Cell Phone Number: 214-566-4603. E-mail: jd64569c@westpost.net CITIZENSHIP: U.S.A OBJECTIVE: A Ph.D. Life Scientist seeking a position with top level pharmaceutic al industry, prestigious medical research center, CRO or FDA to leverage academi c, clinical research professional training, discovery research and experience to drive achievement of program goals. SUMMARY: * Possess sound scientific knowledge, training in new drug discovery process, c linical research project planning, implementation, monitoring and report writing . * Possess thorough knowledge of GCP, ICH/E-6, and FDA regulations * Serve as IRB Chairman, review clinical trials for scientific merit and protect ion of human subjects (21 CFR 50; 21 CFR 56; 45 CFR 46); FDA/GCP and ICH/GCP. * Possess CLIA-certified, AABB-certified, CAP-approved clinical & Molecular Diag nostics/DNA Identity Laboratory Director experience; secured competitive grant f unding in excess of $1,310,000.00; 35 scientific publications and abstracts. * Strong organizational skills, self-motivated, assertive, able to work independ ently or as part of a team. EDUCATION/TRAINING Wayne State University, Detroit Michigan, USA Ph.D. 1974-1980 Biochemistry Wayne State University. Management Training CRA certificate 2007-2008 Clinical Resear ch Professional Training APPOINTMENTS 2007-2010 Compliance Auditor (Consultant) Dallas Methodist Health System 2007- 2008 Interim Chairman & Consultant, Dallas Methodist Health System (6 mont hs) 2006-2007 Senior Scientist, Department of Molecular and Cellular Biology Univers ity of Texas at Dallas 2002-2005 Director, Genetic Services, Sickle Cell Disease Association of America , Dallas. 1994-2002 Clinical Laboratory Director, Sickle Cell Laboratory, Fort Worth, Texa s, CLIA ID # 45D0486179 1992-1997 Associate Director, DNA/Identity Laboratories, Department of Pathology , University of North Texas Health Science Center, Fort Worth, Texas. 1992-1997 Assistant Professor of Pathology, University of North Texas Health Sci ence Center, Fort Worth, AWARDS AND OTHER PROFESSIONAL ACTIVITIES 2005-2010 American Society for Advancement of Science-Member 1997 National Institutes of Health (NIH) Invited Grant reviewer: Gene therapy fo r sickle cell disease 1992-1997 American Association of Blood Banks DNA Laboratory Accreditation Inspe ctor; 1974-1980 African-American Graduate Fellow/African-American Institute 1974-1980 US Agency for International Development Fellow (AID) Selected Publications (Peer-reviewed Scientific Journals: 14 publications 20 abs tracts) 1. X. Yao, S. Kodeboyina, L. Liu, J. Dzandu, J. Sangerman, S. Ofori-Acquah, B. P ace Role of STAT3 and GATA-1 interactions in *-globin gene expression Experiment al Hematology, Volume 37, Issue 8, Pages 889-900, 2009 2. Dzandu, J.K., Role of Sialic Acid in Selective Silver Staining of Red Cell Gl ycophorins: Journal of Applied and Theoretical Electrophoresis. 1, 137-144, 1989 3. Dzandu, J.K., *Deh, ME., Baratt, D. and Wise, G.E. Detection of Erythrocyte Membrane Proteins, Sialoglycoproteins and Lipids in a Single Polyacrylamide gel Using a Novel Double Staining Technique. Proceedings of the National Academy of Sciences, U.S.A. 81, 1733-1737, 1984 Personal Statement Possess through training, experience and expertise to perform the role of Princi pal Investigator, Research team leader or Clinical Trial Manager in life science or clinical project management. Responsible for hypothesis-driven project desig ns, implementation and evaluation using GCP standards and SOPs to ensure subject safety, protocol adherence and production of valid study results for FDA IND an d NDA submissions. Validate or re-formulate relevant standard operating procedur es based on cross-cutting platforms; conduct discovery research; collect, analyz e and report project data and present conclusions in meaningful fashion to stake holders, including internal and external customers, regulatory agencies and prof essionals. Understand the development process for Drugs, Biologics, and Medical Devices. Maintain regulatory compliance with FDA submissions/approvals, ICH guid elines, GMP, GCP, CLIA, CAP and Quality Control and Quality Assurance Programs a s they relate to primary areas of company enterprise. Effective verbal and writt en communication skills aimed at optimizing performance at varying levels of com pany organization, operation and analysis. Able to simultaneously handle multipl e projects, prioritize work, supervise others and meet deadlines and pre-determi ned benchmarks. Anticipate project related expected and unexpected adverse event s. Develop, implement and evaluate contingency plans to mitigate expected advers e events. Highly skilled in development, implementation and follow-up of correct ive action plans Maintain cognitive and operational flexibility in functional ar eas to develop effective time-lined solutions to unexpected difficulties before they become obstacles to project progress. Possess computer skills including, Mi crosoft word suite, and statistical software such as SPSS. Research Support 2005-2008 Health Resources and Services Administration, Child and Maternal Healt h (HRSA) * Grant award: $555,000.00-Dr. Dzandu, Principal Investigator 2003-2005 Health Resources and Services Administration, Child and Maternal Healt h (HRSA) * Grant award: $375,000.00-Dr. Dzandu, Principal Investigator 2002-2003 Health Resources and Services Administration, Child and Maternal Healt h (HRSA) * Grant award: $185,000.00-Dr. Dzandu, Principal Investigator 2001-2002 Texas Department of Health Innovative Grant * Grant award: $200,000.00-Dr. Dzandu, Principal Investigator Grants Submitted: SAMSAH: $1,500,500.00 (unfunded) Skills: Theoretical understanding and hands-on expertise with basic life and cli nical science research techniques to create new knowledge or find solutions to b iological problems of interest. These skills include proteomics, genomics, cell & molecular biology, biochemistry and immunology with special emphasis on discov ery research. Additional pertinent analytical techniques aimed at finding biomar kers include, electrophoresis (1 & 2 dimensions), IEF, western & southern blotti ng; RFLP, multiplex-PCR, nucleic acid-based diagnostics, HPLC, spectroscopy, cel l culture, transduction, electrophoretic mobility shift assays coupled with tand em protein mass spectroscopy (EMSA-MS/MS) and clinical laboratory testing. Resea rch grants proposal development for funding by governments, private and commerci al agencies with focus on biological research and health service programs. CLINICAL RESEARCH PROFESSIONAL TRAINING (140 HOURS) * The drug research and development process, Identifying and reporting of non-se rious and serious adverse events, principles of data management and query resolu tion, protocol development, case report form design, and informed consent writin g. * Good clinical practices 21 CFR 312 IND, 21 CFR 50 Protection of Human Subjects , 21 CFR 56 IRB, 45 CFR 46, 21 CFR 54 Financial Disclosure by Clinical Investiga tors. International Conference on Harmonization (E6) GCP Consolidated Guideline and (E2A) Clinical Safety Data Management. * Monitoring method and responsibilities: Systematic approach to monitoring, man aging essential documents and clinical trial materials. Selecting investigators and conducting pre-evaluation, study initiation, interim, and close out visits. Writing pre-visit letters, follow up letters, and site visit reports. Performed five mock site visits utilizing case studies and wrote example monitoring report s. Criteria for Course Completion: Comprehensive course examination, ICH/GCP regula tory examination, and performing a site monitoring visit identifying 80% of the deficiencies. References are available on request.