Sponsor Clinical Research
Resume:
Ngozi Uche-Oji
Clinical Research Professional
*********@*****.***
I have always had dreams of helping people improve their health and clinical research is a vital part of advancing healthcare and finding ways to help people live longer robust lives. CLINICAL RESEARCH TRAINING
CLINICAL RESEARCH FASTRACK, 148 hours
• ICH GCP E6 R2
• FDA Regulations 21 CFR Parts 11, 50, 54, 56
• Data Management Systems, Electronic Data Capture
(EDC) systems like MedRio, Medidata, Inform
• Informed Consent Process
• Clinical Trial Operations from feasibility through close- out (Site and Sponsor/CRO responsibilities and duties)
• GDP following ALCOA-C principles
• Identification and reporting of AEs and SAEs
• Quality Assurance, Monitoring and Query Resolution
• Comprehension and Execution of Clinical Trial Protocols
• Maintaining regulatory binder, housing essential documents including but not limited to 1572, Source documents, DOA, Training Logs, ICF, SAE forms,
Financial Disclosures, Subject Enrollment &
Identification Logs, Case Report Forms(CRF), Procedure Manuals, Standard Operating Procedures(SOP), Site
Visit Logs, Correspondences.
CORE QUALIFICATIONS
• Excellent interpersonal and communication skills
• Data management
• Project management
• Project Development Detailed documentation
• Adaptability
• Collaborative learner
• Team Player
• Integrity
• Attention to detail and quality standard.
• Proficient in Microsoft Office applications
EXPERIENCE
AMICIS RESEARCH CENTER-Clinical Research Intern, Los Angeles, USA March 2019-Present
• Data Entry of Clinical Research Information
• Data Reconciliation
• Data Quality Control
• Assist in preparation of Contract-required reports. YORK HEALTHCARE & WELLNESS CENTER, Certified Nursing Assistant, Los Angeles, USA November 2017- December 2019
• Helping patients with activities of daily living (ADLs)
• Serving meals and helping patients eat
• Lifting and moving patients
• Taking vital signs
• Maintaining a clean and sanitized environment
• Facilitating patient care
• Communicating with healthcare team and family members
• Providing companionship and friendship
SAVE OUR FUTURE INITIATIVE (SOFI), Project Manager, Lagos, Nigeria. July 2014 - June 2017
• Initiating, planning and executing projects.
• Managing, monitoring and controlling processes.
• Protocol development
• Preparing adverse event experience reports
• Data Collection
• Development of grants and budgets
• Maintenance of cervical cancer vaccine accountability records (i.e. project we worked on during this period)
• Preparation of reports
• Ensuring protection of individuals who took vaccine and their rights
• Development of consent forms.
GOOD LIVING INITIATIVE, Program Manager, Lagos, Nigeria September 2010 - February 2014
• Daily program management throughout the program life cycle
• Managing risks and issues and taking corrective measurements
• Managing the program's budget
• Recruiting and screening candidates we worked with
• Monitoring case report forms
• Data Collection
• Preparing adverse event experience reports
• Development of grants and budgets
• Protocol development
• Program Administration
CONVOY OF HOPE, Project Manager, Lagos, Nigeria July 2007 - June 2010
• Initiating, planning and executing projects.
• Managing, monitoring and controlling project processes
• Protocol development
• Preparing adverse event experience reports
• Data Collection
• Development of grants and budgets
• Preparation of reports
• Development of call-in forms
EDUCATION
Lagos State University, Lagos, Nigeria - Masters in Public Administration (MPA) June 1998- August 2002
CERTIFICATION
• Medical and Psychiatry and Social Work, Lagos University Teaching Hospital, Lagos, Nigeria.
• Professional Scrum Master (PSM1), Top Group Technologies, Maryland, U.S.A
• Certified Nursing Assistant (CAN), Difai College, Los Angeles, U.S,A.
• Certificate in Clinical Research, Clinical Research Fast Track, Arizona, USA
• Certificate in Foundations of Project Management, Google/Coursera
• Project Initiation: Starting a successful Project, Google certificate
• Good Clinical Practice(GCP): National Institute on Drug Abuse (NIDA) Center for Clinical Trials (CCTN) Clinical Trials Network (CTN) - In Progress
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