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medical research professional, research assistant, research coordinator, clinical research associate, regulatory coordinator with 12 years experience looking for a Middle Management position.
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medical research professional or research assistant or research
medical research professional, research assistant, research coordinator, clinical research associate, regulatory coordinator with 12 years experience looking for a Middle Management position.
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medical research professional, research assistant, research coordinator, clinical research associate, regulatory coordinator with 12 years experience looking for a Middle Management position.
Copyright:
Attribution Non-Commercial (BY-NC)
Formati disponibili
Scarica in formato TXT, PDF, TXT o leggi online su Scribd
Lyndhurst, OH 44124 440-398-6048 sha78da4@westpost.net CAREER SUMMARY Results-oriented Medical Research Professional with a unique combination of clinical and analytical, skills honed through more than 12 years of extensive experience in medical research. Establish timelines and monitor project goals and objectives, and coordinate with internal teams to ensure both timeliness and accuracy of studies. Manage data and medical documentation, and oversee the collection of critical study documents. Strong research and analytical skills and needs assessment capabilities result in the identification and implementation of strategies that support clinical trials. Knowledge in OHRP and FDA guidelines governing human subjects' research. Specific expertise in the following: * Clinical Trials / Research Management * Protocols / Clinical Studies / Compliance * Creative Problem Solving / Critical Thinking * Project Management * Multi-Tasking * Organized / Detail Oriented * Team Player * Good Communication Skills * Bilingual English and Croatian * MS Office PROFESSIONAL EXPERIENCE Cleveland Clinic, Cleveland, OH 2008 - 2010 One of America's top hospitals and medical research center. Research Coordinator, Solid Tumor Oncology 2010 Responsible for Institutional Review Board (IRB) submissions and approvals, SAE's-safety reporting, maintenance of regulatory documentation, building study calendar and budget, assistance with the study budget / contract. * Obtained contract extension and approvals for research projects. * Communicated with Sponsor Organizations relating to the research projects. Research Coordinator, Digestive Disease Institute 2008 - 2010 Worked on research protocols, documentation required to obtain study approval. * Worked on the study of the new Endoscopic Camera Pill and regulatory documentation. * Communicated with the sponsor / monitor, assisted with the budget, prepared study materials and organized site initiation visit to educate staff about the study * Assisted with screening / enrollment, consented subjects, and maintained study documentation. University Hospitals, Cleveland, OH 2000 - 2007 Hospital and medical research center. Coordinator, Office of Institutional Review 2002 - 2007 Reviewed research project documentation submitted for approval to the Institutional Review Board. Coordinated hundreds of submitted projects annually. * Acted as the primary liaison between the IRB and Primary Investigators. Collaborated in developing protocols, consent forms, and adverse event forms in order to ensure responsible conduct of research, as set down by the IRB and other regulatory agencies. * Obtained additional or missing information, and provided individualized assistance to researchers when necessary. Clinical Data Manager 2000 - 2002 Compiled patient information from various sources in order to ensure that information was uniform and in line with guidelines set up by the United Network for Organ Sharing and Cardiac Transplant Research Database. * Updated and maintained the database for Heart Failure / Transplant Center. * Collaborated with staff from various institutions on collection and update of patient transplant data and entered said data into database. * Designed Excel spreadsheets in order to store and collect data for various research projects. * Worked as part of a team to develop statistical analysis and interpret the data. Case Western Reserve University, Cleveland, OH 1997 - 1999 One of the nation's top universities and an independent, leading research institute. Research Assistant Performed studies on central regulations of cholinergic outflow to the airways and urinary system by using expression of c-fos gene encoded protein and retrograde transneuronal labeling with pseudorabies virus. * Implemented immunohistochemistry staining on brain tissue slices. * Performed small animal surgery including intra-cardio perfusion and brain and spinal cord sectioning. * Contracted with outside organization and inside departments in business and academic settings for logistic support of research projects based on needs and budget. * Collected data, images, and results from experiments in order to present the findings to the scientific community through publications, presentations, and posters. EDUCATION Doctorate of Medicine (M.D.), School of Medicine, University of Zagreb, Croatia, 1990 Internship Training, University Hospital Sestre Milosrdnice, Zagreb, Croatia, 1990 - 1991 PROFESSIONAL ASSOCIATIONS Association for Clinical Research Professionals Public Responsibility in Medicine and Research / Applied Research Ethics National Association SoCRA, currently active membership LICENSES AND CERTIFICATES Human Subject Research Protection Certificate IRB Professional Certificate ECFMG Certificate Croatian Medical License Medical Doctor Diploma VOLUNTEER EXPERIENCE MetroHealth Medical Center, Cleveland, OH 1999 Worked in the Department of Pediatrics as an observer. Red Cross, Zagreb, Croatia 1991 - 1992 Instructed basic life support technique and organized civil protection units. PUBLICATIONS Peer Reviewed Scientific Papers: Principe-Rodriquez K., Strohl K.P., Hadziefendic S., Pina I.L. (2005) Sleep symptoms and clinical markers of illness in patients with heart failure. Sleep Breath 9:(3), 127 - 133. Belegu R., Hadziefendic S., Dreshaj I.A., Haxhiu M.A., Martin R.J. (1999) CO2-induced fos expression in medullary neurons during early development. Respiration Physiology 117, 13 - 28. Grill W.M., Erokwu B., Hadziefendic S., Haxhiu M.A. (1999) Extended survival time following pseudorabies virus injection labels the suprapontine neuronal network controlling the bladder and urethra in the rat. Neuroscience Letters 270:(2), 63 - 66. Hadziefendic S., Haxhiu M.A. (1999) CNS innervation of vagal preganglionic neurons controlling peripheral airways: a transneuronal labeling study using pseudorabies virus. Journal of the Autonomic Nervous System 76, 135 - 145. Grill W.M., Wang B., Hadziefendic S., Haxhiu M.A. (1998) Identification of the spinal neuronal network involved in coordination of micturition in the male cat. Brain Research 796, 150 - 160. Abstracts: Hadziefendic S., Erokwu B., Haxhiu M.A. (1999) CNS network innervating laryngeal muscles. Faseb Journal 13:(4) A492. Haxhiu M.A., Erokwu B., Waldbaum S., Hadziefendic S. (1999) Projections from the amygdaloid complex and the hippocampal formation (HP) to the Pre-Botzinger complex (PBC). Soc. Neuroscience 25:(1) 279. Grill W.M., Hadziefendic S., Erokwu B., Haxhiu M.A. (1998) Co-localization of parvalbumin and c-fos in sacral spinal neurons involved in regulation of micturition. Soc. Neuroscience 24:(2) 1618. Hadziefendic S., Erokwu B., Liu S.J., Haxhiu M.A. (1997) The CNS network controlling intrapulmonary airways. American Journal of Respiratory and Critical Care Medicine 157, A722. Research Data Presentation: Experimental Biology, Washington DC, 1999. International Conference, Respiratory and Critical Care Medicine, Chicago IL, 1998.