Clinical Research Manager
Resume:
Irving Ortiz
*********@*****.*** 787-***-**** https://www.linkedin.com/in/irving-ortiz-457250b5/
Clinical Project Manager
Clinical Research Strategic Planning Project Management
Dedicated clinical research professional with experience in science, healthcare management, and investigation. Adept at developing systems to track projects including ethical information, patient recruitment activities, and financial management. Skilled in collaborating with all members of the organization to achieve business and financial objectives. Bilingual in Spanish and English with technical proficiency in data acquisition/management software (REDCap), Microsoft Office, iOS and Statistical / Analytical Software. Participated in muscle basic science research in the Jerry Lewis Muscular Dystrophy Association Center and ALS Center in Houston, TX. Co-authored 13 peer-reviewed publications, two book chapters, 23 abstracts, and participated in multiple seminars and symposiums.
Clinical Research
Clinical Trial Management
Project Management
Grant Writing
Laboratory Management
Analysis & Statistics
Interviewing Techniques
Basic Science Research
Patient Recruitment
Therapeutics
Development & Retention
Regulatory Compliance
Budgeting & Forecasting
REDCap Training
PROFESSIONAL EXPERIENCE
PUERTO RICO SE LEVANTA - San Juan, Puerto Rico
VOLUNTEER 2017 – 2018
Worked as a volunteer with a primary care group assisting people affected by the hurricanes Irma and Maria that passed thru Puerto Rico on September 2017.
Collaborated under the direction of Carlos Mellado López, MD, President of Canóvanas Medical Center, CSP and ex-Patient Ombudsman of the Office of the Patient Advocate of Puerto Rico.
FDI CLINICAL RESEARCH (CRO), San Juan, Puerto Rico 2014 – 2016
Clinical Project Manager / Consultant
Recruited by the Chief Medical Officer of the CRO to work in Infectious Diseases Projects (Chikungunya, Zika) and Liver Disease (NASH).
Managed a collaborative clinical study between a School of Public Health and FDI Clinical Research (CRO).
Oversight of clinical sites, including site start-up and subject recruitment.
Recruited and supervised 35 temporary research assistants.
Involved in meeting schedules and resolving problems and conflicts.
Interfaced with research assistants to coordinate their activities as agreed upon in the study plan.
Scheduled tasks and ensured research assistants fulfilled their responsibilities.
Managed research projects including estimating resources, progress, and completion timeframe.
Directed and coached research assistants in informed consent forms, interviewing techniques, and data acquisition/management software (REDCap).
Conducted visits at clinical sites to communicate with hospital administration, research assistants and clinical personnel to support the research project.
Responsible for delivering the project on time and on budget.
Participated in weekly update call with collaborator and data management/statistics group.
Interacted frequently with the CRO senior management.
UTICORP – UTILIZATION MANAGEMENT CORPORATION, San Juan, Puerto Rico 2008 – 2014
Project Manager
Recruited Medical Doctors for peer review panel.
Worked with management to prioritize business and information needs.
Located and defined new processes improvement opportunities.
Interpreted data, analyzing results using statistical techniques.
UNIVERSITY OF TEXAS – MEDICAL BRANCH, Galveston, Texas 2004 – 2008
Assistant Professor – Department of Neuroscience and Cell Biology
Collaborated in building a research infrastructure of a new building and also organized the research activities of research groups.
Managed 7 independent research groups consisting of 27 international scientists within a 7,500-square foot wet laboratory.
Oversaw 3,000 square foot laboratory while leading a diverse, international team of four faculty members, two post-doctoral fellows, four graduate students, and one technician.
Participated in the design of two Scientific Research Laboratory floors with 15,000 square feet of wet laboratory space plus common areas and office space.
1.Saved money and floor space.
2.Promoted interaction, communication and collaboration between research groups.
3.Increased efficiency.
Member of the Cryo EM Center Steering Committee.
Member of the Department of Biochemistry and Molecular Biology faculty admission committee.
Experience in Biochemistry, Cell Biology, Protein Purification, Cell and Tissue Culture.
Interacted with Facilities Operation and Management in the design and construction of a BSL3 Cryo Electron Microscopy Center. The first facility of this kind in the world. (Cryo-Electron Microscopy Center for Macromolecular Systems Imaging).
Completely bilingual, (English/Spanish) and bicultural.
BAYLOR COLLEGE OF MEDICINE, Houston, Texas 1996 – 2004
Assistant Professor – Department of Neurology
Trained and coached faculty members, graduate students, post-doctoral fellows, and technicians in laboratory equipment, procedures, and techniques.
Participated in Federal and Private Grant applications.
Independent design of scientific experiments and successful projects completion.
Computer-proficient in Windows environment, Word, Excel, PowerPoint, Access, Adobe Photoshop, Analytical & Statistical Software, iOS, some experience in LINUX and UNIX environments, etc.
BASIC SCIENCE RESEARCH ACHIEVEMENTS
Co-author in 13 peer review publications, 2 book chapters, 23 abstracts plus multiple seminars and symposium participations. During my tenure at the laboratory we produced 58 peer review publications, 3 books, 26 book chapters and 130 abstracts.
The laboratory was continuously supported for 29 years by Federal and Private Agencies grants.
Discovered 3 new proteins in invertebrate skeletal muscle (α, β, γ filagenins).
Discovered a new structure in the myosin containing thick filament in invertebrate skeletal muscle.
Collaborated in the design and construction of the first BSL3 Cryo Electron Microscopy Center in the world to interact with the BSL4 National Laboratory in Galveston, Texas
Participated in the design and construction of a self-contained environmental habitat sent into space in the NASA Space Shuttle Columbia.
EDUCATION & CREDENTIALS
Bachelor of Science in Biology & Chemistry
University of Houston, Houston, Texas
Certificate in Medical and Healthcare Management
Jesse H. Jones Graduate School of Management, Rice University, Houston, Texas
Biomedical Research Investigator – Collaborative Institutional Training Initiative (CITI Program)
Harvard School of Public Health
Good Clinical Practice – Collaborative Institutional Training Initiative (CITI Program)
Harvard School of Public Health
Introduction to the Principles and Practice of Clinical Research Certificate
National Institute of Health Clinical Center
Conflict of Interest – Collaborative Institutional Training Initiative (CITI Program)
Harvard School of Public Health
Protecting Human Research Participants Certificate
National Institute of Health Office of Extramural Research
EMBO Course on Image Processing for Cryo EM
Institute of Structural and Molecular Biology, School of Crystallography, University of London, Birkbeck, London, United Kingdom
UTICORP – Utilization Management Corporation, San Juan, Puerto Rico.
HIPAA & HITECH
Fraud Waste & Abuse (FW&A)
Conflict of Interest
Sexual Harassment Policy, Discrimination and Hostile Environment
Policy on Domestic Violence in the Workplace
Policy on Use and Abuse of Controlled Substances
Policy on Use of Alcohol Sexual Harassment
Confidentiality
UTMB Faculty Training Program– University of Texas Medical Branch, Galveston, Texas.
Conflict of Interest
Standards of Conduct
Information Protection
ADA Training for Supervisors
Universal Precautions
Financial Requirements of Sponsored Projects for Principal Investigators
Level of Effort Discussion for Principal Investigators
HCA Trainer (Hazard Communication Act)
Laboratory Biological & Chemical Safety Trainer
Basic Radiation Safety
Laboratory Training
Institutional Animal Care and Use
General Fire Safety Training
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