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Medical Affairs Ophthalmology Consultant with Expertise in Clinical Trial Protocols PO BOX 5092 Irvine, CA 92616 mercedestribin@yahoo.com Telephone: (949) 230-2962
SUMMARY OF QUALIFICATIONS
Five years experienced in development of: Clinical Trial Protocols, Product Registration, IDE, IND, 510K, Technical Files; CE Mark; Clinical Trials Data Interpretation, and Study Subject Evaluation. 17+ years of experience acting as a medical liaison with colleagues, medical community, pharmaceutical industry, and general public. 13+ years o f experience in clinical and surgical ophthalmology, specializing in retina surgery and laser treatments. Strong analytical, organizational and communication skills. Extensive knowledge of federal and international regulations, knowledge and interpretation regarding medical devices, pharmaceutical products and clinical trials. Computer literacy. Fluent in Spanish, Italian and English. Able to travel nationally and internationally and to be relocated.
Main Responsibilities: Care for and monitor all the real estate properties and execute acts of administration and maintenance, in accordance with the regulations and restrictions set out for the States of California and Arizona (USA). Recruitment, supervision, management and payment of suppliers, contractors, construction, cleaning and maintenance personnel. Attendance at courses, conferences and continuing education forums related to real estate management, relevant rules of construction and maintenance and restoration of property, imposed by private or government entities in the states of California and Arizona. Create, edit, update internal apartment`s rules and regulations. Development and implementation of bilingual leases. Outstanding achievements: 1. Duplication in collection of income production from January 2009 to January 2013. 2. Decreased debt portfolio by 80% to date. 3. Standardization of contracts and implementation of rental agreement rules according to local and federal laws by 100%. 4. Improvement and modernization of housing units by 80% according to the provision of capital.
Scientific Consultant
Albert Rego, Ph.D scientific consultant October 2004 July 2008 (3 years 10 months) Mission Viejo, California Main Responsibilities: Developed, designed and obtained approval for Clinical Trial Protocols according to GCP (Good Clinical Practices) and GLP (Good Laboratory Practices), using scientific methods and research design with emphasis on Human Safety Issues. Broad experience in Protocol design and Product Registration, 510K,Technical Files and CE mark in the following areas: Bariatric surgery, Ophthalmology, Dermatology and Plastic Surgery, Gynecology, Surgery, disposable devices and Naturopathic products. Prepare quality manuals and Standard Pharmaceutical and Medical Device clients. Operating Procedures (SOP) for
Interacted directly with FDA Authorities, Sponsors, Principal Investigators, IRBs, CROs, Biostatisticians and Monitors
Outstanding Achievements: 1. Increased principal investigators interest in clinical studies, becoming more active an effective 2. FDA compliance deadlines granted 100%
3. Creating a multidisciplinary team of medical researchers, regulators, engineers and biostatistics in order to achieve approval of protocols for clinical trials on a much shorter time. 4. Active participation in meetings with pharmaceutical companies and principal investigators. (KOL)
Scientific Consultant
Jondel Enterprises January 2000 July 2004 (4 years 7 months) / Huntington Park, California Main responsibilities: Quality system construction and development. Prepared SOP manuals and quality assurance documents in compliance with FDA. Worked and communicated effectively with doctors and managers to improve patient care. Resourcefully seeks information to recommend and defend appropriate scientific opinions Outstanding Achievements: 1. Improvement in the relationship and communication between the group of dentists and staff. 2. Implemented (SOP).
Ophthalmologist
Lions Club Clinic January 1990 April 1997 (7 years 4 months) / Barranquilla, Colombia, South America Main Responsibilities: Improved clinical patient satisfaction and physicians performance by implementing CAPA system during surgical and postoperative care. Strong emphasis in diabetic patients with eye related diseases, working closely with Internal Medicine and Nutrition Departments. Provided clinical, surgical treatment and specialized ophthalmic procedures to lowincome patients.
Outstanding achievements: 1. Created Retina Clinic Department for evaluation of patients attending the clinic with retina diseases. 2. Increased volume of retina surgeries and laser treatments, which did not exist previously in the Lions Club Clinic. Previously, patients with retina diseases were referred to other institutions.
Ophthalmology Professor
Universidad del Norte, Barranquilla Colombia January 1991 December 1996 (6 years) / Barranquilla, Colombia, South America Main Responsibilities: Provided ophthalmic educational and technical in-service training to medical students. Acted as a scientific expert between Medical Affairs and the medical community through the dissemination, clarification and education of scientific data. Managed the scientific needs of national and regional key opinion leaders (KOLs) by establishing long-term strategic relationships with key, influential physicians/investigators and with major medical associations and academic centers.
Main Responsibilities: Strong emphasis in diabetic patients with eye related diseases, working closely with Endocrinology and Nutrition Departments as a medical Liaison. Provided instruction to ophthalmologists and students in retina angiography, retina surgery, ophthalmic laser procedures and echography. Provided clinical, surgical treatment and specialized ophthalmic procedures. Outstanding achievements: 1. Created Retina Clinic Department for diagnosis, evaluation and appropriate referral to specialized treatment centers. 2. Reduced unnecessary referral of patients with diseases not treatable with laser surgery to specialized treatment centers. 3. Implemented education of medical and paramedical personnel, in this way reducing cost to the institution involving the transfer of retina diseases patients to affiliated centers. 4. Implemented mandatory evaluation of the retina in 100% of patients who consulted to the Ophthalmology Service and thereby increasing early detection of retinal pathology not previously detected. 5. Implemented education for medical and paramedical personal for other Departments as General Medicine, Internal Medicine, Endocrinology, Neurology and Pediatric in charge of integrated management of diabetic patients for early detection and treatment of diabetic retinopathy.
ASSOCIATIONS
OCRA member since 2006 AOA member since 2009
LICENCES
Doctor in Medicine, Colombia Ophthalmologist, MD; Colombia Certified Retina Angiographer and Ocular Echographer; Colombia Gemologist; USA
AWARDS
Colegial de Numero de Medicina. Colegio Mayor de Nuestra Senora Del Rosario. Cum Laude. Treasurer. Sociedad Colombiana de Oftalmologia. Barranquilla Chapter. Colombia, South America. Master Gemologist Certificate Cum Laude. College for Appraisers.
EDUCATION
2008 2007 2006 2005 2005 1999 1989 1988 1984 1983 US RAC Study Group Combination Product UCI Clinical Trials Internship Marketing Principles Medical Product Development Chinese Medicine Principles Ocular Echography Certificate Degree in Ophthalmology Certified Retina Angiographer Doctorate in Medicine OCRA Training Certificate, CA University of California, Irvine, CA University of California, Irvine, CA University of California, Irvine, CA University of California, Irvine, CA South Baylo University, CA Hospital San Juan de Dios, Colombia Universidad del Rosario, Colombia Hospital San Jose de Bogota, Colombia Universidad del Rosario, Bogota, Colombia
WORK REFERENCES
Dr. Hernando Henriquez Henriquez H.S.H. Legal Solutions Past Director of Social Security Clinic, Via 40 Unit, Barranquilla, Colombia. Cell: 316 8336281 Barranquilla, Colombia. E-mail address: henriquezsolucion@hotmail.com
Dr. Mathias Fobi President Elect of the International Federation for Surgery of Obesity, President of the California Chapter of the American Society for Bariatric Surgery, immediate past President of the American Society of Metabolic and Bariatric Surgery Foundation 432 E 10th St, Long Beach, CA 90813 Phone: +1 562-491-7935 Email address: fobimal@aol.com fobimal@gmail.com Dr. Alfred Shihata President of Fem-Cap, Inc. 450 4th Ave Suite 305 Chula Vista, CA 9191 Phone: (619) 422-6158 E-mail address: alfred@fem.cap.com
PERSONAL REFERENCES
Dr. Francisco Jose Rodriguez Alvira Scientific Director. Fundacion Oftalmologica Nacional. Cll 50 No 13-50 Bogota, Colombia Phone (031) 345-1753 Email address: fjrodriguez@fon.org.co
Dr. Alvaro Rodriguez Gonzales General Director and Founder. Fundacion Oftalmologica Nacional. Cll 50 No 13-50 Bogota, Colombia Phone : (031) 345-1788 Email address: arodriguez@fon.org.co