Dr
Fermin R. Viera, CNHP
P.O. Box 21761, Fort Lauderdale, Florida 33335-1761.
Home-Office: (954) 493-5484. (954) 202-1860.
Fax: (954) 202-1983. Mobiles: (954) 479-6099. (954) 551-9228.
E-Mails: DrFerminViera@ and Fermin1954@
OBJECTIVE:
To obtain a Clinical Research, Medical, Paramedical, Pharmaceutical, Medical Science Liaison,
Educational, Management related position with a growing, progressive, and expanding organization.
EDUCATION
• Present Time. American Heart Association BLS Instructor.
• Present Time. American Heart Association Core Instructor.
• Present Time. American Heart Association BLS / CPR for Health Care Providers.
• 2002-2003 C.N.H.P., (Certified Natural Health Professional), The National Association of Certified Natural Health Professionals - Warsaw, IN
1. 1978-1984. M.D., (Doctor of Medicine) – Universidad Central Del Este, School of Medicine, San Pedro de Macoris, Dominican Republic
2. 1974-1977. Essex County College, Newark, NJ – Completed pre-medicine requirements
3. 1973-1974. Rutgers University - Newark, NJ - Completed pre-medicine requirements
4. Fully Bilingual, (Spanish-English).
5.
WORK EXPERIENCE
CLINICAL RESEARCH OVERVIEW. THERAPEUTIC AREAS PHASES I THROUGH IV:
CNS, Endocrinology, (Diabetes, Juvenile, Types 1 & 2, Insulin & Non-Insulin Dependent, with Hypertension, Obesity, Hypercholesterolemia, Nephropathy ), Hematology, Respiratory, (Asthma, COPD, RTI), Immunology, Rheumatology-Arthritis, Neurology, Internal Medicine, Pain Management, (Neck, Back, Limbs, Joints, Nerves, and General Musculo-Skeletal), Infectious Diseases, Antibiotics, Antifungals, Antiparasitics, Ophthalmology,(Conjunctivitis, Glaucoma, Diabetic Retinopathy, Cataracts), Behavioral, Psychiatry, Osteoporosis, Substance Abuse, Nephrology, Urology, HIV, Dermatology, Vaccines, Marital and Sexual Health, Cardiology, Cardiovascular, (Catheterization Lab, CHF, Cholesterol, HTN), Psychiatry/Psychotropics, OB/GYN, Fertility, Oncology,(Lung, Breast, Cervix, Prostate, Multiple), Organ Transplant, Surgical, Medical Devices, (AED’s, ET and EOA tubes, oropharyngeal airways, orthopedics, limbs’ prosthesis, implants, nasogastric tubes, catheters, syringes, stents).
08-2009 to Present. Health and Fitness Screener. Florida, and Nationwide, USA
Health Fitness Corporation.
Minneapolis, MN
Health screening evaluates the health status and potential of individuals, obtaining information with regards to their health. Evaluations will focus on either a particular disease or condition, determining if they are at greater-than-normal risk. Health screening may include taking a personal and family health history and performing a physical examination, tests, laboratory tests, or radiologic examination and may be followed by counseling, education, referral, and/or further testing. Freelance, per diem.
04-2008 to Present. Freelance clinical research, medical consulting, and Spanish Radio programs/shows advisor and commentator for nutritional products. Freelance per diem clinical research consulting, business development, quality assurance, sales, compliance control, and/or market research for various companies and institutions, and medical nutritional nationwide Spanish radio programs/shows such as Univision, and Spanish Broadcasting System networks, as an advisor and commentator for various companies with nutritional products. Sales, marketing and business development. All freelance part time. All contracts are confidential.
11-2007 to 03-2008. Senior CRSM, (Clinical Research Study Manager), Home-Based.
Pfizer Pharmaceuticals.
Fort Lauderdale, Florida and Southeast region, Florida and Puerto Rico.
Responsible for monitoring all clinical trial study sites assigned to my region. Multi-therapeutic areas, mostly Cardiovascular, Hypertension, CHF, Respiratory, Endocrinology, Diabetes, CNS, Rheumatology, Infectious Diseases, among many others. Initiation of clinical and hospital sites, routine monitoring for protocol adherence, regulatory document compliance, case report form review, hospital charts, collating and resolving queries on data from allocated clinical trials. Work done bilingually, Spanish and English.
08-2006 to 11-2007. Senior CRA, Home-Based.
Novartis Pharmaceuticals.
Fort Lauderdale, Florida and Southeast Region, Florida.
Responsible for monitoring all study clinical trial sites with multi-therapeutic areas, mostly cardiovascular, HTN, CHF, CVA/STROKE, and related, among others, assigned to my region. Initiation of clinical sites, routine monitoring for protocol adherence, regulatory document compliance, case report form review, collating and resolving queries on data from allocated clinical trials.
2004 to 2006. Senior Medical Consultant / Medical Science Liaison in the U.S.A. and Europe.
S&P Pharmatest Management GmbH.
Berlin, Germany, Plantation, Florida and Township of Washington, New Jersey
Responsible in the U.S.A. territory for the continued Clinical Research-Trials expansion and business development, including multi therapeutic monitoring. Experience with health outcomes research.
Responsible in establishing and sustaining clientele relationships for S&P Pharmatest, one of the longest established and specialized Clinical Research Organizations, operating in Central and Eastern Europe. Performed site monitoring duties, case report form review and queries.
2003 to 2005. Medical Director
Alternative/ Complementary/ Preventive/ Integrative Medicine Center
Healthy Impacts Wellness Center
Township of Washington, New Jersey
Responsible for the medical direction, project management, construction and development of own preventive, natural integrative, alternative and complementary medicine wellness center project, designed for the total wellness of the mind, body and soul. Therapies include numerous alternative natural medicine disciplines, such as Nutrition, Natural Remedies and Products, Massage Therapy, Iridology, Enzymes, Clinical Hypnosis, Body Work, Clinical Aromatherapy, Reflexology, Sexual and Marital Relationship Therapy, Dance Therapy, Music Therapy, General Counseling and Cranio-Sacral Therapy, among others. Specialty in Music Therapy with emphasis on Cuban and Afro-Cuban percussion rhythms and genres for children with Autism and behavioral/developmental disabilities.
2002 to 2002. Clinical Research Study Coordinator-Manager (Contract)
Mid-Atlantic Clinical Studies, Inc., West Caldwell, New Jersey
6. Responsible for management of all clinical trials conducted at this facility relating to: Hypertension, Otitis Media in Children, Chronic Bronchitis, Community Acquired Pneumonia, Diabetes, Amputation Prevention, Oncology, CNS, Erectile Dysfunction and other clinical studies, as offered/approved to the site.
Research Coordinator / Manager of the Following Studies:
7. A double-blind, randomized, placebo and active controlled, parallel group. Dose-finding study to evaluate the efficacy and safety of once daily oral administration of 5 mg.,10 mg., 25 mg., and 50 mg., of Drug X for 8 weeks in patients with mild to Moderate Essential Hypertension. (Phase II-b)
• A multi-center, double blind, randomized study to evaluate the effects of Drug X
and the combination of Drug X and Drug Y on Blood Pressure, (ambulatory and
standard cuff) and on selected biochemical markers of Endothelial Function,
Safety / Tolerability. (Phase III)
8. A randomized, investigator-blinded, multi-center, comparative study of Drug X versus high-dose Drug Y, in the treatment of Recurrent Otitis Media and Acute Otitis Media treatment failures in children. (Phase III)
| |A randomized, multi-center, blinded study of the efficacy and safety of high-dose, (750 mg.), short-course, (3-5 days) Drug X therapy in |
| |Uncomplicated and Complicated Acute Bacterial Exacerbation of Chronic Bronchitis. (Phase III-b) |
| |A comparative study of the safety and efficacy of three oral doses of Drug X for the treatment of subjects with Community Acquired Pneumonia. |
| |(Phase II-b) |
| |A double-blind, randomized comparison study of the long term, (2-year), safety and efficacy of Drug X or Drug Y in subjects with Type 2 Diabetes |
| |naïve to pharmacological therapy, (Phase IV) |
| |A double-blind, randomized, placebo-controlled study to assess the efficacy and safety of Drug X for the treatment of Critical Leg Ischemia. (Phase|
| |III) |
| |A randomized, double-blind, multi-center, two-arm study to investigate the safety and tolerability of flexible doses of Drug X or Drug Y given on |
| |demand in African American, Hispanic and Caucasian males with Erectile Dysfunction. (Phase III-b) |
| | |
| |1998-2001. Clinical Research Study Coordinator |
| |Florham Park Associates, Florham Park, New Jersey |
| | |
| |Teqces Trial: A prospective evaluation of the effectiveness of |
| |Tequin (Gatifloxacin) in Community Acquired Pneumonia and Acute Sinusitis |
| |Logic Trial: A comparison of effectiveness and side effects between |
| |Norvasc, (Amlodipine), and Lotrel (Amlodipine/Benzepril) |
| |Evident Trial: A retrospective analysis of effectiveness and Lipid |
| |Profile Changes between Actos, (Pioglitazone) and Avandia, (Rosiglitazone) |
| |Various studies in Hypertension, Diabetes and others |
| | |
| |2000-2000. Portamedic/Mobile Paramedic Examiner (Part Time) |
| |New York City, New York |
| | |
| |Provided medical examinations to active and future insurance policy holders/prospects/candidates |
| |1987-2000. Senior REMAC E.M.T./ PARAMEDIC (Part Time) |
| |New York City Fire Department, Bureau of Emergency Medical Services |
| |New York City Health & Hospitals Corporation, New York City, New York |
| | |
| |Responded to multiple scenes of diverse life-threatening emergencies. Provided |
| |pre-hospital emergency medical care, using advanced life support protocols and |
| |treatment modalities/procedures with efforts to improve patients’ medical/traumatic conditions, at the scene and while en route to the emergency |
| |rooms of the logistically designated area hospitals |
| | |
| |1986-1987. Emergency Medical Technician, (EMS), Emergency Medical Services |
| |Jersey City Medical Center, Jersey City, New Jersey |
| | |
| |Responded to multiple scenes of diverse life-threatening emergencies. Provided |
| |pre-hospital emergency medical care using basic life support protocols and |
| |treatment modalities/procedures with efforts to improve patients’ medical and traumatic conditions, at the scene and while en route to the |
| |emergency rooms of the logistically designated area hospitals |
| |1985-1986. Emergency Room Nursing Assistant |
| |Elizabeth General Hospital, Elizabeth, New Jersey |
| | |
| |Assisted physicians and nurses in the emergency room, taking patient’s data, vital signs, |
| |history, drawing blood (phlebotomy), administering intravenous fluids, cardiac monitoring, |
| |performing EKG’s and helping out, in general, with procedures, staff duties and patients’ needs |
| | |
| | |
| |1977-1980. Mobile Paramedic Examiner / Various Paramedical Companies |
| |New Jersey and New York City |
| | |
| |Provided medical examinations to active and future insurance policy holders/prospects/candidates |
| | |
| |1978-1982. Pharmaceutical Sales Representative (Part Time) |
| |Dominican Republic |
| | |
| |During my medical school years, as a general specialty Pharmaceutical Sales Representative, |
| |( For the Dominican Republic, Caribbean, North American and European markets ) |
| |Special Programs, Government/Industry Concessions, Clauses, Scheduling, Incentives and Employment considerations were provided and extended to |
| |interested candidates registered and enrolled as students in medical, dental and veterinary schools |
| | |
| |• Ciba-Geigy Pharmaceuticals. June 1978 to June 1979 |
| |• Dupont Pharmaceuticals. June 1979 to June 1980 |
| |• Glaxo-Wellcome Pharmaceuticals. June 1980 to June 1981 |
| |• Hoechst Pharmaceuticals. June 1981 to June 1982 |
| | |
| |1978-1984. Clinical Research Associate, Study Coordinator, Manager. Various |
| |National / International laboratories, pharmaceutical, and medical device companies. |
| |Dominican Republic |
| | |
| |During my medical school years, as a Clinical Research Associate/Study Coordinator/Monitor, scientific and investigative clinical research at |
| |different levels, trials and phases, (l to lV), on various, multiple general therapeutic areas, and specialties: CNS, Diabetes, Hematology, |
| |Immunology, Rheumatology-Arthritis, Neurology, Pain Management, (Neck, Back, Limbs, Joints, Nerves, and General Musculo-Skeletal), Infectious |
| |Diseases, Antibiotics, Antifungals, Antiparasitics, Ophtalmology,(Conjunctivitis, Glaucoma, Diabetic Retinopathy, Cataracts), Osteoporosis, |
| |Nephrology, Urology, HIV, Dermatology, Respiratory, Cardiology, Cardiovascular, CHF, HTN, Psychiatry/Psychotropics, Oncology, Medical Devices, |
| |(AED’s, ET and EOA tubes, oropharyngeal airways, limbs’ prosthesis, nasogastric tubes, catheters, syringes, stents). |
| | |
| |(For the Dominican Republic, Caribbean, North American and European markets). |
| |Special Programs, Government/Industry Concessions, Clauses, Scheduling, Incentives and Employment considerations were provided and extended to |
| |interested candidates registered |
| |and enrolled as students in medical, dental and veterinary schools |
| | |
| |• Laboratorios Cientificos, S.A. September 1978 to April 1979 |
| |• Europe-Caribe Laboratories C. por A. September 1979 to April 1981 |
| |• Laboratorios De Investigaciones |
| |Farmaceuticas, S.A. September 1981 to April 1984 |
| |1976-1977. Emergency Medical Technician and Mobile Intensive Care Unit Paramedic |
| |Emergency Medical Services, City of Elizabeth, New Jersey |
| | |
| |Began working as an Emergency Medical Technician (E.M.T.) and within a short period of |
| |time, selected to participate in 3rd Class of Paramedics in training under the “Pilot Program” of the State of New Jersey, thus becoming the first |
| |Hispanic Mobile Intensive Care Unit |
| |Paramedic (M.I.C.U.P.) in the State of New Jersey with License #0075, (75th Paramedic trained in the state of New Jersey and also the 1st Hispanic |
| |one) |
| |1975-1976. Emergency Medical Technician |
| |Paterson Fire Department, Ambulance Division, Paterson, New Jersey |
| | |
| |EMT duties and responsibilities, same as previously described above. |
| | |
| |1974-1975. Cardio-Pulmonary Resuscitation, (CPR), First Aid and |
| |Electrocardiography Instructor, (AHA and ARC) |
| |Hudson County Vocational & Educational Schools, North Bergen, New Jersey |
CLINICAL RESEARCH OVERVIEW
Clinical Research Management of Multiple Clinical Research Sites for Clinical Research Organizations, (CRO’s), Pharmaceutical and Bio-Technological Industries.
General Responsibilities for: Project Manager / Sr. Clinical Research Associate / Clinical Research Study Coordinator / Manager / Clinical Research Associate.
9. Combined 15 years in Clinical Research with over 10 years of on site/field monitoring and independent monitoring experience.
10. Conducts pre-study site visits to evaluate adequacy of site, Investigator and research staff in accordance with Sponsor protocols.
11. Training, supervising, managing clinical research staff according to SOP's, GCP’s, ICH Guidelines and FDA regulations.
12. Conducts ongoing monitoring visits to assigned investigational sites, in accordance with Sponsor protocols, SOP's, GCP's, ICH Guidelines and FDA regulations to verify that the rights and well being of human subjects are protected.
13. Corroborating that the reported data is accurate, complete and verifiable from source documents.
14. Verifying both individual patient and overall drug accountability, reviewing all of the appropriate source documents, such as subject research records, subject medical charts, etc., and reviewing documents in Investigator site files.
15. Provides on-site orientation of Investigators and other site personnel.
16. Reviewing all related study documents for completeness and accuracy.
17. Endeavors to ensure that study documentation is completely and properly maintained in accordance with Sponsor protocols, SOP's, GCP's, ICH Guidelines and FDA regulations.
18. Prepares and submits timely appropriate monitoring forms and site visit reports in accordance with SOP's and the Project Operations Manual.
19. Monitors Investigator compliance for the preparation and reporting of adverse events and serious adverse events reports for timely appropriate submissions to sponsor and IRB.
20. Experienced with hospital charts.
21. Compliance Control and Quality Assurance.
22. Assisting in the management of clinical drug trials, including generics, protocol/case report form development, investigating collection of clinical study documentation, drug safety, AE’s and SAE’s.
23. Participates in Project Team meetings, offering suggestions, leading to timely and successful placement and completion of studies.
24. Communicates effectively with members of the Project Team, Regional Field Manager, Senior Director of Clinical Research Operations, Pharmaceutical Services associates, Investigators, and site personnel.
25. Conducting periodic audits of site files.
26. Ensuring proper storage, dispensation and accountability of clinical trial supplies and study drugs.
27. Pharmaco-vigilance.
28. Preparing serious adverse event reports and adverse event reports.
29. Project Management. Reporting information to sponsors.
30. Accepting direction and guidance on assigned projects from respective Regional Field Manager, Senior Director of Clinical Research Operations, Project Leader and Director of Project Management.
31. Assisting in the development of patient educational materials.
• Management of clinical protocols within the framework of GCP’s and FDA regulatory guidance.
• Experienced with Medra coding, Argus, (Relys) coding and other software
• Experienced with RECIST criteria, (Oncology).
• Reviewing/checking study documents according to procedures/clinical study types, (Phases I-IV).
• Responsible for overall site management, conducting initiation, interim, and close-out visits.
32. Monitoring and collecting clinical trials data; coordination of designed trials; preparation of written reports; studying and tracking of documents in a timely, concise and accurate manner.
33. Experienced with JCAHO, HIPPA, OSHA.
34. Provides for a timely and accurate submission of time, expense, monitoring reports, schedules and other miscellaneous requests, as per SOP's and the Project Operations Manual.
35. Set-up, maintain and distribute enrollment or special project reports.
36. Attend Investigators Meetings where appropriate.
37. Prepare draft Team Meeting Minutes.
38. Contribute to the completion of Project Specific Instructions.
39. Prepare Study Guide and/or any other forms completion instructions.
40. Perform review of Case Report Form data, (CRF's) with appropriate resolutions and follow-ups. Coordinate PRA specific study implementation activities with the Project Leader.
41. Participate in the design of the data review plan, in the oversight of data review and in the data consistency among PRA's.
42. As assigned, track, review, and report to the Team on the status of CRF progress.
43. Implement data query process.
44. Track and review Investigator financial payment information.
45. Participate in CRF data review meetings.
46. As necessary, assist the Project Leader in review and tracking of required study related regulatory documents.
47. Electronically track serious adverse events.
48. Interact with Data Management personnel on data projects to assure a clean final data tape/report or other transmissions produced and delivered to the Sponsor.
49. Participate in Team meetings by reporting CRF completion issues and problems.
50. Assist in the preparation of study related documentation.
51. Provide health education and guidance when necessary and/or assigned.
52. Important and significant involvement in the recruiting, design, and/or implementation of inpatient SOP's, Guidelines, Process Flows, Infrastructures and Systems for assigned private medical practices, hospitals, and institutions conducting inpatient trials.
53. Other responsibilities as assigned by Team, Manager, Project Leader and/or Principal Investigators.
TRAINING AND CERTIFICATES
54. American Board of Hypnotherapy-Presently, Certified and Registered as a Clinical Hypnotherapist
55. Institute of the National Association of Certified Natural Health Professionals-Certified in Iridology, Body Work, Body Systems, Clinical Aromatherapy, Enzymes, Cranio Sacral Therapy, Nutrition and Practicum The Praxis Series, Professional Assessments for Beginning Teachers-Certified in Spanish Content Knowledge, (0191)
56. Attendance to multiple continuous medical education (C.M.E.) conferences, workshops, seminars and training in a variety of medical, pharmaceutical and clinical research related subjects
MEDICAL ASSOCIATIONS AND MEMBERSHIPS
57. Medical Director Hispanic Division Worldwide Global Institute for Alternative Medicine, (GIFAM), and the Global College of Natural Medicine (GCNM)
58. Medical editorial writer on Health/Wellness and Complementary/Alternative Medicine issues and Spanish-American Newspapers.
59. The National Association of Certified Natural Health Professionals, (NACNHP) (2003-Present)
60. Program Director of the New Jersey Chapter, (NJNHP), (A non-profit organization)
61. Spanish-American Naturopathic Association, (SANA). (2003-Present). Founder and President of the Organization, (a non-profit organization).
62. New Jersey Department of Health and Senior Services, (1999-2000). Medical consultant for the Latino Health Advisory Committee and The Office of Minority Health. Participated in the Summit Recommendations Report The Health of Minorities in New Jersey Part Two, “The Latino Experience”, finalized in October 2000. state.nj.us/health/commiss/omh/latino2000.pdf
63. Hispanic Association of Health Professionals, Incorporated (AHPSI) (1999 to 2000) Vice President and Public Relations Officer
64. Spanish-American Medical Association (SAMA) (1985 to 2000)
65. Medical Association of Doctors, (MAD) (1990’s) President, Vice President
66. Parents’ League of American Students Abroad, (PLASMA) (1980’s)
67. National Registry of Paramedics (1970’s to 1980s)
68. National Registry of Emergency Medical Technicians, (1979’s to 1980’s)
69. National Association of Paramedics (1970s to 1980s)
OTHER MEDICAL PROFESSIONAL AREAS OF PARTICIPATION
70. Strong professional project management in business, educational and marketing with numerous important and relevant relationships nationally and internationally, including, but not limited to USA, Europe, Ibero-America, Central America, South America, the Caribbean and Puerto Rico.
71. Advocate of Natural/Alternative/Preventive/Integrative Medicine
72. Fully Bilingual-Spanish/English. Computer Literate/Internet Savvy. Bilingual Educator, Instructor, Consultant, Counselor, Recruiter, Credential Specialist, Proofreader, Medical Sciences Liaison, and Medical Translator
73. Experienced in Medical Communications
74. Liaison in Public Affairs, Medical Affairs and Public Relations
75. Activist, Leader, Event Planner and Organizer
76. Experienced in Pharmaceutical, Medical, Surgical and Hospital Sales and Marketing
77. Experienced in Family Planning, Social Services and Social Work with children, adolescents, adults and the elderly
Experienced with Developmental Disabilities, Mental-Health, HIV and Substance Abus
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.