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: and
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 www.cnhp.org
· 1978-1984. M.D., (Doctor of Medicine) – Universidad Central Del Este, School of Medicine, San Pedro de Macoris, Dominican Republic
· 1974-1977. Essex County College, Newark, NJ – Completed pre-medicine requirements
· 1973-1974. Rutgers University - Newark, NJ - Completed pre-medicine requirements
· Fully Bilingual, (Spanish-English).
·
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, www.upledger.com 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
· 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:
· 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)
· 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 YorkResponded 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 JerseyResponded 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 JerseyAssisted 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 CityProvided medical examinations to active and future insurance policy holders/prospects/candidates
1978-1982. Pharmaceutical Sales Representative (Part Time)
Dominican RepublicDuring 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.
· Combined 15 years in Clinical Research with over 10 years of on site/field monitoring and independent monitoring experience.
· Conducts pre-study site visits to evaluate adequacy of site, Investigator and research staff in accordance with Sponsor protocols.
· Training, supervising, managing clinical research staff according to SOP's, GCP’s, ICH Guidelines and FDA regulations.
· 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.
· Corroborating that the reported data is accurate, complete and verifiable from source documents.
· 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.
· Provides on-site orientation of Investigators and other site personnel.
· Reviewing all related study documents for completeness and accuracy.
· 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.
· Prepares and submits timely appropriate monitoring forms and site visit reports in accordance with SOP's and the Project Operations Manual.
· Monitors Investigator compliance for the preparation and reporting of adverse events and serious adverse events reports for timely appropriate submissions to sponsor and IRB.
· Experienced with hospital charts.
· Compliance Control and Quality Assurance.
· 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.
· Participates in Project Team meetings, offering suggestions, leading to timely and successful placement and completion of studies.
· Communicates effectively with members of the Project Team, Regional Field Manager, Senior Director of Clinical Research Operations, Pharmaceutical Services associates, Investigators, and site personnel.
· Conducting periodic audits of site files.
· Ensuring proper storage, dispensation and accountability of clinical trial supplies and study drugs.
· Pharmaco-vigilance.
· Preparing serious adverse event reports and adverse event reports.
· Project Management. Reporting information to sponsors.