Clinical Research Data Entry
Resume:
ONYINYECHI OBIOHA
**** ******* ***** **********, **, 20774
**********@*****.***
CLINICAL RESEARCH SPECIALIST
Highly skilled clinical research associate with a continuous track record of success in clinical environments. Experienced in monitoring multiple site locations, clinical site evaluations, initiation, maintenance, and close-out visits in accordance with Good Clinical Practice (GCP) and company SOPs while maintaining confidential data and following timelines.
PROFESSIONAL SKILL SUMMARY
Knowledge of Company policies and procedures
2 years of experience in clinical research
2 + years of clinical monitoring experience in phases I, II and III clinical trials
Excellent written and oral communication
Excellent technical writing
Excellent knowledge of ICH/GCP
Ability to manage investigative sites
Ability to escalate issues appropriately
Identifies scientific misconduct at the site level
Describes and demonstrates the principals of IP accountability
Ensures timely submission of trip reports according to company timeline
Advanced knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS and Electronic Data Capture platform
CLINICAL RESEARCH TRAINING
GCPs/ICH Guidelines
CAPA
Fraud and Misconducts
NIH Protecting Human Research Subjects
FDA Guidelines (21CFR Parts 50,54,56,312)
HIPAA Regulations
Monitoring Guidelines and Procedures
Regulatory Documents – Review and Processing
SAE And PDs – Review, Reporting and Handling
CRF Review
IATA
THERAPEUTIC EXPERIENCE
• Infectious disease: Hepatitis C
• Oncology: Breast and Lung Cancer
• Endocrinology: Diabetes
• CNS: Bipolar Disorder, Major Depression
• Cardiology: Hypertension, Stroke, Atrial Fibrillation
• Respiratory: Asthma.
PROFESSIONAL EXPERIENCE
Clinical Research Associate, Provance Clinical Inc., CA 07/2016-Present
• Coordinates and provides oversight for specific activities to ensure client and sponsor expectations are met in compliance with any phase study design
• Performs submissions and notifications to Regulatory Authorities, IECs and other bodies according to applicable guidelines, regulatory requirements and SOPs.
• Identifies potential unreported Adverse Events and Serious Adverse Events during patient interview and appropriately processes according to study protocol guidelines and sponsor SOPs.
• Coordinates and conducts PSSV, SIV, and COV visits to assess the qualification of potential study sites, to initiate and instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected, and to terminate studies
• Provides support in maintaining clinical project documents, including Site and/or Data Management Plans, Monitoring Guidelines, Data Review Guidelines, Site Operations Manuals, and Monitoring Visit Letter Templates under guidance of Operational Team Lead
• Acts as primary point of contact for assigned study sites
• Tracks patient enrollment, study supplies, and data entry efforts for assigned study sites.
• Monitors drug inventory, dispensing, compliance and return and ensures that used and expired medication are returned to the sponsor or disposed per pharmacy guidelines.
• Training and re-training of new research personnel, including Study Coordinators, Investigators, and site pharmacists.
• Conducts site equipment’s inspection and site SOP to ensure patient safety and adherence to protocol
Clinical Research Coordinator; Provance Clinical Inc., CA 01/2014-06/2016
• Communicated with sponsors, investigators, clinical monitors and colleagues to ensure effective clinical trial implementation and progress
• Initiated and maintained required clinical and regulatory files
• Coordinated and participated in program activities, grant applications, oral/poster presentation, conferences, departmental meetings, continuing education, investigator meetings, site initiation, interim monitoring and closeout study visits as assigned
• Administered and/or dispensed investigation agents as needed
• Monitored patients' study progress to fulfill protocol and sponsor requirements
• Completed clinical course of study subjects as required per protocol, including, but not limited to, laboratory tests vital sign measurement, EKGs, health status assessment and adverse event monitoring
• Worked closely with Director and Primary Investigator developing/implementing budgets, work schedules and performance requirements for any additional personnel
• Supervised research assistants, residents, medical students, undergrad students in all lab related activities
EDUCATION:
University of Maryland, University College
Master’s in HR Management
2018-Present
CRA ACADEMY
San Bernardino, CA
Accreditation Council for Clinical Research Education (ACCRE)
IVRS : Clinphone
Imo State University, Nigeria
Bachelor of Science Accounting
2002-2006
SKILLS & INTERESTS:
COMPUTER:
Microsoft Office (Excel, SharePoint, Outlook, Visio), Adobe Acrobat.
TRAVEL:
France, South Africa, Indonesia, Spain, Italy, Singapore, Egypt
INTERESTS:
Community Volunteering, Cooking, Reading
HIGHLIGHTS:
Leadership skills
Interpersonal Skills
Communications Skills
Team Player
Problem Solving
Attention to Detail
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