CINTHIA MARIBEL RIVAS MOREL

*** **** ***** **. ********* E64, Bronx NY 10463

aczf86@r.postjobfree.com Mobile: 917-***-****

EDUCATION:

Master Degree in Strategy Business. Pontificia Universidad Católica Madre y Maestra (PUCMM). Santo Domingo, Dominican Republic. 2003-2006.

BA in Business Administration. Pontificia Universidad Católica Madre y Maestra (PUCMM). Santo Domingo, Dominican Republic. 1997-2002.

THERAPEUTIC EXPERIENCE:

Dermatology – Actinic Queratosis Phase II

Gastroenterology – Defense Gases Phase III

Orthopaedics – Osteoarthritis Phase III

Rheumatology – Rheumatoids Arthritis Phases II to IV

Musculoskeletal – Musculoskeletal Pain Phase III

Respiratory – Acute Influenza Phase III

Vaccine/Pediatric – Flu Vaccine Phase III

Vaccine/Pediatric – Acute Otitis Media & Pneumonia Phase II

Reproductive Health – Emergency Contraception Phase I

Device – Skin Treatment Device Phase IV

Skin & Hair Care – Cosmetology, Hair Products, Anti-Aging Creams, Moisturizers Phases I to IV

COMPUTER AND TECHNICAL SKILLS:

Cosmetology Instruments for Study Assessments: Cutometer, Corneometer, Siascope, Moisturemeter, Vapormeter, Chromameter. Trained by Site staff during Apr – Jul 2016

e-n@ble 4.0 “certified user” Course Nov 2011, Feb 2013

RDE “Certified User” Course Nov 2011.

OCRDC “Certified User”, Course March 2009, May 2013

IMPALA “Certified User”, Course March 2009.

Proficiency with MS Office, Microsoft Word, Excel, Power Point, Publisher, Outlook.

PROFESSIONAL EXPERIENCE:

INTERNATIONAL RESEARCH SERVICES, INC NY- USA, Apr 2016 – Feb 2017

Clinical Research Coordinator (CRC)

Writing and reviewing Protocols

Writing and reviewing Inform Consent Forms

Developing source documents

Reviewing final reports

Study product tracking and reception

IRB submission

Study visits conduction

Developing regulatory binder

Communications with Sponsor and study related meeting attendance

GLAXO SMITH KLINE (GSK) Santo Domingo, Jan 2014 – Mar 2015 & Jan 2013 – Mar 2013,

Panama City, Nov 2011 – Jul 2012

Clinical Research Associates (CRA) – Home Based/Onsite Monitoring

Prepare and Conduct pre-study visit, site initiation, interim monitoring visits and close out visit activities at clinical investigative site to ensure adherence to Protocol related procedures in accordance with FDA regulations

Generate study specific documentation including monitoring trip reports, telephone contact reports, site correspondence and expenses reports

Involved in site selection

Serve as a mentor with new CRA and guide them through all clinical trials related activities

Maintain site files, trial master files and study documentation

Develop CRF for Clinical Trials

Attend investigator’s meetings

Interim monitoring visits meeting with site staff and re-training when applicable

IRB submission

Develop site status reports, SOP revisions and document QC

Track clinical trial supplies, study product, patient recruitment activity, protocol deviations and SAEs

Revision of CRF, queries and queries resolution and SDV

PI and Site staff training to ensure understanding of all protocol activities and procedures

Handling multiple sites and Protocols at the same time

HRA-Pharma – CRO Chiltern (Freelancer) Santo Domingo, Mar 2013 – Nov 2013

Clinical Research Associates (CRA) – Home Based/Onsite Monitoring

Prepare and Conduct pre-study visit, site initiation, interim monitoring visits and close out visit activities at clinical investigative site to ensure adherence to Protocol related procedures in accordance with FDA regulations

Generate study specific documentation including monitoring trip reports, telephone contact reports, site correspondence and expenses reports

Involved in site selection

PK investigation

Maintain site files, trial master files and study documentation

Develop CRF for Clinical Trials

Attend investigator’s meetings

Interim monitoring visits meeting with site staff and re-training when applicable

IRB submission

Develop site status reports, SOP revisions and document QC

Track clinical trial supplies, study product, patient recruitment activity, protocol deviations and SAEs

Revision of CRF, queries and queries resolution and SDV

PI and Site staff training to ensure understanding of all protocol activities and procedures

RESEARCH CONDUCTING GROUP (RCG) Santo Domingo, Sep 2011 – Mar 2015

Partnership

Administrate, conduct, assist and organize with an excellent quality, experience and efficacy clinical trials upon with the Good Clinical Practice

Liaise between Sponsor and Investigator

Develop all regulatory process including clinical trials preparation and submission to IRB

Track Study product and submit and request importation license to MOH

Coordination and monitoring support

Site staff training

Attend and perform site staff meetings upon Sponsor request

LATIN AMERICAN RESEARCH (LAR) - MIAMI RESEARCH ASSOCIATES (MRA) Santo Domingo, Sep 2007 – Oct 2011

Clinical Research Coordinator (CRC)

Attendance to numerous Clinical Research Coordinator trainings on MRA (LAR’s sponsor) facilities in Miami, Fl

Facilitate communication between Monitor and Investigator

Ensure Protocol activities and procedures accomplishment under Good Clinical Practice

Ease shipping arrangements of study drugs, utensils and devices to be used by patients during the Study

Capture a good quality data from patients to maintain perfect agreement between CRF and patient source document

Patient study qualification

Capture and inform to PI, Sponsor and IRB protocol deviations and serious adverse event

queries resolution on time

Assist the Investigator to fill out feasibility forms

Conduct regulatory and submission process of clinical trials to IRB

Submit request of study product importation license to MOH

Maintain regulatory binder in order ready to be review by monitor upon request

Develop any patient or study report upon request

Attendance to investigator’s meeting and study trainings

Help Investigator to find strategies for patient recruitment process (were and how to recruit these patients, if an outsourcing recruiter is needed, which local media is going to be used and if so how is going to be announced)

Asociación Popular de Ahorros y Préstamos Santo Domingo, Feb 2002 – Feb 2007

Bank Branch Manager

Supervise between 2 to 10 staff members depending the size of the Branch I was working at that time

Serve as a leader to the team on which they learn and self-motivate

Maintain a good team work environment

Achieve Bank monthly goals and task

Knowledge of all Bank products to achieve new customer/clients to instruct them the best product to fit their needs

Develop statistical monthly reports

Supervise that Bank tellers do their work efficiently, trustable and according with Bank regulations

RELEVANT COURSES/TRAINING:

GCP course virtual training GSK/PPD, Dec 2014.

Astra Nova online training in Good Clinical Practice (GCP), Nov 2012.

Project Training Monitors Meeting, GSK Panama, (Protocol Overview), GSK code of conduct, monitoring and closeout activities, RDE-SBIR training and data management, GSK SOP, Nov 2011, Panama.

Miami Research Associates (MRA) Good Clinical Practice Course, Basic Course. September 2010, Online Training.

GCP for Investigational Site Staff Version 1.2. Online Course from Pfizer. September 2010.

EXL Pharma. 5th Latin American Clincal Trials, August 19-20’ 2010, Buenos Aires, Argentina.

ePharma Solutions. Online Training, for PFIZER protocols A3921024 (Central Laboratory, Drug Supply, eCRF and Protocol Overview), A3921064 (Protocol Overview), A3921046 (Protocol Overview), CP-690,550 Pfizer Cardiovascular and Malignancy Safety Event Reporting Process and Safety Reporting AE & SAE. November 2009.

Collaborative Institutional Training Initiative (CITI). Online training, Refresher Course September 2009.

Webinar March 31, 2009. Data management for Clinical Trials

Miami Research Associates (MRA), October 2008. Training on Rheumatoid Arthritis (Diagnosis of RA, Observation, Phase I RA, DMARTS and most common drugs used); Source Documentation; Study Procedures; LAB (Phlebotomy, Processing, Packing and Shipping; Extensive Review of TRX-2008 Protocol; ALZHEIMER`S.

XI Good Clinical Practice, October 9-11 2008, CONABIOS, Dominican Republic.

Shipping Class 6.2 Dangerous goods 2008 Compliance Training Reference Manual, (SAF-T-PAK), October 2008.

Miami Research Associates (MRA), February 2008. Training on Actinic Keratosis, Weigh Loss, Nutrition.

National Institutes of Health (NIH). Online training in Human Participant Protections Education for Research Teams, November 2007.

Miami Research Associates (MRA), September 2007. Training on Osteoarthritis, Flu Vaccine.

Collaborative Institutional Training Initiative (CITI). Online training, Basic Course September 2007.

LANGUAGE:

Spanish (native)

English (fluent – writing, reading and speaking)

Contact this candidate