Data Quality Control

EMMA NJOKI

646-***-****

*****.*****@*****.***

EDUCATION

B. S. Biology, Northwest Missouri State University April 2007

Therapeutic Experience and Skills

• Oncology, Hematology, Neurology, Respiratory, Immunology and Endocrine/Metabolism.

• EDC proficiencies include Inform, Medidata RAVE, OC-RDC (Oracle Clinical-Remote Data Capture), and Labware Lab

Information Management System (LLIMS),

• Familiarity with commonly used Medical Terminology and good knowledge of Clinical trial Coding dictionaries MedDRA and

WHODRUG.

• Working familiarity with Oncology R.E.C.I.S.T 1.1 disease response guidelines.

• Computer Proficiencies include MS Excel, Word, PowerPoint and Outlook.

• Barnett Accreditation Certificate - Fundamentals of GCP EXAM.

Quintiles Transnational, Overland Park, KS August 2011 - Present

Clinical Data Coordinator

• Review and process clinical trial data to provide timely, accurate and quality data that meets customer needs.

• Participate in the development of the Data Management Plan (DMP), and eCRF Completion Guidelines.

• Generate and manage queries in the Electronic Data Capture (EDC) system following the review of manual listings.

• Generate and resolve queries to investigator sites for clarification of coded data terms

• Validate programmed edit checks and changes to programmed components in the User Acceptance Testing (UAT) database.

• Reconcile Serious Adverse Events (SAE’s) in the Safety Database to the SAE’s in the clinical database.

• Develop new and efficient processes for Lab Normal Range collection and recording, and train site staff

• Complete QC review of Lab Reference Ranges entered into the EDC system.

• Reconcile Central Lab vendor data.

• Assist with study start-up and database lock activities.

• Maintain sponsor meeting minutes and update Data Management action item logs.

• Ability to work well in Microsoft Outlook to maintain good communication and working relationships with Clinical Data

Management team.

Clinical Reference Laboratory, Lenexa, KS Oct 2009-July 2011

Lab Data Analyst

• Review patient lab data to ensure clean data is received for analysis and enter results into the Lab Ware LIMS (Lab Information

Management System). Troubleshoot non-compliant results.

• Research, review and resolve issues on error logs, to ensure accuracy and completeness.

• Review Lab manuals periodically to ensure the Lab reference ranges are current.

• Communicate with customers to ensure data is delivered in a timely manner.

• Document all quality control values and review any outlying data values before submitting data package for certification.

• Receive and separate samples, verify proper chain of custody, determine priority samples and perform sample extractions in

accordance with SOP’s

• Maintain and protect confidentiality of all CRL and client information, and comply with all applicable regulations

Senior Care Alzheimer’s Homes, Overland Park, KS January 08-May10

Team Leader-Certified Medication Aide

• Provide direct personal care services to residents in the home.

• Ensure that the Negotiated Service Agreement for each resident is followed, making recommendations to the Nurse in Charge

for updates every six months.

• Report significant changes to the nurse on duty regarding resident behavior problems, effect and effectiveness of medications,

changes in behavior, appetite and sleeping patterns.

• Interact with residents, families, neighbors, vendors and staff in a professional manner, document doctor’s appointments,

family outings, and other pertinent information.

• Familiarity with licensing regulations to ensure compliance with all requirements, particularly fire and safety requirements.

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