Highly organized, flexible, and motivated budding Clinical Research Professional with exceptional attention to detail and a dedication to developing a precise work ethic in the clinical research field; Bachelor's degree in Chemical Engineering with an aptitude for analytical thinking and useful experience in field sampling, laboratory research methods as well chemical substances analysis; Expertise in Equipment Qualification & Validation (IQ/OQ/PQ), laboratory equipments' software and analytical methods ensuring compliance with Good Manufacturing Practice (GMP) regulations; Experienced in adhering to safety guidelines and SOPs in compliance with ICH/GCP, ISO and OSHA guidelines; Top-notch leadership and project management skills with functional experience of managing, supporting and improving the efficiency of multiple projects, including developing and implementing web and database technologies to improve processes and save money;
CLINICAL RESEARCH PROFESSIONAL
Serious Adverse Events
Health Insurance Portability and Accountability (HIPPA) Privacy Rule
Case Report Forms and EDC
SAP/ERP/Project Implementation *Annual ICH/GCP Training
Patient Health Information(PHI) Act
Investigational New Drug (IND) Application
Database Management (DMS/SME)
FDA Regulations and Requirements
Quality Control & Assurance *Essential Documents
Study Drug Accountability
Platforms: Windows (all desktop and server version), Mac OS, UNIX (Telnet)
Databases: Oracle 9i, MS SQL Server 2000 and 2005, MYSQL, T-SQL, MS Access
Microsoft Office Suite 2003/2007/2010/2013 *DocX Tools
Microsoft Office 365 (Professional) *OmniPage Pro 14
Microsoft Publisher *Research Pro
Protocol Number A4091058: A Multi-Center, Phase 3 Randomized, Double-Blind, Active-Controlled, Study of the Long-Term Safety And Efficacy Of Subcutaneous Administration Of Tanezumab In Subjects With Osteoarthritis Of The Hip Or Knee.
Protocol Number D600C00002: Phase 1b/2a, Randomized, Partial Double-Blind, Single-dose, Active-Controlled, Dose Ranging Study to Evaluate the Safety of MEDI8852 in Adults with Acute, Uncomplicated Influenza.
Protocol Number 201038: A Multi-Center, Prospective, Post-authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients Using Inhaled UMEC/VI Combination or Inhaled UMEC versus Tiotropium.
Masters Business Administration (MBA)Keller Graduate School of Management － City, State
Masters Project Management (MPM) - Anticipated
Ogun State University, Ago-Iwoye, Ogun State NIGERIA
Graduate Certificate, Project Management
Texas A&M University, Corpus Christi, TX - Certificate, Chemical Plant Operations & Process ControlKeller Graduate School of Management － City, State
DiplomaHolt Computer College － City, State, USA
Certificate, Fundamentals of Clinical Research & Site Monitoring StrategiesSolar Biomedical Consulting Services － City, State
Dissertation: "Branding in Cultural Industries" examines the different approaches to marketing and product branding in industries globally. Questions how cultural industries vary in mindscape, materiality and branding.
Project Coordinator/Data ManagerCompany Name － City, State
An integrated power generation and alternative-energy solutions company distributing renewable fuel and energy products and solutions worldwide Operations Design/Production Planning/Project and Data Management Defined and created project scope for CNG/LPG mother station valued up to $50M Total Installed Cost, created and updated project plans, identified resources, monitored project progress and addressed issues, coordinated and facilitated project team meetings; Successfully monitored, evaluated and validated laboratory facilities and equipments, reviewed field performances, recorded operating data, such as process conditions, test results, or instrument readings and QC data; Analyzed and created production plans, monitored inventory levels, coordinated materials usage, delivery schedules and other related duties to meet production demands; Conducted project reviews to identify best practices and opportunities for improvement; Actively wrote scientific and technical procedures/manual, created quick start guides and end-user installation manuals for proprietary software applications; Supervised and coordinated off-site testing as necessary, resolved design and construction issues with engineers and contractors; identified poor performance areas and proposed solutions in the form of models and charts.
Workflow Coordinator/Operations AnalystCompany Name － City, State
An international law firm with offices around the world with over 500 attorneys specializing in IP, Trademark and Copyright Litigation) Effectively managed and monitored multiple business/technology project requirements, schedules and deliverables to report progress to Center Manager and other senior executives; Proofread and edited over 100K print & electronic materials to ensure deliverables are consistent and error-free; Coordinated multiple data management projects on multimillion dollar deals: defined project expectations, analyzed and developed solutions, documented results and advised decision makers on the appropriate courses of action; Proactively managed client expectations and wrote memos and reports to document recommendations and results; Developed critical client data management systems utilizing SharePoint 2007 and 2003 to improve several functionalities saving company over $1.5M; Developed and implemented database applications for several practice groups within the firm and trained outside vendors in ERP systems reducing department's overhead by over $500,000; Played major role in ensuring integrity of a multi-million dollar data mining/coding project, successfully serving as point person for executives, managers, clients, and vendors to ensure proper lines of communication; Created and maintained a data entry and data consolidation tool using Excel VBA to actively incorporate the use of several advanced and complex Excel formulas and macros with MARS data entry module to integrate metrics data downloads between multiple worksheets and increase efficiency of data management; Led the coordination and presented product documentation and demonstrations to train other team members in the coordination and usage of several processing applications involving third party vendors as well as provided consultation to vendors on system implementation.
Company Name － City, State
Completed 72 hours of hands-on training on monitoring expectations for CRAs according to the Code of Federal Regulations (CFRs) and the ICH/Good Clinical Practice Guidelines (GCPs);.
Learned about assessing and ensuring overall integrity of study implementation, as well as investigational sites' adherence to study protocol requirements in accordance to GCP;.
Participated in multiple simulations of actual trial monitoring situations, performing all clinical monitoring/site management activities such as investigator selection, IRB approval, CRF review, informed consent process and procedure, source document verification, regulatory compliance and drug accountability and adverse event assessment, how to track essential documents and other data throughout the duration of each study, in accordance with ICH/GCP, FDA guidelines, local regulations and sponsors' Standard Operating Procedures;.
Acrobat Reader, charts, Clinical Research, consultation, client, clients, data entry, Data Management, data mining, database applications, Databases, Database Management, delivery, design and construction, documentation, ERP, Excel VBA, Forms, GCP, Good Clinical Practice, IND, Insurance, inventory levels, IP, law, Legal, regulatory compliance, Litigation, Mac OS, macros, MARS, materials, meetings, MS Access, Excel, Microsoft Office, Microsoft Office Suite, Microsoft Project, Microsoft Publisher, SharePoint, Windows, 2000, MYSQL, OmniPage Pro, Oracle 9, power generation, Process Control, coding, progress, Project Management, project plans, Quality Control, quick, Research, SAP, scientific, MS SQL Server, Telnet, T-SQL, UNIX, Utilities, WinZip, Writer
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Keller Graduate School of Management
Holt Computer College
Solar Biomedical Consulting Services
Job Titles Held:
Project Coordinator/Data Manager
Workflow Coordinator/Operations Analyst
Masters Business Administration (MBA) Masters Project Management (MPM) - Anticipated
Ogun State University, Ago-Iwoye, Ogun State NIGERIA B.Sc : Honors, Industrial Chemistry (Chemical & Manufacturing Engineering) Graduate Certificate, Project Management
Texas A&M University, Corpus Christi, TX - Certificate, Chemical Plant Operations & Process Control Diploma Certificate, Fundamentals of Clinical Research & Site Monitoring Strategies
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