Clinical Research Trials, Foreign Graduated M D, Senior CRC
Resume:
Nieves A. Andino,
FGMD, Reproductive Endocrinologist, Clinical Biochemist
RESUME
Email: ******.******@*****.***
Education:
- Medical School, Faculty of Medicine, Havana University, Cuba (Medical Doc tor)
- Internship and Residency in Clinical Biochemistry, National Center for Scien- tific Research (CNIC), Havana, Cuba (Clinical Biochemist Specialist)
- Specialist in Clinical Biochemist Grades I and II in Reproductive Endocrinol- ogy. National Institute of Endocrinology, Hospital Cdte Manuel Fajardo, Ha- vana, Cuba (INE). (Reproductive Endocrinologist)
- Senior Investigator in Reproductive Endocrinology, Academy of Sciences, Havana, Cuba (Senior Researcher, PhD)
- Dr. In Science, National Academy of Sciences, Havana, Cuba Post Graduate Studies
World Health Organization (WHO) Fellowship on: RIA Techniques for Human Reproduction Hormones at St. Mary’s Hospital, London, GB and Medical Re- search Council (MRC), Scotland, GB.
WHO Training on Clinical Trials on Hormonal Contraceptives. Dept. En- docrinology, King’s College Hospital, London, UK
WHO Training on Clinical Trials for the Introduction of new Drugs in Countries following WHO Guidelines, WHO, Geneva
WHO Fellows. : A) In Vitro Research Studies on Ovarian Physiology and tech- niques for ovarian receptors determinations. B) Clinical Research Studies on Prolactin related Infertility. Dept. of Physiology, University of Manitoba, Win- nipeg, Canada.
WHO SRH Programme Fellows on: A) Tissue Culture, Hormonal Laboratory and Clinical Aspects of In Vitro Fertilization in the In Vitro Fertilization Programme of Sahlgrenska Hospital, Gothenburg, Sweden and Dr. R. Edwards Department, Bourn Hall, England; B) Immunology of Reproduction and Medical Assisted Conception techniques, OBG Dept., Erasmus University, Rotterdam, Holland.
Nieves A. Andino,
FGMD, Reproductive Endocrinologist, Clinical Biochemist RESUME
Email: ******.******@*****.***
Working Experience other than in USA
Clinical and Basic Research in General Endocrinology and Reproductive Endocrinology
• Head of Human Reproduction Laboratories, National Institute of Endocrinology, (INE) Havana, Cuba
• Director of the Cuban In Vitro Fertilization Programme (INE/OBG Hospital Gonzalez Coro), Cuba
• Head of the Male and Female Gamete Tissue Culture an Research Laboratories of the INE, Cuba
• Head of HRP/WHO Cuban Team for the Development of Regional Radioimmunoassay Kits for Latin America and the Caribbean.
• Head of the Development, Conduction and Monitoring/Evaluation of World Health Organization
(WHO) Clinical trials Phases I, II III and IV.
•
• Head of the Clinical and Basic Research Group in Reproductive Endocrinology at the National Institute of Endocrinology, INE, Havana, Cuba
• WHO Chief Technical Adviser for Sexual and Reproductive Health for Latin America and the English/Spanish and Dutch-speaking Caribbean (Geneva, Panama, Nicaragua, Mexico, and Tri- nidad and Tobago 1993-2008)
Working Experience in USA 2015-present
09/2015-03/2016 Main Clinical Research Coordinator (CRC) for two Clinical Trials (CIRT and NAFLD) at Dr. DDelaVega Research Group, Miami, Florida. (left for offer for a better post)
06/2016 - 02/2019 Main CRC at MedCare Research Clinic, Miami, Florida; responsible for all aspects of the conduction of seven (7) Clinical Trials, (from blood processing to the regu- latory aspects.). (also left for offer for a better post) 02/2019 - 10/2019. Main CRC for two Clinical Trials at South Florida Clinical Research, Miami, Flor- ida, and assistant CRC for 5 Clinical trials.
10/2019 - 03/2020. Main CRC for two Clinical Trials at SunCoast Research Group LLC, Miami, Flor- ida; and Assistant CRC for five other Clinical Trials. Languages:
Spanish 100% (mother tongue)
English 100% (like mother tongue)
Nieves A. Andino,
FGMD, Reproductive Endocrinologist, Clinical Biochemist RESUME
Email: ******.******@*****.***
German 60%.
French Basic level
Computer Skills: 3 Proficiency on Microsoft Office Programmes Publications: See Annex II
TRAININGS AND CERTIFICATES USA
Belmont Report and CITI Course Introduction
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 Regulations Conducting Investigator-Initiated Studies According to FDA Regulations and GCP 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
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