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Click here or scroll down to respond to this candidateCandidate's Name
Street Address . PHONE NUMBER AVAILABLE E-mail: EMAIL AVAILABLEOBJECTIVES/PROFESSIONAL PROFILEAccomplished health care professional, dedicated and goal oriented providing solid credentials and cross functional experience in clinical research coordination and clinical medical technology is seeking to leverage her experience to establish a career in Pharmaceutical Research, Clinical Research and Clinical Diagnostic testing.A team player with strong communication, presentation, interpersonal, and research skills, highly motivated, goal orientated professional that is able to apply cultural beliefs of accountability, with risks taking to improve organization performance, team results, and trust with costumer first credo.My goal is to obtain a professional position to better promote my clinical research/coordinator experience with technical, clinical, and quality control principles, and to better develop my skills, that would allow me to make a meaningful contribution and growth to the work community of company.EDUCATIONGraduation: May 1996 Felician University Lodi,NJMajor: BiologyDegree: Bachelor of Arts & ScienceGraduation: January 2001 University of Medicine & Dentistry of New Jersey Newark, NJMajor: Clinical Laboratory Science & Medical TechnologyDegree: BS in Medical TechnologyGPA: 3.8EXPERIENCEAugust 2022-present St. Claress Hospital Denville/Dover, NJClinical Laboratory SupervisorResponsible for supervising daily operation of the clinical laboratoryProvides consultative services to the medical staff in the capacity of Technical Consultant for laboratoryOversees the section/department performance improvement program and participates in hospital interdisciplinary performance improvement initiativesResponsible for the technical and fiscal management of the section(s)Oversees the sections quality management/assurance program and ensures compliance with all regulatory and accreditation requirementsAssesses staff competency and completes performance evaluations in a timely mannerEnsures the accuracy of patient results prior to releasing or reportingDevelops, maintains and updates section policy and procedure manualsReviews quality control performance ensuring documentation of corrective actions taken when test systems deviate from the laboratorys established performance specificationsIdentifies problems that may adversely affect test performance and either correct the problem or immediately notify the, Director, or Medical DirectorPerforms a wide variety of laboratory procedures requiring independent judgment using both manual and automated methods in Hematology, Blood Bank, Chemistry, Urinalysis, Coagulation, Microbiology, Immunology, and any other discipline as introduced into the laboratoryEnsures the performance and documentation of equipment maintenance and QC daily, weekly, monthly, or as neededRecognizes age specific differences in expected results for newborns to geriatricsEnsures that the testing of proficiency testing samples are tested in the same manner as patient samples and that collaboration with other laboratories is prohibited prior to the reporting of proficiency testing results to the appropriate agenciesEnsures the currency of all laboratory policies and procedures and adheres to all department and hospital policies and procedures related to safety, infection control, emergency preparedness, and human resourcesOctober 2015-present BioReference Laboratories an OPKO Health Company Elmwood Park, NJClinical Laboratory Medical Technologist/Team Lead/Lipid Lab/Medical Technologist Auto-Chemistry I&II/Molecular Covid-19 LabClinical Manufacturer Scientist 4K-ScoreTestRoche Cobas c501, Cobas c513, Cobas c701, E-170 and Cobas -8000 Modular Series, Siemens Immulite 2000and Advia Centaur XPResponsible for reagent manufacture preparation, quality control of reagent, complete stiragePrecursor in setting up a brand new clinical testing laboratory from the scratch.Assisted with setting up and testing of new equipment for the LPP lab-lipoprotein particles- May 2015.Assisted with setting up and testing of brand new system equipment for Covid-19 testing and antibody testing- March 2020.Assisted with validation of the procedure according to all state and CAP standards.Responsible for all the aspects of study and monitoring including routine and close out of finished ready to use fully operated ready to preform testing clinical laboratory facility.Responsible for all aspects of new site management as directed in the project plans.General on-site monitoring to ensure the quality of testing, quality work by laboratory stuff that follow all of the protocols and that they received proper training, correct materials and instructions to safely preform testing.Ensured the protection of all informations and testing results of all patients according to HIPAA regulationsEnsured the integrity of the results submitted to doctors and patients by careful documentationPrepared all documentation, binders, graphs, log-books, worksheets for the accurate monitoring of the new laboratory according to company and state protocols.Assisted with all job training, mentoring and development of new employees in every step of testing and interpretation of test resultsMonthly prepared of all new reagents, dye, and calibrators including high and low level controls in the laboratory setting.Daily monitored of ThorLabs equipment for Imagining System and Eppendorf -EP-Motion 5075.Ensured that all testing is conducted according to the written instructions with accordance of criteria outlined in Standard Operating Procedures (SOPs)Knowledge and implementation of Good Laboratory Practice regulations (GLPs)Supervised purchase of all supplies and maintained equipment inventory monthly.Reviewed and evaluated quality control and quality assurance statistics data and modified manuals as needed within laboratory using standards and measured controls, plus maintained all applicable compliance with CLIA, OSHA, and safety risk-management guidelines.Presented and explained all of our testing procedure to New York Inspection Team during August 2018 and 2019 State Inspection.Assisted Senior management and directors with any documentation, process production, data and any clinical research and projectsPreformed all duties as assigned by management, such as independent work assignments and follow-up Quality Control (QC) and Quality Assurance(QA)when requestedNovember 2013-October2015 BioReference Laboratories an OPKO Health Company Elmwood Park, NJMedical Technologist/Immunochemistry/Infectious DiseasesPreformed routine and stat testing of serum, plasma and urine samples using Siemens and Roche automated immunoassay systems in immunochemistry. Completed, processed, reported and verify final laboratory results.Experience with Roche of E-170 and Cobas -8000 Modular Series, plus Siemens Immulite 2000 and Advia Centaur XP instruments with daily, weekly and monthly maintenance and troubleshooting operations followed by OSHA and College of American Pathologist (CAP) safety procedure.Assisted supervisors to validate new assays by preforming reagent parallel testing.Documented all corrective actions when procedures deviated from the established performance testing.Attended and graduated extensive training in operation and troubleshooting of Roche Cobas 8000modular analyzer series in developmental educational facility in Indianapolis.December 2010-November 2013 Bialostockie Centrum of Oncology Bialystok, PolandClinical Research Coordinator, Cancer Clinical Studies Coordination Unit (Hem/Cell research oncology/breast cancer studies)Worked on studies for patients with incurable hematological and solid tumor cancers, Lymphoma (CLL), non-Hodgkins lymphoma (NHL), CAR-T cell therapy with cell malignancies Clinical Trials.Created Pilot Coordination Program for Clinical Trials of Oncology Patients that included improvement of patients quality of life during and post clinical trials. Directed monitoring and effectiveness of entire step process starting from diagnosis, therapy and rehabilitation with structure that will support all complex steps in coordinating each patient case.Created joint consultation team of many specialists in different fields of oncology medicine trials.Present at each consultation as coordinator for specific patient and responsible for the control of the step by step process therapy and course of the treatment. As and direct coordinator coordinated all assets with administrative stuff, infusion nurses, pathologists, radiologists, research nurses and pharmacists, laboratory, sub-investigators, Pls to assure successful trial execution.Responsible and created patient protocol specific calendar, database information system regarding weekly and monthly schedules, of times and locations, as well as patient shadow charts, notes-to-file and logs in hematology/oncology trials.Responsible for all communication with doctors, chemotherapy, radiology, surgery, laboratory and any steps that is needed for individual patient.Organized all site selection visits, all site initiation visits and close out visits with CRAs from multiple CROs for CAR-T,CLL, NHLAssisted trial staff and all sponsor representatives in ensuring patient eligibilityCoordinated and reported all adverse events and serious adverse events according to protocol, IRB regulation and national regulation.January 2008-December 2010 Laboratory na Bema Bialystok, PolandMedical TechnologistTested, processed, completed, reported and verify complexity CBCD, WBC differentials, Spinal Fluid, coagulation testing, and complete urinalysis microscopic evaluation, body fluids, retic counts, chemistry, drug and alcohol testing.Maintain records of all laboratory procedures: follow all safety guidelines and policies. Knowledge of Beckman Coulters and daily maintained of all computer systems and equipment with trouble shooting QC and QA.Responsible for direct contact with pathologist, and oncology patients in cancer clinic.June 2006-June 2007 Johnson & Johnson Company Raritan, NJImmunohematology Product Support ScientistSupported all routine Ortho-Clinical Diagnostics Blood bank reagents, ID-Micro Typing System TM gel cards and reagents.Tested serological reagents and eliminated errors in reagent testing following written protocol.Assisted in reagent compatibility and stability report writing for test definition and regulatory submissions.Worked and preformed testing in pharmaceutical clean room environment.May 2000-August 2001 St. Marys Hospital Passaic, NJClinical Laboratory Medical Technologist, Generalist concentration in hematologyCompleted, evaluated, organized and verified CBCD, coagulation testing, urinalysis, chemistry, drugs, alcohol, and prostate cancer. Identifying under microscope abnormal cells on a blood slides and spinal fluid slides, Multiply Myeloma, Myelodysplastic syndrome, Lymphoma (CLL), non-Hodgkins lymphoma (NHL)Inspected, installed, operated, tested and maintained computer system and equipment with daily trouble shooting and daily QC and QA. Maintain High quality lab documentation and data archiving in accordance with SOPs.Assisted, coached and trained new co-workers and medical students in laboratory with safety protocols.THERAPEUTIC EXPERIENCEOncology: Hematologic Malignancies including-Leukemia (ALL), (AML),(CLL) with all Phase stages (Phase I, II,III)Multiple Myeloma (Phase I,II,III) and others such as Transplantation, Coagulation and Platelets disordersINTEREST & OTHERSExperienced in Database/Software Skills, Microsoft Office, Word, Power Point, LPP Thor camera software, Microsoft Excel Temple, SpectraCell Robot EpBlue software for EpMotion, JNP statistical Program, MediData, RaveLaboratory Skills: Clinical assays, Gel electrophoresis, DNS isolation/extraction, CART, Extraction and PCR Tecans, Kingfisher, AB1 and QuantStudios, lab equipment calibration and validity, proficient with pipetting and molecular biology techniquesFluent in English, Polish (ILR Level 5) and Russian (ILR Level 4).REFRENCESAvailable upon request |
