Quality Control Assurance

IRENE N. UCHE

*** ********* ******, ***** – NJ **638 – 609-***-**** – ***********@***.***

CLINICAL DATA COORDINATOR

PROFESSIONAL EXPERIENCE

PHARMANET INC., Princeton, New Jersey 06/1999 – 10/2009

Quality Control Associate II 06/2008 – 10/2009

Quality Control Associate I 02/2007 – 06/2008

• Performed Quality Control on sample listing for programmers to produce SAS listings for data review

• Performed QC of data entry and verification, laboratory normal ranges and eCRFs

• Performed rolling, interim and final QC inspections of the clinical study database

• Performed data review and quality assurance, query generation and resolution, dictionary coding and database validation

• Assisted in creation of a Data Management plan for each clinical project which describes procedures and decisions required for the data processing of the studies involved in the project

• Performed EDC data review and assisted in collecting and maintaining project metrics

• Coordinated QC activities of QC Associates I on assigned projects and others in the department

• Attended project team meetings on QC activities and interacted with other departments on QC issues

Associate Clinical Data Analyst 06/2005 – 02/2007

• Performed data review and quality assurance, query generation and resolution, dictionary coding, and database validation

• Identified study specific data management procedures, processes and operations

• Maintained study specific project documentation in accordance with Global Data Management Plans

Senior Clinical Data Technician 06/2002 – 06/2005

• Functioned as a Lead Data Technician for one or more projects

• Tracked and coordinated progress of Case Report Form (CRF) receipt and entry

• Identified issues affecting quality and timeliness of project completion and implemented solutions

• Prepared, maintained and communicated data entry conventions and other study-specific issues

• Trained other data entry staff on entry procedures and systems

• Completed all quality control measures necessary for the finalization and transfer of the database and related materials to the client

• Created data entry screens and performed data entry testing of clinical trial database

• Identified achievement of milestones such as database approval for entry and data entry completion

Clinical Data Technician 06/1999 – 06/2002

• Entered data from CRFs into the database and functioned as a primary Data Technician for projects

• Verified data entered into the clinical database by performing second entry and resolving discrepancies

• Tracked and coordinated progress of CRF receipt and entry

• Identified issues affecting quality and timeliness of project completion and implemented solutions

• Prepared, maintained and communicated data entry conventions and other study issues

THERAPEUTIC BACKGROUND

Cardiovascular, Dermatology, Arteriosclerosis, Parkinson Disease, Rheumatoid Arthritis, Asthma, Acne, Erectile Dysfunction, Topical Ocular Anesthesia, Inflammatory Bowel Disease, Upper Respiratory, Hypertension, Headache/Migraine, CHD, Ulcerative Colitis, Breast Cancer, Anti-fungal Disease, Non-renal Failure, Juvenile Rheumatoid Arthritis, Ablation Cathether – Cardiac, LDL Cholesterol, Weight loss

EDUCATION

MCCC, Trenton, New Jersey – AS, Respiratory Therapy (Current Student)

COLLEGE OF EDUCATION, Owerri, Nigeria – AS, Data Administration

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