential issues during the conduct of a clinical
trial.
Certified Senior Research Coordinator- Regulatory Compliance
Miami Research Associates (Phase I- II-IV)
6280 Sunset Drive, Suite 604
Miami, FL 33143
2008/2011
Manage all day-to-day activities necessary to facilitate the successful
completion of each trial. Develop and executed plan to ensure that all aspects
of each study were completed with strict adherence to the protocols.
Evaluated and analyzed clinical research data to ensure accuracy and
consistency between source paper documents. Timely reported of critical
study events. Assisted in the preparation of Review Board and FDA audits.
Responsible for identifying clinical protocols and implementing them as
project lead. Assisted in accurate data collection. Reviewed budgets and
performed business development. Prepared all required regulatory to
documentation to start each project, communicated with sponsor to
effectively the start-up process.
.

3. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
__________________________________________________________________________________________
__________________________________________________________________________________________
Curriculum Vitae
Engracia C. Ramirez
Page 2, Revised 8/16
Clinical coordination of numerous Phase II and Phase III studies for different
therapeutic areas. Demonstrated ability, efficiency and flexibility in working
at different clinic sites as needed to meet research department and staffing
needs. Responsible for assisting in the informed consent process, screening
potential patients for different clinical trials. Facilitated regulatory
management using FDA and USDA requirements. IRB reporting. Conducted
patient visits. Knowledge and utilization of Good Laboratory Practice (GLP),
Good Clinical Practice (GCP), and Hazard Analysis Critical Control Points
(HACCP).
Certified Senior Research Coordinator- Regulatory Compliance
Miami Research Associates(Phase I- II-IV)
6141 Sunset Drive, Suite 301/605
Miami, FL 33143
2008/2011
In charge of regulatory affairs operations from different clinicaltrials and research
study protocols. Coordinate and supervise the implementation and performance of
clinical trials, pharmaceutical and research studies per local and federal
regulations
Completion of Institutional Review Board (IRB) submissions and follow up
until getting final approval.
Coordinate and establish communication between research study sponsor
and clinical monitors with the clinical site. Review and audit clinical
researchrecords, correct any data discrepancy based on quality control and
quality assurance policies. Develop source documents and data
abstractions sheets, as well as their translations.
Create data base and perform data entry and establishment of
codifications.
Assist in writing proposals, budget creation and work plan for research
protocols.
Perform literature reviews to determine research topics and their
methodology.
Give trainings and orientations to personnel before study
implementation.
Conduct statistical analysis, including its explanation and description.

4. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
__________________________________________________________________________________________
__________________________________________________________________________________________
Curriculum Vitae
Engracia C. Ramirez
Page 2, Revised 8/16
Clinical Research Coordinator
Miami Research Associates (Phase II-IV)
Regulatory Specialist / Quality Assurance
6141 Sunset Drive, Suite 301
Miami, Fl 33143
1997/2004
Regulatory Coordinator
In charge of regulatory affairs operations from different clinicaltrials and research
study protocols.
Coordinate and supervise the implementation and performance of clinical trials,
pharmaceutical and research studies per local and federal regulations
Completion of Institutional Review Board (IRB) submissions and
follow up until getting final approval
Collaborate in the development and creation of questionnaires.
Update and organize clinical research protocol regulatory
documentation.
Transcribe clinical record to electronic data capture system.
Conduct risk reduction counseling and HIV testing.
Develop and carry out sexuality workshops to college students
assisting at the clinic.
Coordinate workshops for health providers.
Offer and collaborate in the orientation and education to the
community about research studies. Elaborate manuscripts, research
papers and/or abstracts based on results from research studies.
Interview, give risk reduction counseling, administer questionnaires
and offer orientation to potential and recruited participants for clinical
trials and research studies.
Conduct and coordinate outreach activities to recruit subjects for
research studies.
Develop and create progress reports,correspondence and any other document
based on clinical site performance, study results and/or clarification notes to
be informed to federal agencies and/or sponsor.
Prepare weekly visit schedules, patients visit calendars per their visit
windows and update patient’s registries
Supervise that all personnel have licenses, certifications and training
required.

5. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
__________________________________________________________________________________________
__________________________________________________________________________________________
Curriculum Vitae
Engracia C. Ramirez
Page 2, Revised 8/16
Research Experience:
Akebia: CKD/ Anemia Study 2015/2016
Akebia /Analysis Dialysis Dependent 2015/2016
Bristol Myer Squib: Hodgkin’s Lymphoma 2015/2016
IMMUNOMEDICS:Phase I NON-Hodgkin’s Lymphoma 2015/2016
IMMUNOMEDICS:Chronic Lymphocytic Leukemia 2015/2016
MEDIMMUNE:Phase I RA study 2015/2016
Fibrogen: CKD Anemia 2015/2016
GSK 200808: CKD Anemia
Iomai Corporation: Phase II Traveler’s Diarrhea, 2015/2016
VaxInnate: Bird Flu, 2015/2016
Sunovian: ADHD, 2015/2016
GSK Pharmaceuticals: Pandemic Influenza, 2015/2016
Pfizer: Elderly Staphylococcus Aureus Vaccine, 2015/2016
Dynavax Technologies: Healthy Vaccine, 2015/2016
Sanofi Pasteur:Influenza, 2015/2016
Pfizer: C Diff, 2015/2016
Pfizer: Hyperlipidemia, 2014/2015
Pfizer: Meningitis B, 2014/2015
Pfizer, Healthy, Phase I,2013/2014
MDVI, One-patient, Phase I,2013/2014
Pfizer, Non-child bearing potential, Phase I,2013/2014
Pfizer, Healthy Subjects, Phase I,2013/2014
Amgen, Hepatic-impairment and Healthy, Phase I,2013/2014

6. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
__________________________________________________________________________________________
__________________________________________________________________________________________
Curriculum Vitae
Engracia C. Ramirez
Page 2, Revised 8/16
Research Experience Continued:
Revive, Gout, 2013/2014
Otsuka, Alzheimer’s disease, 2013/2014
Vertex,Influenza Vaccine, 2013/2014
AstraZeneca,Otitis, 2013/2014
Takeda, Gout, 2013/2014
Tasly, Asthma, 2013/2014
Pharm Olam, Otitis, 2013/2014
Noven, Healthy, Phase I,2014
Merck, Healthy, Phase I, 2014
Pfizer, Parkinson, Phase II, 2014
PLx Pharma,non-insulin-dependent Diabetes Mellitus (NIDDM),
Phase III,2014
Pfizer, Healthy Males, 2014
Eli Lilly, Type II Diabetes Mellitus, 2014
Noven, Healthy, Phase I,2014
Pharmacyclics, Healthy and Rheumatoid Arthritis, Phase I,2014
NEOS Therapeutics, ADHD Pediatric, Phase I,2014
BMS, Healthy Females, Phase I,2014
Pfizer, Hypercholesterolemia, Phase I,2014
MedImmune, Healthy (Staphylococcus aureus),Phase I, 2013
BMS, Healthy Female, Birth control, Phase I,2013
ONO,Hepatic and Healthy, Phase I,2013
Amgen,Healthy, Phase I,2013
Amgen, Hepatic,Phase I, 2013
Synergy, Healthy, Phase I,2013
Pfizer, Diabetes, Phase I,2013
Pfizer, Healthy, Phase I,2013
Piramal, Overweight/Diabetes/Healthy, Phase I,2013
Eli Lilly, Type II Diabetes, Phase I,2013
AstraZeneca,Polycystic Ovary Syndrome, Phase IIa,2013
Amgen, Healthy, Phase I,2013
Asubio, Elderly, Phase I,2013
Pfizer, Renal, Phase I,2013
BMS, Birth Control, Phase I,2013
Pfizer, Healthy, Phase I,2013
Sucampo, Chronic Idiopathic Constipation, Phase III, 2013
Merck, HIV,Phase I,2013
Pfizer, Type II Diabetes,Phase I,2013

7. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
__________________________________________________________________________________________
__________________________________________________________________________________________
Curriculum Vitae
Engracia C. Ramirez
Page 2, Revised 8/16
Research Experience Continued:
MedImmune: Respiratory Syncytial Virus, 2013
Merck: Healthy Children’s, 2013/2014
Cereve:Primary Insomnia, 2013
Amgen: Cholesterol, 2013
Bavarian Nordic: Small Pox, 2013/2014
Pfizer: Neisseria Meningitis Vaccine, 2013/2014
Sanofi Pasteur:Rabies Vaccine,2013/2014
GSK Pharmaceuticals: H7N1 Vaccine, 2013
Medicago: Healthy, 2013/2014
Novartis: Seasonal Influenza, 2013/2014
PLx Technology: Diabetes,2013/2014
Pfizer: Healthy, 2014
Eli Lilly: Diabetes Mellitus, 2014
Merck: Phase I,2014
Novovax: Healthy, 2014
Genzyme: Osteoarthritis, 2014
Sanofi Aventis: Rheumatoid Arthritis, 2014
Noven Pharmaceuticals: Healthy, 2014
Bristol Meyers Squibb: Birth Control, 2014
Pfizer: Cholesterol, 2014
Pfizer: Healthy, 2014
Pax Vax: Cholera, 2014
Pax Vax: Cholera, 2014
MedImmune: RSV Vaccine,2014
Sanofi Aventis: Rheumatoid Arthritis, 2014
Amgen: Healthy, 2014
Mylan Pharmaceuticals: Testosterone, 2014

8. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
__________________________________________________________________________________________
__________________________________________________________________________________________
Curriculum Vitae
Engracia C. Ramirez
Page 2, Revised 8/16
Research Experience Continued:
MedImmune: Healthy, 2014
Piramal: Diabetes, 2013/2014
Pfizer: Diabetes, 2013/2014
Noven Pharmaceuticals:ADHD, 2013/2014
Merck: Device, 2013/2014
Noven Pharmaceuticals: DermalPatch, 2013/2014
Strategic 2013 /2014
Diabetic Foot Ulcer Phase I 2013 /2014
HPV L1 Vaccine2013 /2014
Pediatric Ear Infection 2013 /2014
Pediatric Asthma 2013 /2014
Asthma Study Phase III 2013 /2014
Constipation in Adults Phase III 2013 /2014
Chronic Idiopathic Constipation Phase III 2013 /2014
Type 2 Diabetes Mellitus Phase III 2011/2012
Chronic Non-Cancer Pain Phase III 2011/2012
Alzheimer’ Disease 2011/2012
Insomnia Study 2011/2012
Parkinson’s Disease 2011/2012
ADHD 2011/2012
NasalCongestion in Children Phase III 2011/2012
Colorectal Cancer Phase II 2011/2012
Prostatic Hyperplasia (BPH) 2011/2012
Diabetes Peripheral Neuropathic Pain Phase III 2011/2012
Post Traumatic Peripheral Neuropathic Pain Phase III
Multiple Sclerosis 2011/2012

9. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
__________________________________________________________________________________________
__________________________________________________________________________________________
Curriculum Vitae
Engracia C. Ramirez
Page 2, Revised 8/16
Research Experience Continued:
2009/2010 Migraine
2009/2010 Erosive Esophagitis
2009/2010 Active Rheumatoid Arthritis Phase III
2009/2010 Urinary Tract Symptoms (LUTS) Phase II
2009/2010 COPD Phase III
2009/2010 Irritable Bowel Syndrome Phase III
2009/2010 Prostatic Hyperplasia Phase II
2009/2010 Mild/Moderate Prodromal Alzheimer’s
2009/2010 Osteoarthritis of hip and
2009/2010 Insomnia Healthy Elderly Population
2009/2010 Prevention of Menstrual Related Migraine
2009/2010 Osteoarthritis of the Knee
2009/2010 Phase I insomnia Studies
2009/2010 Phase I Elderly Insomnia Studies
2009/2010 Migraines
2009/2010 Mild to Moderate Alzheimer's disease on Apo-
ECarriers
2009/2010 Mild to Moderate Alzheimer's disease on Non
Apo-E Carriers
2009/2010 Mild to Mod
2008/2008
2008/2008 Treatment of subjects with mild to Moderate
Alzheimer's disease
2008/2008 Flu Vaccine 2008/2008
2008/2008 Bird Flu Vaccine
2007/2008 Treatment of Subjects with Overactive Bladder

10. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
__________________________________________________________________________________________
__________________________________________________________________________________________
Curriculum Vitae
Engracia C. Ramirez
Page 2, Revised 8/16
Research Experience Continued
2007/2008 Treatment of Subjects with Daily Headaches
2007/2008 Antiplatelet Therapy
2007/2008 Cohn's Disease
2007/2008 Erosive Esophagitis
2007/2008 Ulcerative Colitis
2007/2008 Hypercholesterolemia
2007/2008 Migraine
2007/2008 Overactive Bladder
2007/2008 Persistent Cough
2007/2008 Hypercholesterolemia
2007/2008 Hypercholesterolemia and Low HDL
2007/2008 DiabetesType2
2007/2008 Multiple Sclerosis
2001/2002 Hypercholesterolemia
2001/2002 BPI-I
2001//2002 Asthma
2000/2001 Mixed Hyperlipidemia
2000/2001 COPD
2000/2001 Hypercholesterolemia with Mixed Hyperlipidemia
2000/2001 Diabetes Dyslipidemia
2000/2001Alzheimer's disease
2000-2001 Bipolar Disorder
2000-2001 Irritable Bowel Syndrome
1998/1999Irritable Bowel Syndrome Diarrhea
1998-1999 Parkinson's disease
1998-1999 Alzheimer's disease
1997-1998 Alzheimer's disease
1997-1998 Insomnia Study
1997-1998 Parkinson's disease
1997-1998 ADHD
1997-1998 Partial Seizures
1996-1997 Alzheimer's disease extension study
1996-1997 Alzheimer's disease

11. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
__________________________________________________________________________________________
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1996-1997 Juvenile Myoclonic Seizures
Training:
CITI Collaborative Institutional Training
CITI GCP Certification
Certificate of Recognition (HIPAA- The Privacy Rule on February)
GCP for Clinical Trials with Investigational Drugs and Medical Devices
Overview of New Drug Development
Overview of ICH GCP
FDA Regulated Research and ICH for Investigators
ICH - Comparison between ICH GCP E6 and U.S. FDA Regulation
Investigator Obligations in FDA-Regulated Clinical Research
Managing Investigational Agents According to GCP Requirements
Overview of U.S. FDA Regulations for Medical Devices
Informed Consent
Detecting and Evaluating Adverse Events
Reporting Serious Adverse Events
Audits and Inspections of Clinical Trials
Monitoring of Clinical Trials by Industry Sponsors
Completing the CITI GCP Course
IATA Training (Transport of Dangerous Goods Certification)
Computerized Systems:
OCRDC 2015/Present
Inform 4.5, 4.6, 5.0 2015/Present
e-N@ble 2014/2015
Clinasyst 2014/2015
SynCapture 2014/2015
RAVE 2013/2014
Clinical Conductor 2013/2014
Timeaus 2010/2011
DataLabs 2010/2011
iMedidata 2009/2010
Medrio 2009/2010
Trial Master 2009/2010
AptivAdvantage 2009/2010

12. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
__________________________________________________________________________________________
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Curriculum Vitae
Engracia C. Ramirez
Page 2, Revised 8/16
Skills Proficient in all Microsoft Office Programs including:
Microsoft Office Word
Microsoft Office Excel
Microsoft Office PowerPoint
Regulatory Knowledge
Code of Federal Regulation, Title 45, Part 46
Code of Federal Regulations, Title 21, Part 11
Code of Federal Regulations, Title 21, Part 54
Code of Federal Regulations, Title 21, Part 54
Code of Federal Regulations, Title 21, Part 56
Code of Federal Regulations, Title 21, Part 312
Professional Development Trainings
AIDS (DAIDS) Clinical Quality Management Training
Division of AIDS (DAIDS) Protocol Registration Policy and Manual
OC-RDC onsite data entry
Intralinks
RTRN-DTCC Seminar in Translational Research Methods:
Statistical Issues
Research Aspects of HIPS/HIPAA
Impala e-training Guide
OraQuick Advance HIV-1/2
Risk Reduction Counselling (RRC) Worksheet - Webinar training
Infection Control: HIV, TB, Hepatitis B
AIDS Clinical Trial Network (ACTN) Pharmacokinetic Tutorial
Health Insurance Portability and Accountability Act (HIPPA)
Protection Human Research Participants
Good Clinical Practice (GCP)

13. ENGRACIA C. RAMIREZ, CCRC
ecramirez5502@gmail.com Phone: 828-773-9625
__________________________________________________________________________________________
__________________________________________________________________________________________
Curriculum Vitae
Engracia C. Ramirez
Page 2, Revised 8/16
Technical Skills
American Heart Association CPR
Organization Member
2016 – Present Association of Clinical Research,ACRP
Languages:
Fluent in English and Spanish