Clinical Research Coordinator
Resume:
Maria Barber
PhD, FMG, CCRC
Miami, FL *****
adoz20@r.postjobfree.com
• PhD in Biomedical Science, 2007, Cubs
• Former A&P Adjunct Faculty, Management Resource College and Miami Regional University
• Quality assurance specialist
• CCRC
• Medical Doctor Higher Institute of Medical Science of Havana, 1984, Cuba Work Experience
Quality Assurance Specialist
Miami Dade Medical Research Institute - Miami, FL
February 2018 to September 2020
Miami, FL Feb 2018 - 03-Sep-2020
8955 SW 87th Court Suite 112, 110, 210. Miami, FL 33176 Clinical Research Quality Assurance / Quality Improvement (QA/QI) Responsible for safe and effective implementation of clinical trial protocols and ensuring that protocols are conducted, recorded, and reported in accordance with the protocol, standard operating procedures
(SOPs), ICH-
GCP, and all applicable regulatory requirements.
• Oversees the data entry from the source document to the electronic case report form.
• Works with the clinical research coordinators to design and or revise the data collection forms and standard communication documents as needed.
• Works with the clinical research coordinators to help identify and document areas for clarification and improvement.
• Works with clinical research coordinators to clarify inconsistencies with the data to ensure integrity and quality of research data.
• Assists clinical research coordinators in preparation of scheduled monitoring visits.
• Assists clinical research coordinators with research database audits.
• Perform clinical trial internal audits at the site on daily bases.
• Review and update the site SOPs every two years. Write the site SOP under COVID-19 conditions.
• Verifies and corrects data as needed and queries resolution.
• Imparts training to the site staff on all related clinical and regulatory information.
• Review and receive trainings on existing online platforms for fixing the clinical research to remote work under COVID-19 conditions and beyond
• Ability to maintain a positive attitude with the research team.
• Maintain professional demeanor with sponsors, monitors and auditors.
• Remains current with all required trainings.
• Complies with all applicable regulations, guidelines and procedures pertaining to clinical research data management.
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American Heart Association Basic Life Support (CPR and AED) Program April 2020 to April 2020
• Webinar: How sites and sponsors are collaborating to move eSource forward. Alvarado, April, 2020.
• Course: American Heart Association Basic Life Support (CPR and AED) Program, January, 2020. eCourse
October 2019 to October 2019
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• e Course: The comments to editors and decision recommendations. Research Academy, ELSEVIER, eCourse
September 2019 to September 2019
• e Course: The typical peer review process. Research Academy, ELSEVIER, September, 2019
• e Course: How to get involved. Research Academy, ELSEVIER, September, 2019
• e Course: I just got a review invite, what's next? Research Academy, ELSEVIER, September, 2019
• Webinar: How to Engage Your IRB to Improve Clinical Trial Risk Management. Advarra, September, 2019 eCourse
September 2019 to September 2019
• Webinar: Preparing for Multisite Gene Therapy Studies. Advarra, September, 2019
• Webinar: Making Mobile Clinical Trials a Reality. Advarra, September, 2019 Researcher Academy
eCourse
April 2019 to April 2019
Webinar Replay: The Impact of Virtual Research: What You Need to Know About Mobile Apps, Wearables and Remote Data Collection. ACRP, September 4, 2018. ACRP
2017 to July 2018
Certificated Clinical Research Coordinator
CPR
2017 to April 2018
• 2.4- The Seismic Shift in the Monitoring Paradigm: From Quality Control to Quality Assurance. ACRP-2017-
OCL-104. April 5, 2018
• Foreign Medical graduate
• IATA certified
• ICH-GCP certified
• Certificated Clinical Research Coordinator
• Medical terminology Knowledge
• Substantial experience using computerized information systems
• Knowledge of ICD-9
• Medical Assistant Certification
• CPR Certification
• Annual OSHA Training
• Registered Medical Assistant
• Spirometry training
CCRC
• Certification Exam
• Medical Assistant CEUs
• IATA
• EDC trainings: Medidata Rave, Oracle, Yprime, InForm 6.0
• IVRS/IXRS trainings: Clinphone, Almac, Cenduit, Webez
• Belmont Report and CITI Course Introduction
• 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 Regulations
• Conducting Investigator-Initiated Studies According to FDA Regulations and GCP P a g e 4 12
• 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. ACRP ARMA Mayo Clinic
• AstraZeneca, Novartis, Boehringer Ingelheim, Novum, Fibrogen, Cellceutix, Evidera, COVANCE Physiology and Pathophysiology
University of Medical Sciences of Havana. Havana, Cuba
• Physiology of nutrition, distribution, excretion and energetic exchange
• Physiology of Regulating Systems (Nervous and Endocrine systems)
• Physiology training techniques: blood chemistry, coagulation and blood groups classification, EKG, direct and indirect methods of measurement of blood pressure, respiratory function tests, renal plasma clearance and urodynamic test, nutritional balance, metabolic rate and oxygen consumption, electrophysiological recording techniques, sensory and motor exploration.
• Physiology of the Cardiovascular System
• Renal plasma clearance
• Arterial hypertension workshop
• Prevention of chronic kidney disease
Laboratory.
Experimental animals University of Medical Sciences of Havana. Havana, Cuba
• Basic experimental microsurgery
Bio-Chemistry and Lab.
Cellular and Molecular Biology
University of Medical Sciences of Havana. Havana, Cuba Basic courses.
General Chemistry University of Medical Sciences of Havana. Havana, Cuba Organic Chemistry, Physics, Physics Chemistry, Research Methodology, Management of scientific information, Computing, Mathematics, Statistics and Biostatistics. Primary Clinical Research Coordinator
Vida Medical Research, Inc - Hialeah, FL
February 2016 to June 2017
Responsible for safe and effective implementation of clinical trial protocols and ensuring that protocols are conducted, recorded, and reported in accordance with the protocol, standard operating procedures
(SOPs), ICH-
GCP, and all applicable regulatory requirements.
• Responsible for clinical communication with Sponsors, CRO and/or SMO for Site/Principal investigator enrollment and participation in clinical trials.
• Responsible for clinical communication with central IRBs and maintaining ethical approval for the studies, from initial study approval through study amendments, annual continuations, and finally termination.
• Working with contracts and budgets with study Sponsors/CRO from study start-up until its completion.
• Responsible for all the clinical trial regulatory tasks.
• Responsible for recruiting subjects for clinical trials.
• Responsible for subject's enrollment via Yprime or IXRS ALMAC.
• Conducted day-to-day execution of clinical research protocols including obtaining informed consent, completing study procedures, designing and completing source documents.
• Responsible for clinical tasks including vital signs and body measurements.
• Documented and conducted appropriate correspondence and reports regarding adverse events and serious adverse events.
• Conducted subject trainings such as online survey and migraine symptoms identification.
• Responsible for subject register in ClinCard System visit payment request.
• Responsible for data entry on eCRFs and query solutions.
• Responsible for coordinating all the procedures out of the site. Primary Clinical Research Coordinator
L&C Professional Medical Research Institute - Miami, FL March 2015 to January 2016
Responsible for safe and effective implementation of clinical trial protocols and ensuring that protocols are conducted, recorded, and reported in accordance with the protocol, standard operating procedures
(SOPs), ICH-
GCP, and all applicable regulatory requirements.
• Primary Research coordinator to different studies.
• Responsible for clinical communication with Sponsors, CRO and/or SMO for Site/Principal investigator enrollment and participation in clinical trials.
• Responsible for clinical communication with central IRBs and maintaining ethical approval for studies, from initial study approval through study amendments, annual continuations, and finally termination.
• Working with contracts and budgets with study Sponsors from study start-up until its completion.
• Responsible for recruiting subjects for clinical trials.
• Responsible for subject's enrollment via IWRS/IVRS. (Clinphone, Almac, Cenduit and others)
• Conducted day-to-day execution of clinical research protocols including obtaining informed consent, completing study procedures, and dispensing, accounting for study drug, documenting drug compliance and completing source documents.
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• Responsible for clinical tasks including vital signs, body measurements, ECG and centralized spirometry and pulmonary function testing (ERT). - Documented and conducted appropriate correspondence and reports regarding adverse events and serious adverse events.
• Conducted subject trainings such as handling Diarys, Electronic Patient Reported Outcome device, Electronic Peak Expiratory Flow device and disease symptoms identification.
• Subject advisor in general sanitary measures in those participating in Infectious Disease studies.
• Assisted to sub-investigator with Joint Count Assessment in subject having Rheumatoid Arthritis.
• Responsible for data entry on CRFs and eCRFs as well as query solutions.
• Responsible for doing lab, ECG and spirometry supply requests. - Advising and participating with techniques implementation and Lab procedures according to protocols.
• Responsible for weekly scheduling appointment and subjects' transportation. Titular Investigator
University of Medical Sciences of Havana - Havana, CU November 1992 to April 2013
Cuba
Faculty of Medical Sciences Enrique Cabrera and Institute of Basic and Preclinical Sciences Victoria de Giron Nov 1992- Apr 2013
Havana, Cuba
Titular Investigator (Top rank Academy of Science, Cuba) The following studies were performed:
• Morphological and functional study of renal variables in essential hypertensive and prehypertensive young adults.
• Mortality by Cardiogenic Shock in Primary Coronary Angioplasty. Institute of Cardiology and Surgery University of Medical Sciences of Havana
2004 to 2009
University of Medical Sciences of Havana
October 2005 to December 2008
Generation of experimental arterial hypertension model in rat with proximal tubular hypertrophy (AH- TH).
It was developed trought renin-angiotensin inhibitors administration to rats (ACE inhibitors, AT1 antagonist, β-blokers). Renal morphofunctional and systemic hemodynamic variables were studied.
• Evaluation of glomerular-tubular imbalance with a tubular predominance, in low-birth-weight model
(artery uterine ligation). Functional and morphological renal parameters were determined as well as systemic hemodynamic variables.
• Prevention of renal injury after induction of ozone tolerance in rats submitted to warm ischemia. Biochemical parameters as fructosamine level, phospholipase A, and superoxide dismutase activities, as well as renal plasma flow and glomerular filtration rate, were determined.
• Mononuclear phagocytic cells in rats treated with ozone. Studying of the phagocytic capacity of macrophages/monocytes to aseptic inflammation model treated with intraperitoneal ozone.
• Blood volume and urinary excretion in hypertensive rats treated with nifedipine or diuretics. It was used AH-TH rat model. Nifedipine, furosemide and Bidens Pilosa effects were studied. Plasma volume, hematocrit, urinary excretion for 24 hours, urine osmolality and urinary excretion rate, were determined. Education
PhD in BioMedical Sciences
University of Medical Sciences of Havana - Havana, CU 2007
Specialist
University of Medical Sciences of Havana - Havana, CU 1992
Doctor in Medical
Higher Institute of Medical Sciences of Havana - Havana, CU 1984
Skills
• CRCC: Sources Documents, SOPs, eCRF, IVRS/IWRS, handling of subjects, EKG, vital signs, spirometry. Regulatory coordination, strong organizational skill and pay attention to the detail.
• Physiology/Pathophysiology: Erythrocyte sedimentation rate, hematocrit, globular resistance, coagulation and blood groups classification; EKG, direct and indirect methods of measurement of blood pressure, ergometrics test; respiratory function tests; renal plasma clearance using standard and single injection methods, urodynamic testing; nutritional balance determination, Maria Barber, PhD, FMG, CCRC, RMA P a g e 5 12 metabolic rate and oxygen consumption; sensory and motor exploration; electrophysiological recording techniques; experience with animal models and clinical research.
• Biochemistry/molecular: PCR, agarose gel electrophoresis, histochemistry, collection, analysis and reporting of data. Chemistry: Stock solution and media preparation, Spectrophotometry. LANGUAGE:
• Spanish: Native or bilingual proficiency, written and oral.
• English: Professional proficiency, written and oral. RATING EXPERIENCE: ABS
• (Agitated Behavior Scale) 2012-Present ADAS-cog- (Alzheimer's Disease Assessment Scale-Cognitive Subscale) 2012-Present ADCS-ADL- (Alzheimer's Disease Cooperative Study
• Activities of Daily Living) 2012-Present ADCS-CGIC- (Alzheimer's Disease Cooperative Study
• Clinical Global Impression of Change) 2012-Present ADCS-CGIC-Overall
• (Alzheimer's Disease Cooperative Study
• Clinical Global 2012-Present Impression of Change Rating) CDR- (Clinical Dementia Rating Scale) 2012-Present CGIS-Agitation
• (Clinical Global Impression of Severity of Illness-Agitation) 2012-Present CMAI- (Cohen
• Mansfield Agitation Inventory) 2012-Present CSDD- (Cornell Scale for Depression in Dementia) 2012- Present C-SSRS- (Columbia-Suicide Severity Rating Scale) 2012-Present DEMQOL
• (Dementia Quality of Life) 2012-Present EQ-5D-5L (EuroQol 5 Dimension) 2012-Present FAQ
(Functional Activities Questionnaire) 2012-Present GMHR
• (General Medical Health Rating) 2012-Present HCRU
• (Health Care Resource Utilization) 2012-Present mADCS-CGIC-Agitation
• (Modified Alzheimer's Disease Cooperative Study
• Clinical Global 2012-Present Impression of Change Rating) MMSE- (Mini-Mental State Examination) 2012-Present NAB
• (Naming Test) 2012-Present NIS (Neuropathy Impairment Score) 2012-Present NPI- (A Neuropsychiatric Inventory) 2012-Present OAS
• (Overt Aggression Scale) 2012-Present PGIC
• (Patient Global Impression of Change) 2012-Present Phonetic and Semantic Verbal Fluency
• (i.e. COWAT- controlled Oral Word Association 2012-Present Test) QoL-AD
• (Quality of Life
• Alzheimer's Diseases) 2012-Present RAVLT
• (Rey Auditory Verbal Learning Test) 2012-Present RUD/RUD-Lite- (Resource Utilization in Dementia Questionnaire) 2012-Present SAS (Survey of Autonomic Symptoms) 2012-Present SDMT- (Symbol Digit Modalities Test) 2012-Present SF-36 (Health and Well-Being) 2012-Present Maria Barber, PhD, FMG, CCRC, RMA P a g e 6 12 S-STS
• (Sheehan Suicidality Tracking Scale) 2012-Present TUG
• (Timed Up and Go test) 2012-Present VAS (Visual Analog Scale) 2012-Present WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) 2012-Present ZBI
• (Zarit Burden Interview) 2012-Present
• Microsoft Excel
• EMR systems
• Data collection
• Medical terminology
• Teaching
• Oracle
Assessments
Written communication — Proficient
May 2021
Best practices for writing, including grammar, style, clarity, and brevity Full results: Proficient
Proofreading — Highly Proficient
May 2021
Finding and correcting errors in written texts
Full results: Highly Proficient
Indeed Assessments provides skills tests that are not indicative of a license or certification, or continued development in any professional field.
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