Project Management
Resume:
MIRJANA (MIRA) MARKOVICH-MITOV, BS, MS, PH.D.
tfe5qy@r.postjobfree.com
Skype: mirjamvirginia
Ph.D. in Pharmaceutical Science
Experienced Research Scientist with 10 years of experience in Biopharmaceutical, Biotech and Clinical research field, Member of Editorial Board for two Scientific Journals, Experienced in Statistical methods, and Author of Numbered Scientific papers, Elisa and Biomarkers Expert, Clinical Trials Professional, Communicative Expert, Skilled in US and European pharmacopeia, Leadership skills
Extensively degreed and practiced professional scientist with an internationally recognized aptitude in management, research and development. Exceptional skills garnered in 10 years of experience in ELISA research, and DNA testing, working on different clinical trials projects such as cardiovascular biomarkers, and designs scientific writing, project and timeline management, set up experience and supervision of staff members, proper laboratory material usage, SOP documentation, statistical data analysis, compliance, and report writing, as well as functioning of laboratory environment and management. Experienced in developing and managing of biopharmaceutical oncology, hematology, and cardiovascular research and development of therapeutics. Experienced in statistical support for scientific papers such as publications, presentations, and posters. Author of several scientific papers, and presentations.
AREAS OF EXPERTISE
• Supervisorial Aptitude
• ELISA, both quantitative and immunogenicity assays
• Project management
• Laboratory Practice
- Clinical Practice
• Microbiology techniques
• Microscopy Techniques
• Cardiac Biomarkers
• Clinical Study Design
• Clinical Trial Protocol
• Collaborative Work
• Instructional Development
• Communicative Ability
• Proficiency with Microsoft Word, Excel, PowerPoint as well as SPSS, SAS, and MedCalc Software tools
• Real World Database
• Data analysis, review and evaluation of results
• Meeting Procedure
• Public Relations
• Inventory Management
• Client Communications and presentations
• Writing of reports and protocols
• Skilled in US and European pharmacopeia
• Presentation experience
PROFESSIONAL EXPERIENCE
STRATFORD UNIVERSITY, Glen Allen, VA September 2010 – December 2011
Instructor (School of Health Science)
Performed central syllabi and course creation, specifically new health sciences, tasks as an instructor at Stratford University. In the reforming of antiquated teaching methods and systems, developed and implemented techniques for grading of students as well as applying the modern Moodle system for posting of new assignments and different web presentations. Participated within webinars and on-site workshops; consequently, developed significant technical academic aptitudes. Further responsibilities included the set up of a pharmacy laboratory – essential duties including the assembly of apparatus, chemicals, IV infusion, etc. Interdepartmental tasks included working closely with the Dean in the establishment of goals for the University Curriculum. Further assisted in curriculum development for the Nursing program’s class syllabi. Developed strategies to both increase student awareness and nurture an effective learning environment.
Course Instructed (Online and Classroom):
• Medical Terminology, Epidemiology, A&P I and II, Pharmacology I and II, Phlebotomy, and Pharmacy.
Volunteer/Judge Godwin High School Math Science Innovation Center February 2011 – May 2011
AMERICAN INTERNATIONAL BIOTECHNOLOGIES SERVICES, Richmond, VA November - December 2009
Researcher in Application of ELISA Tests (Department of Immunochemistry)
Active member of a team dedicated to the research and practical implementation of ELISA tests. Performed direct, indirect, and sandwich ELISA protocols within the lab environment. Successfully executed Immunology testing, Assay validation protocols. Beyond individual and team-delegated efforts, collaborated directly with the Chief Scientific Officer in charge as well as the Editorial Board.
BOSTWICK LABORATORIES, Glen Allen, VA October – November 2009
Project Coordinator (Clinical Trials)
Essential functions within the project coordination position principally included the collection of clinical research data. Subsequent to data collection, handled data organization. Maintained data compliance with Good Clinical Practice (GCP), Quality Control, Data Query Resolution, record retention and archiving. Organized Clinical Study Design for GastroFISH (chromosomal diagnostic test for colon cancer) in lieu of preparation for FDA presentation. Handled the data obtained in the clinical portion of the Her2/Neu breast cancer test (FISH and IHC), as well as uroFISH.
Project Coordinator (Department of Molecular Biology, Richmond, VA)
Drafted and distributed the Standard Operation Manuals (SOPs). Drafted and applied a variety of designs, manuals, and other materials for the Department of Molecular Biology. Applications included Applied Computer Assay Design, Cervista Software 1.2/Invader Assay, Infiniti HPV-HR QUAD Assay. Utilizing the aforementioned programs, addressed HPV, GC/CT specimens in manual and automatic manners.
PROFESSIONAL EXPERIENCE (CONTINUED)
UNIVERSITY OF BELGRADE,
DEPARTMENT OF CLINICAL BIOCHEMISTRY, Belgrade, Serbia September 2002 – October 2009
Team Leader (Clinical Trials)
Duties within the position of Team Leader were largely divided between clinical trial projects drafting and active laboratory participation. Engaged in study design and built a surrounding theme with specific relation to PhD dissertation. With strict adherence to the Helsinki Declaration, collected and managed informed consent forms, and personal information of patients. Utilized statistical analysis interfaces such as SPSS software and MedCalc. Actively prepared protocols, case report forms, medical reports. With regards to laboratory participation, prepared, with exacting methodology, human blood samples. Measured cardiac biomarkers in blood by using enzyme-linked immunosorbent assay ELISA (R&D Systems, Wiesbaden, Germany) in patients who received clopidogrel, Lovenox SubQ, and Plavix (Drugs responsible to prevent heart attacks and treat different types of myocardial infarction such as non-Q myocardial infarction). Determined the renal function parameters as well as of metabolic status parameters of patients. Worked on developing and managing biopharmaceutical research and development of drugs supervising Clinical Research Associates, Clinical Assistants. Represented Clinical Research results in meetings with clients.
UNIVERSITY OF PERUGIA, Perugia, Italy December 1999
Visiting Assistant Professor
Within a short visiting professor assignment, developed a set of techniques most commonly used to study problems in biochemistry, comparing physiological and chemical approaches in biological research, and medicine.
UNIVERSITY OF SCIENCE, Kragujevac, Serbia October 1997 – December 2001
Assistant Professor
In regards to the instructional responsibilities of the position, prepared an extensive range of lectures, seminars, and laboratory classes. Led class lessons within specialized areas of biochemistry, cell biology, molecular biology, and general physiology. Worked with undergraduate students in areas including research in animal physiology, biochemistry, and methodology of biological science. With regards to research throughout the position, applied concepts in animal cell culture as well as culture of microorganisms, including isolation of cells, maintaining cells in culture, and manipulation of cell culture. Researched physiological and biochemical animal responses based on enzyme activity (enzymes of Antioxidant Defense System) and vitamin concentration in laboratory (in vitro) as well as in changed environmental conditions (in vivo), such as change of oxygen concentration.
EDUCATION AND PROFESSIONAL DEVELOPMENT
UNIVERSITY OF BELGRADE, FACULTY OF PHARMACY,
DEPARTMENT OF CLINICAL BIOCHEMISTRY, Belgrade, Serbia November 2011
Doctor of Pharmaceutical Sciences
UNIVERSITY OF KRAGUJEVAC,
FACULTY OF NATURAL SCIENCE & MATHEMATICS, Kragujevac, Serbia December 2001
Master of Biological Sciences
UNIVERSITY OF KRAGUJEVAC,
FACULTY OF NATURAL SCIENCE & MATHEMATICS, Kragujevac, Serbia September 1996
Bachelor of Science in Biology – Biology
AWARDS
POSTGRADUATE STUDIES
OUTSTANDING STUDENT: RECIPIENT OF THE STATE SCHOLARSHIP
VISITING PROFESSOR: IN 1999, INVITED BY THE RECTOR OF UNIVERSITY IN PERUGIA, ITALY TO BE THEIR VISITING PROFESSOR
DOCTORAL STUDIES
ACADEMIC ACHIEVEMENT IN DOCTORAL STUDIES: IN 2003, RECIPIENT OF THE AWARD OFFERED BY THE MINISTRY OF SCIENCE AND TECHNOLOGY OF REPUBLIC OF SERBIA
OTHER AWARDS
CATEGORY JUDGE AWARD: IN 2011, RECIPIENT OF THE AWARD OFFERED BY THE METRO RICHMOND SCIENCE FAIR
SKILLS
COMPUTER SKILLS
MICROSOFT WORD (WORD PROCESSING/DOCUMENTATION PREPARATION), MICROSOFT EXCEL (BASIC SPREADSHEET APPLICATIONS/FUNCTIONS), MICROSOFT ACCESS (BASIC DATABASE GENERATION/MANIPULATION),
MICROSOFT POWERPOINT (PRESENTATIONS/MANIPULATION)/ DATA GENERATION AND STATISTICAL PROGRAMS/SAS, SPSS AND MEDCALC SOFTWARE TOOLS
LAB SKILLS
GENERAL LABORATORY TECHNIQUES, ORGANIZATION OF LABORATORY ACTIVITIES, MAINTENANCE OF LABORATORY ACTIVITIES, INTERACTION/CLINICAL DIAGNOSTICS/ MANAGEMENT/ PROFESSIONAL COMMUNICATIONS, ADHERENCE TO SAFETY PROTOCOLS, MICROPIPETTES/PIPETTES/ ASEPTIC TECHNIQUES/ SOP WRITE-UP/ LIGHT MICROSCOPE/ PH METER/ TITRATION/DISTILLATION/SPECTROPHOTOMETER/ PCR/ ICP/MS/HPLC/GC/ PATIENT SAMPLE HANDLING TECHNIQUES/ ANTIBODY TESTING METHODS (ELISA)/ LABORATORY CALCULATIONS/ CENTRIFUGATION/FRACTIONATION/MICROBIOLOGY TECHIQUES AND METHODS
PROFESSIONAL SKILLS
SUPERVISING ABILITIES/ STRATEGIC PLANNING/ TECHNICAL WRITING/ INTERPERSONAL COMMUNICATION/ VERBAL COMMUNICATION, CREATIVE THINKING/PROBLEM SOLVING/ ORGANIZATION/ /LEADERSHIP ABILITIES/DETAIL ORIENTED/ABILITY TO COPE WITH A DYNAMIC WORK ENVIRONMENT/PROVEN UNDERSTANDING OF CURRENT GOOD MANUFACTURING PRACTICES (CGMP) REQUIREMENTS/ICH GUIDELINES/USP REQUIREMENTS AND FDA GUIDANCE/HIPAA/USP/NF/ EP/
Note: Full Course-by-Course report for Undergraduate and Graduate Studies was done by Globe Language Services, Inc. (319 Broadway, New York, NY 10007), and is available upon request.
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