Assistant Clinical Research
Resume:
FELIX OKINYI
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Summary:
§ Team player with resourcefulness and tact, communicate effectively when dealing with people of
diverse interests and level of authority, Ability to deal with high pressure environment, quick and
fast learner, adaptable to new work environment, and ability to prioritize tasks.
Professional Experience:
Intern Social/Clinical Research Professional
07 Jan 13 Present
Department of Gastroenterology and Hepatology
UNC Institute for Drug Safety Sciences
Clinical Operations
§ Assist in all clinical aspects of clinical research
§ Knowledge of GCP and ICH Guidelines and ability to follow established regulations,
procedures, and protocols
§ Responsible for inventory, storage, and security of investigational drugs, supplies and
materials for research studies
§ Ensure all clinic and visiting personnel have necessary training and/or requirements necessary
to be in the clinic
§ Study start up and close out
Clinical Study Execution
§ Participate in protocol development, preparation of IRB and CTRC applications and research
project materials with PI and other investigators
§ Plan, coordinate, and monitor several satellite study sites, ensuring enrollment and protocol
compliance and regulatory documents are filed and current.
§ Plan, organize and coordinate project implementation ensuring all compliance is current and
filed appropriately
§ Creating systems of organizing documents and storing them in repositories for efficient
access teamwork and collaborating across organizational lines to achieve institutional goals.
§ Knowledge and experience in using technology to manage records, communicate information,
and compile summaries and status reports.
§ Recruit and enroll subjects, obtain informed consent, develop and monitor appointment
schedules of study subjects
§ Oversee grant proposals, process contracts, and preparation of study budgets
§ Preceptor to research coordinator interns during school semester
§ Interact with research sponsors and/or CRO's, and IRB's
§ Gather, edit, analyze, and report data from research projects
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Technician I Intern Gentris Corporation
16 Aug 12 21 Dec 12
§ Assesses daily accessioning activities and work prioritization as well as communication with study
directors.
§ Accessions client samples using approved standard operating procedures.
§ Assists in sample receipt and verification of client samples.
§ Accessions client samples into appropriate databases.
§ Logs and maintains samples in LIMS freezer database.
§ Reviews accession paperwork.
§ Maintains client study files.
§ Assists in writing and editing SOP's.
Nursing assistant VA Medical Center, Durham NC
2009 Present
Maxim staffing solution and Advantage on call
§ Assisting technicians in medical/surgical procedures by providing necessary equipment.
§ Assisting in transfers and repositioning.
§ Obtaining vital signs documenting on the computer.
§ Maintaining safety and infection control by cleaning rooms and changing patient linens.
§ Providing health care checks for diverse patients with spinal cord injury, CVA and Congenital
disabilities.
§ Maintaining skin integrity by toileting, repositioning, showers and grooming.
Summary of Qualification in training CTRA (Durham Tech)
Preparing, and training on protocol to a study team at various new sites.
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Performing a mock initiation and evaluation of a new site.
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Evaluating essential documents for a new site.
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Reviewing the CFR, ICF, source documents and 1572 for accuracy.
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Preparing reports monitoring assessment of the CFR, patient diaries, ICF, form 1572 and the packet
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inserts.
Defining ICF requirements to the subject.
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Education
Durham Technical Community College, Durham, NC April 2010 Present
§ AS Clinical Trials Research Associate, Clinical research (CTRA)
Thomas Health care, Raleigh NC Jan 2009 Feb 2010
§ Certified nursing assistant (CNA)
University of Eastern Africa, Kenya Jan 2002 Dec 2006
§ BSc. General Biology
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Minor Chemistry
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Certifications & Licenses
NIH Web based training course "Protecting Human Research Participants".
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Shipping Materials with Dry Ice
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Transporting Dangerous Goods (Mayo Medical laboratories)
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Shipping of Category A, Infectious Substance Affecting Humans Category B, Biological Substance
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Licensed Nurse Assistant
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CPR certified
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Contact this candidate