Henry Ikhile
Henry Ikhile
Gardena, CA 90247 | ------------ | ------------ | ------------/in/henry-ikhile-b44b7469
ASPIRING CLINICAL RESEARCHER
Professional in Clinical Research with over 10 years of experience in the management of quality control to strict standards. A Phlebotomist Technician, detail-oriented, personable, lifelong learner intensively trained in ICH-GCP E6(R2) for clinical research. Highly adaptable with a proven ability to collect clean, credible data according to ALCOA-C principles, work with diverse populations and perform under pressure.
SKILLS & CORE ATTRIBUTES
Good Clinical Practice (GCP)
Clinical Trials
Meticulous attention to detail
Safety & Quality Assurance
Venipuncture & Capillary Puncture
Blood Specimen Storage Data Management (eDC/eCRF)
Personable and Highly organized
Goal-oriented
Blood Collection & Handling Safety
Patient & Donor Care Excellent Communicator
Ethics and Participant Safety consideration
Quality Control & Assurance
Medical Records Review
Computer Skills: Microsoft Office Suite, eDC/eCRF, Oracle Primavera Project Planning P3 & P6, Microsoft Project
EXPERIENCE SUMMARY
CLINICAL RESEARCH FASTRACK, Scottsdale, AR, 2020 – January-March
Clinical Research Trainee
? Receive mentoring by industry professionals in GDP and 21CFR Parts 11,50,54,56 and common rule 45CRF46
? Learn and practice informed consent process & Data Management; identified and reported AE’s and SAE’s
? Assists staff in collecting data to meet protocol requirements in a timely manner.
? Identify, track, and resolves basic EDC queries.
? Practiced and executed clinical trial operations from feasibility to close out
? Good Documentation Practices (GDP) following ALCOA-C principles
? Comprehend & execute Clinical Trial Protocols; monitor Quality Assurance & Query Resolutions
? Organized essential documents in regulations binder (1572, DOA, Training Logs, source documents)
Multispecialty Aesthetic Clinical Research Organization (MACRO), LLC March-August
Clinical Research Assistant- Internship
? Assists the Clinical Research Coordinators in protocol assessments, planning activities and coordinating multiple research studies
? Assists in the preparation of CRF/eCRF data and source document collection through the regulatory approval process.
? Daily Data Management (eDC/eCRF)
? Evaluate AE/SAE, Concomitant with patients
? Identify, track, and resolves basic EDC queries.
? Assists staff in collecting data to meet protocol requirements in a timely manner.
? Assists the Clinical Research Coordinators in preparing and submitting documents to institutional review board
? Responsible for completing feasibility questionnaire to Patients
? Participates in subject / patient recruitment and evaluation of eligibility
? Assist in recruiting/screening potential patients and verifying for protocol eligibility including presenting non-medical trial concept and details to patients, and participate/facilitates in the informed consent process
? Reviews inclusion / exclusion criteria with Principal investigator / Sub-PI / RN to assure subject eligibility
? Obtains informed consent from research subjects prior to any study-related procedures and documents appropriately
? Maintains patient screening enrollment logs
? Reviews protocol requirements, informed consent form and follow-up procedures with potential study subjects
? Vital signs monitoring, Inventory and supply management
UNITED STATES GYPSUM CO (USG), Torrance, CA, 2019
Quality Compliance Production Team Lead
? Performed daily quality checks and recorded results
? Planned, assisted to develop and executed the overall Compliance and Quality Assurance strategy
? Recommended, developed and reviewed QA standards, policies and procedures for all functions of quality and testing in accordance with company standards
ADDAX PETROLEUM DEVELOPMENT NIGERIA LIMITED, 2009 – 2018
Quality Assurance / Quality Control Supervisor
? Carried out field quality control inspections; generated As-built documentation
? Conducted Procedure and Welders Qualification Tests
? Monitored contractor’s daily production; performed internal audit functions
? Maintained consistent GMP & GDP in compliance with obligations
? Performed quality assurance, monitoring and query resolution
? Wrote, reviewed and approved SOP, other procedures, and followed up with implementation
EDUCATION
BEng (Hons) in Electrical / Electronic Engineering, Ambrose Alli University (Nigeria), 2006
PROFESSIONAL DEVELOPMENT & AFFILIATIONS
Network+, ABCO Institute of Technology, Inglewood, CA, 2019 – 2020
Security+, ABCO Institute of Technology, Inglewood, CA, 2019 – 2020
Member, Nigerian Institute of Safety Professionals (NISP), Nigeria
Licensed Adjuster-All lines, Texas Department of Insurance, TX
CERTIFICATIONS
Clinical Research Professional, Clinical Research Fastrack, Arizona, 2020
Good Clinical Practice (GCP) 319589, Syneos Health-2020
IATA (Transportation of dangerous goods), Mayo Clinic-2020
Certified Phlebotomy Technician (CPT1) Certificate number R2P7T9L3- 2020
Henry Ikhile
Gardena, CA 90247 | ------------ | ------------ | ------------/in/henry-ikhile-b44b7469
ASPIRING CLINICAL RESEARCHER
Professional in Clinical Research with over 10 years of experience in the management of quality control to strict standards. A Phlebotomist Technician, detail-oriented, personable, lifelong learner intensively trained in ICH-GCP E6(R2) for clinical research. Highly adaptable with a proven ability to collect clean, credible data according to ALCOA-C principles, work with diverse populations and perform under pressure.
SKILLS & CORE ATTRIBUTES
Good Clinical Practice (GCP)
Clinical Trials
Meticulous attention to detail
Safety & Quality Assurance
Venipuncture & Capillary Puncture
Blood Specimen Storage Data Management (eDC/eCRF)
Personable and Highly organized
Goal-oriented
Blood Collection & Handling Safety
Patient & Donor Care Excellent Communicator
Ethics and Participant Safety consideration
Quality Control & Assurance
Medical Records Review
Computer Skills: Microsoft Office Suite, eDC/eCRF, Oracle Primavera Project Planning P3 & P6, Microsoft Project
EXPERIENCE SUMMARY
CLINICAL RESEARCH FASTRACK, Scottsdale, AR, 2020 – January-March
Clinical Research Trainee
? Receive mentoring by industry professionals in GDP and 21CFR Parts 11,50,54,56 and common rule 45CRF46
? Learn and practice informed consent process & Data Management; identified and reported AE’s and SAE’s
? Assists staff in collecting data to meet protocol requirements in a timely manner.
? Identify, track, and resolves basic EDC queries.
? Practiced and executed clinical trial operations from feasibility to close out
? Good Documentation Practices (GDP) following ALCOA-C principles
? Comprehend & execute Clinical Trial Protocols; monitor Quality Assurance & Query Resolutions
? Organized essential documents in regulations binder (1572, DOA, Training Logs, source documents)
Multispecialty Aesthetic Clinical Research Organization (MACRO), LLC March-August
Clinical Research Assistant- Internship
? Assists the Clinical Research Coordinators in protocol assessments, planning activities and coordinating multiple research studies
? Assists in the preparation of CRF/eCRF data and source document collection through the regulatory approval process.
? Daily Data Management (eDC/eCRF)
? Evaluate AE/SAE, Concomitant with patients
? Identify, track, and resolves basic EDC queries.
? Assists staff in collecting data to meet protocol requirements in a timely manner.
? Assists the Clinical Research Coordinators in preparing and submitting documents to institutional review board
? Responsible for completing feasibility questionnaire to Patients
? Participates in subject / patient recruitment and evaluation of eligibility
? Assist in recruiting/screening potential patients and verifying for protocol eligibility including presenting non-medical trial concept and details to patients, and participate/facilitates in the informed consent process
? Reviews inclusion / exclusion criteria with Principal investigator / Sub-PI / RN to assure subject eligibility
? Obtains informed consent from research subjects prior to any study-related procedures and documents appropriately
? Maintains patient screening enrollment logs
? Reviews protocol requirements, informed consent form and follow-up procedures with potential study subjects
? Vital signs monitoring, Inventory and supply management
UNITED STATES GYPSUM CO (USG), Torrance, CA, 2019
Quality Compliance Production Team Lead
? Performed daily quality checks and recorded results
? Planned, assisted to develop and executed the overall Compliance and Quality Assurance strategy
? Recommended, developed and reviewed QA standards, policies and procedures for all functions of quality and testing in accordance with company standards
ADDAX PETROLEUM DEVELOPMENT NIGERIA LIMITED, 2009 – 2018
Quality Assurance / Quality Control Supervisor
? Carried out field quality control inspections; generated As-built documentation
? Conducted Procedure and Welders Qualification Tests
? Monitored contractor’s daily production; performed internal audit functions
? Maintained consistent GMP & GDP in compliance with obligations
? Performed quality assurance, monitoring and query resolution
? Wrote, reviewed and approved SOP, other procedures, and followed up with implementation
EDUCATION
BEng (Hons) in Electrical / Electronic Engineering, Ambrose Alli University (Nigeria), 2006
PROFESSIONAL DEVELOPMENT & AFFILIATIONS
Network+, ABCO Institute of Technology, Inglewood, CA, 2019 – 2020
Security+, ABCO Institute of Technology, Inglewood, CA, 2019 – 2020
Member, Nigerian Institute of Safety Professionals (NISP), Nigeria
Licensed Adjuster-All lines, Texas Department of Insurance, TX
CERTIFICATIONS
Clinical Research Professional, Clinical Research Fastrack, Arizona, 2020
Good Clinical Practice (GCP) 319589, Syneos Health-2020
IATA (Transportation of dangerous goods), Mayo Clinic-2020
Certified Phlebotomy Technician (CPT1) Certificate number R2P7T9L3- 2020