Medical Data

CHUKWUDI.C. EZII

Rockville, MD ***** 240-***-**** ************@***.***

Professional Summary

Professional and progressive experience in Clinical trial oversight, Clinical coordination, Standard operating procedures, ICH GCP and GLP regulations in Pharmaceuticals and Biotechnology operational settings, Data collection, Quality review with minimal supervision and core experience in the areas below.

Areas of strength

ICH GCP/GLP/GTP guidelines

Proficient in Kareo and Epic

Proficient in EMR, CTMS, EDC

Excel, VLOOKUP, Microsoft Outlook, Microsoft office and pivot tables

Clinical trials, Project Management

Data collection, Quality assurance

GLP, Time management

Phlebotomy, Basic Life Support

Clinical study, Problem-solving skills

Work History

QUALITY ASSURANCE SUPERVISOR 05/2019 to 03/2020

VetfedCarenet- Veteran Administration – Rockville, MD

Provided quality and careful review of examination reports for general medical specialty exams and ensure reports are complete, consistent, and clear.

Created daily and weekly reports in preparation for key meetings.

Demonstrated a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Oversee the day-to-day operations within the department and ensured daily production schedules are met.

Serves as a technical resource or subject matter expert on methods and techniques within Quality Assurance

Conducts final review and approval of development, QC and related documentation prior to batch release approval

Serves as a technical resource for more junior employees

Worked within project teams to design training strategy for system implementation

Lead the Internal Audit and Quality Programs

QUALITY ASSURANCE SPECIALIST 02/2018 to 05/2019

Sunrise Medical – Greenbelt, Maryland.

Monitored Patient Opioid drug with Crisps and maintained physical and electronic filing systems (medical record)

Preparing and implementing quality assurance policies, quality tests and procedures.

Identifying and resolving workflow and production issues.

Addressing and discussing issues and proposed solutions with superiors.

Documenting quality assurance activities and creating audit reports.

Managed electronic health records (EHR)

Provided status updates on data entry tasks while adhering to data security and confidentiality requirements •

Ensured data integrity, accuracy, consistency and Prepared reports with statistical analysis.

Coordinated workflow related to data collection.

Ensured that electronic databases contain accurate, complete and up-to-date records of each patient

Clinician, 12/2015 to 11/2017

CHIVAR SPECIALIST HOSPITAL – Abuja City, Abuja

Utilized knowledge of drug therapy, pharmacokinetics, and disease states to assess and process adverse effects for multiple therapeutic areas

Performed triage of patient symptoms for Serious Adverse Events (SAE), Adverse Events (AE), and Non-serious Adverse Events (NSAE) for clinical trial, post marketing and literary review

Completed detailed reviews of GMP documentation associated with materials control including; specifications, inspection forms and inventory records

Worked collaboratively with the Materials Control team to release all GMP materials in a timely manner

Create and revise SOPs relating to the disposition of raw materials\\\

Responsible for reviewing and approving material specifications

Support internal audits of GMP regulated systems.

Demonstrated ability to manage process improvement projects

Maintained knowledge of GMP, GLP, GCP and GCLP expectations

Established full cycle of case processing including triage, data entry, medical coding narrative writing, and follow up for information

Worked with Program Manager, scientific director, and Research Assistants to ensure successful execution of clinical research studies related to Urology.

Educated patients about the research protocol, their roles in the protocols, and any other vital information and acts as a research case manager for the patients where appropriate.

Assisted research team to identify problems in the research design or analysis methodology and trends in patient reactions

Clinical Research Coordinator, 6/2015 to 12/2015

CHIVAR SPECIALIST HOSPITAL – Abuja City, Abuja

Verified that all patients have provided informed consent prior to entering study specific data.

Compared schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs.

Recorded accurate data by completing paper or electronic CRFs.

Resolved data queries accurately and within study specific timeframes.

Maintained adequate inventory of research supplies necessary for research activities. Ensures supplies and kits are current and safely disposes of expired/closed supplies.

Ensured regulatory binders are maintained with essential study documents.

Reported, tracked, and filed off-site Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within the required time frame dictated by the IRB of record.

Utilized the SAE reporting log to track the receipt, submission and acknowledgement of off-site SAEs per protocol.

Prepared reports, including but not limited enrollment logs which assists with institutional statistical analysis.

Completing case report forms and electronic data capture and electronic data capture for review and approval

Adhered to standards in all areas, including data collection, research protocols and regulatory reporting

Intern Clinician, 04/2014 to 5/2015

Wuse General Hospital Abuja – Abuja, Abuja

Maintained strict patient privacy and confidential patient information, taking care to meet all HIPAA guidelines and statues for data security

Assesses patient study eligibility, obtains past medical history and health status as required by the research protocol. Interacts with research participants and family members in a friendly, prompt, and caring manner, maintaining confidentiality and respect at all times.

Abstracts clinical data from medical charts and medical records.

Performs clinical and administrative procedures as necessary for study protocol - i.e. blood pressure, venipuncture, vital signs, completing case forms, answering queries, and completing regulatory documents.

Participates in preparation of new research proposals.

Coordinate and conduct patient care visits (drawing blood, collecting vital signs, performing ECG’s and processing specimens) and assure all procedures are conducted in compliance with the clinical protocol.

Clinical Research Assistant, 11/2011 to 11/2012

Lugansk State Medical University – Luhansk Oblasinaya, Luhansk

Completed, maintained and organized study documents. Accounts for study materials. This may include, but is not limited to participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s), and participation incentives.

Performed data collection by conducting research interviews.

Recruited and screens subjects for research studies. Collects baseline and follow up data from subjects.

Established and maintained database files and progress reports for studies, projects and programs. May perform data analysis and interpretation

Assisted with the preparation of manuscripts, reports, and presentations including editing and formatting documents. Distributes manuscripts and reports to all scientific collaborators as required.

Performed other duties as assigned.

Education

Global Health Project Management Health: Health, 2020 University of Washington - Seattle, WA

M.D.: Medicine, 2013 Luhansk State Medical University - Luhansk, Ukraine

Certifications GCP, Certificate Cardiopulmonary Resuscitation (CPR)/ AED + BLS HIPAA, Privacy& Data Protection, Scrum Master

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