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Reynaldo S

Clinical Research - 12 Years of Experience - Near 78254

Occupation:

Clinical Research

Location:

San Antonio, TX

Education Level:

Associate

Will Relocate:

YES

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SUMMARY OF QUALIFICATIONS * Managed Phase I -IV and observational Clinical Research Trials for HIV/AIDS, HIV Vaccine trials, HIV and Hepatitis, Infectious Diseases, Hyperlipidemia, Diabetes, Renal CKD, Secondary Hyperparathyroidism, Vitamin D Deficiency, Diabetic Nephropathy, Allergies, Asthma, and Immunology, Hepatic therapeutical area, from HBV, HCV, Fatty Liver, Cirrhosis in the Liver, medical devices. * As an inhouse monitor 6 years experience with SMO's/Team Lead/Lead coordinator, understanding of IRB, ICH-GCP, FDA, HIPAA and related regulatory guidelines, follow and comply with Code of Federal Regulations for Human Subjects monitor relevant tracking system and trained team members * Independently conducted SIV, IMV and COV * Clinical Research Laboratory Management * Blood specimen collection Processing using different speeds of centrifuge both room temperature and refrigerated Validating * Identified and write out AE's/SAE's and submitted to the sponsor on a timely manner * Patient enrollment, compliance of the clinical site to regulatory requirements, accountability and dispensation of research drugs/devices, and the appropriate documentation of human subject involvement in a clinical research study, assist in project planning, etc * Knowledgeable on creating source documents, case report forms and other as required by protocols * Strong in eCRFs/EDC (Electronic Data Capture), Inform, LogPads/StudyPads, Digital ECGs, DataTrak (eClinical), Data trial, Expert EDC, etrials EDC, Oracle Clinical, Omnicom, Medidata Rave. Made sure that all data and queries were entered/resolved on a timely manner * Success in mentoring, motivating, training colleagues/team members * Successful history of initiating and executing ideas, programs, and processes that have had a direct positive effect on companies * Management-level, decision-maker accountable for setting priorities, planning, budgeting and meeting/ exceeding goals. * Strong communication skills, ability to speak 2 languages, organizational and leadership skills. Initiate and foster strong working relationships * Solid Project Management skills, including business, typing, editing, word processing, meeting planning, and coordination. * Proficient with several main line software programs (i.e., CTMS, Microsoft Word, Excel, PowerPoint, Access, HTML, Oracle/Browser, Java Script, WordPerfect) * Procurement, Budget/Cost Monitoring, Asset Mgmt., and Basic Administration, knowledge of material requisitioning, goods receipt. * Professional meeting planning (company launches, study recruitment presentations for doctors, Annual staff meetings etc.) * Self-motivated, reliable, competent, team player and self efficient Reynaldo Sosa CVof 15 -, double dummy, parallel group, active controlled trail to evaluate the antiviral efficacy of 400 mg QD nevirapine extended release formulation in comparison to 200 mg BID "Study Drug" immediate release in combination with Truvada in antiretroviral therapy na´ve HIV-1 infected patients. TMC114-TiDP31-C229 randomized, open-label trial to compare the efficacy, safety and tolerability of "Study Drug" QD versus DRV/rtv (600/100mg) BID in early treatment-experienced HIV-1 infected subjects. ADVENT protocol NP303-101 randomized, double-blind, parallel-group, placebo-controlled study to access the efficacy and Safety of "Study Drug" orally twice a daily for the treatment of HIV- associated Diarrhea. Smallpox protocol POX-MVA-011 a multicenter, open-label, controlled phase II study to evaluate safety and immunogenicity of "Study Drug" vaccine in wk Phase IV Randomized Double-Blind Multicenter Study of the Safety and Efficacy of Epzicom Versus Truvada Administered in Combination with "Study Drug" in

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