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)
