Management Project
Resume:
EDWARD BRUNO
Apt. ****
Santa Clara, CA, 95054
**********@*****.***
Clinical Trial Monitoring, Contract, Grant and Project Management, Research Scientist, Clinical Laboratory Management
Healthcare researcher seeking a position with an organization that can utilize specialized knowledge base regarding research methodologies, clinical trial monitoring and management, clinical hospital-based medicine and research laboratory management including clinical research scientist, regulatory operations, human resource operations, recruitment and budget operations, clinical research project management as well as an in-depth understanding of statistical analysis tools used to measure both qualitative and quantitative data sets.
• Monitoring and Management of Clinical Trials
• Grant Writing and Contract Administration Management
• Clinical Research Laboratory Administration
• Bone Marrow Transplant Facilities Management
• Hospitals: Clinical Laboratory Management / Facilities Management (Department of Medicine)
• Infectious Diseases
• Clinical Research Project and Data Management
• Public Policy
• Technology Savvy
• Regulatory Management
• Human Resource Management
• Pharmaceuticals: Research Scientist
• Policy Evaluation
• Financial Management
• Operational Analysis
• PhD Level Clinical Research Scientist
QUALIFICATIONS PROFILE
Strong background in prioritizing, monitoring tracking and managing all phases of clinical trials.
Strong analytical background with the ability to work independently on multiple clinical medicine, research and business projects.
Effectively lead and manage top-performing project management teams, successfully interacted with legal personnel, nurses, CRA’s and clinicians.
Established legal,, clinical trial and scientific agreements with biotechnology and government agencies.
Excel in defining and implementing policies, procedures and operational systems that boost productivity, efficiency and quality of operations, including regulatory, financial and human resource.
Utilize extensive knowledge of scientific equipment to measure and quantify viability of research.
Consistently focus on ensuring development of high-standard research methodologies.
Proven ability to adapt strong PhD level research skills to diverse organization needs.
Successfully managed both clinical medicine (hospital) and clinical research laboratories.
FUNCTIONAL COMPETENCIES
Successfully written grants that result in awards vital to funding critical research.
Supervise and monitor clinical trials, clinical medicine, clinical research and business projects of multiple personnel. Expert in regulatory affairs and quality assurance for clinical trials and clinical projects.
Successfully coordinate efforts of research and development department with other factions for the purposes of development opportunities and knowledge sharing.
Successfully managed and lead groups of clinical trial research associates, fellow researchers and hospital laboratory personnel while enabling team collaboration and growth. I have helped design, plan and implement the overall direction of clinical research projects. I have intimately involved in the development of relevant documents for Phase 1 through 3 studies while supporting cross-functional study teams within clinical operations. I have successfully achieved achieve study objectives and milestones within timelines and budgets. I also identified and tracked timelines, milestones, critical study activities, and budgets.
Bring to the organization an in-depth understanding related to developing and validating analytical test methods for clinical trials and clinical research projects.
Demonstrate highly effective leadership skills in successfully coordinating and supervising the efficient research of clinical fellows, graduate and undergraduate students.
Utilize specialized knowledge base to conduct market research and develop salient programs for the benefit of relevant population.
Form strategic and collaborative relationships with various resources in order to gain access to and share knowledge.
Directly participate and lead various planning meetings as well as panel discussions in order to stay abreast of relevant research and field information.
Utilize technology proficiency in Microsoft Office Suite, Outlook, Cambridge Structural Data Base, ACD Labs ChemSketch, SMART, SAINT, SHELXTL Suite, Mercury, CERIUS2, Sigma Plot, CrystalClear, CrystalStructure, Twin Solve, Inorganic Crystal Structure Database, ChemDraw, Adobe Acrobat.
ACADEMIC CREDENTIALS
M.S. – Southern Connecticut State College
B.S. – University of Connecticut
Registered Medical Technologist – American Society of Clinical Pathologist
PROFESSIONAL CAREER TRACK
HEMATOLOGY RESEARCH, Abbott Laboratories 04/2011-07/2012
Research and Development of new staining procedures for peripheral blood smears
Development of next generation of Abbott hematology analyzers
Work with Marketing and Sales on developing next generation analyzers
GRANT ADMINISTRATION, University of Illinois (Department of Pharmacology) 01/2007-07/2010
Managed all Human IRB and Animal Care Committee (ACC) protocols.
Managed extensive animal research component including the directing of animal-based research by all principal investigators and their co-investigators.
Responsible for writing, submission, management and coordination of several arge Program Projects.
Responsible for several individual R01’s and other grants and NIH-sponsored projects.
Maintained oversight of all budgetary, personnel and research. Primary responsibilities included supervision, management and coordination of multiple components of large grants and program projects.
Coordinated and led multidisciplinary interactions within the projects.
Developed and coordinated all committees included within each grant or project.
Managed and coordinated Illinois state grant on embryonic stem cells.
Responsible for the legal management and coordination of annual Progress Reports for all Program Projects and R01’s to the NIH and NHLBI.
Responsible for review of selected Program Projects and individual R01’s for the Department of Pharmacology.
Collaborated regularly with the NHLBI/NIH for compliance with new regulations and for submission of new grants and program projects as needed.
ADMINISTRATIVE DIRECTOR OF MYELOPROLIFERATIVE RESEARCH CONSORTIUM, University of IL. 01/2004-01/2007
Primary responsibilities included complete management, coordination and operational oversight of an extensive $19.6M multi-institutional research consortium, an alliance of international scientists and clinicians studying the myeloproliferative diseases.
Responsible for development of consortium infrastructure after funding. Successfully worked with all legal, scientific and clinical trial personnel to establish legal and scientific language for clinical trial agreements, statements of work and clinical science agreements.
Managed all budgets, scientific and monitoring of clinical trials and cores as well as coordinated numerous interactions between research groups of program project. Successfully managed and lead groups of clinical trial research associates, fellow researchers and hospital laboratory personnel while enabling team collaboration and growth.
Designed, planned and implemented the overall direction of clinical research projects. Developed relevant documents for Phase 1 through 3 studies while supporting cross-functional study teams within clinical operations. Successfully achieved achieve study objectives and milestones within timelines and budgets. Identified and tracked timelines, milestones, critical study activities, and budgets.
Successfully assisted in writing, submitting and total management of several R01 grants obtained by the PI, including Department of Defense Grant.
Organized and staffed board and committee meetings of various grants as needed.
Initiated and developed the monitoring computer-based monitoring system for all clinical trials. Set up the computer-based system for clinical sites to complete all forms for clinical trials associated with the international consortium.
LABORATORY MANAGER AND SENIOR RESEARCH ASSOCIATE, University of Illinois 01/2002-01/2007
Initiated, managed and monitored several clinical trials performed within the Hematology/Oncology Section of the Department of Medicine, including interleukin 3, interleukin 6, pixy and a low intensity bone marrow transplantation of patients with Idiopathic Myelofibrosis..
Initiated and managed all aspects of in vitro cell-based collaborations with Abbott Laboratories (Abbott, IL.), Millennium Pharmaceuticals (Boston, MA) and Amgen, Inc. (Thousand Oaks, CA).
Responsibilities included initiation and management of all human and animal IRB-related protocols and planning and management of laboratory research, grants and contracts.
Directly involved with Bone Marrow Transplant Center in assisting staff to ensure quality patient care and state and federal compliance (FDA,FACT, JCAHO and CLIA).
Managed clinical research laboratories while performing clinical testing on patient samples in hospital setting. Active in Clinical Patient Care testing with Department of Pathology. Familiar with clinical medical laboratory operation in Department of Pathology.
Managed all research budgets including personnel as well as procurement process for supplies and equipment.
Managed maintenance protocols of research laboratories.
Mentored post-doctoral fellows, medical students and clinical fellows in laboratory research and patient testing.
Played an important role in recruitment of new laboratory personnel.
Successfully helped write, submit and managed all R01 Grants
Worked with Head of the Department of Medicine planning construction of new research buildings, reading of construction diagrams.
Research and Development Scientist, BioWhittaker,Inc. 01/1998-12/2002
• Responsible for the planning, initiation and completion of novel media development projects in the Research and Development Department. Work independently of Director of Research and Development. Responsible for development of new products resulting from research projects.
• Collaborated with Marketing Department to promote the sale of novel products, including customer relations and clinical trials.
• Initiate the planning of the experimental design required to discover novel products for clinical trials.
• Supervise performance of predesigned experiments by research staff.
• Utilize project scheduler to develop accurate time lines for completion of project and development of novel products.
• Work with QA/QC Department and Manufacturing Department to formulate SOPs and other documentation necessary for the introduction of new products.
• Work with Technical Support Staff and Sales Force to establish promotion of new products.
• Managed a project utilizing bioreactors to develop animal protein-free medias utilized in the in vitro production of influenza vaccine.
• Managed a project to develop novel medias designed to expand the in vitro and in vivo growth of human hematopoietic stem and progenitor cells.
• Managed a project to utilize the “plasticity” of human hematopoietic stem cells to differentiate primitive hematopoietic cells into both dendritic cells and osteoclasts in vivo and in vitro. These progenitor cell populations will then be utilized to develop novel high-throughput cell-based assays for clinical trials studying such bone disease states as osteoporosis as well as drug development. Research and Development Scientist, SyStemix,Inc. 01/1994-01/1998
• Responsible for the planning, initiation and completion of in vitro and in vivo projects in the Cell Biology Section of Research and Development.
• Worked independently of Director of Research and Development.
• Involved in a clinical trial by successfully modifying the hematopoietic tissue acquisition program to improve yield of human hematopoietic progenitor and stem cells necessary for transplant and in vivo gene therapy protocols. Helped clinical sites monitor transplant clinical trials.
• Reformulated media utilized to collect hematopoietic tissues (bone marrow, etc.).
• Wrote company SOPs to establish several new hematopoietic assay systems to help qualify preclinical data for clinical trial.
EARLIER EXPERIENCE
- MANAGEMENT OF CLINICAL TRIALS, HOSPITAL LABORATORIES AND CLINICAL RESEARCH LABORATORIES
- RESEARCH SCIENTIST: PhD Level: University of Illinois
- LABORATORY MANAGER OF CLINICAL UNIVERSITY SECTION OF HEMATOLOGY/ONCOLOGY, University of Illinois School of Medicine and University of Indians School of Medicine
- PROJECT AND GRANT MANAGEMENT IN SCIENTIFIC AND BIOTECHNOLOGY FIELD
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