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Medical Technologist Resume

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Wayne, NJ

Summary: A Medical Technologist with an expertise in Immunogenetics and Molecular Biology with Laboratory Data Management skills within the Pharmaceutical industry.

Education:

Bachelor of Science in Clinical Laboratory Science
Specialty: Medical Technology

Professional Experience:

Confidential, Fairfield, NJ March 2008 - July 2009
EDC Developer

  • Worked closely with developmental team in the development of electronic CRF forms
  • Designed and implemented study specific eCRF's in accordance to protocol and SOP's
  • Developed and validated data/edit checks to generate/process queries and Case Report Forms
  • Developed and designed Case Report Forms based on protocol specifications
  • Ran validated edit checks programs
  • Designed clinical trial database, performed developer testing and submitted database for User Acceptance Testing
  • Developed strong management skills and worked closely in a team environment
  • Provided end user support and problem solving assistance after system deployment

Confidential, East Hanover, NJ November 2006 - May 2007
Clinical Data Manager

  • Worked closely with departmental team and CRO’s to resolve outstanding data management issues for clinical laboratory studies assigned to myself
  • Utilized PHOSCO and Integrated Review
  • Ran data listings for ad hoc error detection and data displays
  • Reviewed data entry screen designs, annotated CRF, tested derivation and validation procedures as well as performing documentation for assigned protocols
  • Performed SAE reconciliation and updated EDC modules as necessary
  • Evaluated both paper CRF and electronic CRF pages to ensure adverse events, concomitant drugs, and drug administration records were in correlation
  • Generated and resolved queries in PhosCo electronic data capture program, as well as paper CRF’s
  • Participated in study start up activities such as CRF review, edit checks and validation procedures as well as database lock activities
  • Therapeutic experience in Oncology Phase I clinical data studies

Confidential, Nutley, NJ May 2006 – October 2006
Lab Data Manager

  • Delivered Laboratory data with efficacy and in a timely fashion according to Roche SOP and industry quality standards
  • Updated normal ranges and units into the Oracle Clinical database for data review
  • Maintained laboratory data discrepancy database to ensure accurate and consistent lab data
  • Generated and resolved queries in Oracle Clinical and transferred queries into MACRO for Investigator review
  • Participated in Interim analysis activities for critical review of lab data correctness and completeness, while work closely with central lab and data management group
  • Worked closely with departmental team and CRO’s to resolve outstanding laboratory issues for clinical laboratory studies assigned to myself
  • Reviewed visit specific CRF pages in correlation to test parameters
  • Evaluated both paper CRF and electronic CRF pages to ensure visit dates, sample collection dates, and scheduled visits in chronological order
  • Therapeutic experience in Virology, Oncology and Transplant clinical data studies

Confidential, Rochelle Park, NJ December 2004 - April 2006
Medical Technologist

  • Generalist in Medical laboratory
  • Tasks included running viral marker assays such as Hepatitis A, B and C, as well as HIV
  • ABO and Rh blood typing on patients
  • Performed STAT testing such as Complete Blood Counts, Chemistry panels and various other serological assays
  • Familiar with New Jersey and New York state regulations for laboratory operations
  • Knowledge of FDA regulations and OSHA standards for clinical lab practice

Confidential, Springfield, NJ January 2002-May2004
Medical Technologist

  • Generalist in HLA laboratory
  • Familiar with Isolation and Purification techniques of DNA
  • Tasks included tissue typing potential organ recipients for HLA antigens via serological and molecular methodology including PCR
  • ABO blood typing for recipients and donors
  • Typed potential donors for HLA and cross matched with potential recipients
  • Ran STAT viral markers on potential donors
  • Screened potential recipients for HLA antibodies via ELISA and micro array methodology
  • Flow Cytometry screening for HLA antibodies via major and auto cross matching

Accreditation

  • Certified by the American Society of Clinical Pathologists October 2001

Computer

  • Experienced in Windows 2000/XP; Microsoft Word, Excel, and PowerPoint; Data management tools such as Oracle Clinical (Hyperion explorer, BRIO) database, MACRO (electronic data capture database) PHOSCO (EDC database) Medidata Rave (electronic data capture database)

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