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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Hill StreetBoonton, NJ Street Address
Cell Phone PHONE NUMBER AVAILABLETHERAPEUTIC EXPERIENCEOncology: Breast; Leukemia, Lymphoma; Ovarian; Lung; Prostate; Kidney, GISTPeripheral Blood Stem Cell TransplantationDigestive System: Crohns DiseaseInfections/Parasitic Diseases: HIVDermatology: Head Lice; Hidradenitis SuppurativaRespiratory: Seasonal AllergiesWomens Health: Uterine Fibroids, IVFNervous System/Sense Organs: Multiple SclerosisMusculoskeletal: LupusImmunotherapy: aPDL1 for Lung CancerTargeted Radioactive Isotope for treatment of bone metastases in Breast CancerPROFESSIONAL EXPERIENCELabCorp/Covance, Inc. Sr. Clinical Research Associate II July 2019 - Mar 2020Contracted to MerckWas onboarded successfully to the Merck GCTO group within an abbreviated timeline due to immediate on-study needManaged the start-up of 8 unique sites, most at large university hospitals with several satellite sites.Liaised with the study start up teams and in-house regulatory teams to keep each sites trial master file audit-ready.[enter Coronavirus grounding of CRAs]IQVIA, Durham, NC Sr. Clinical Research Associate Jan 2019 May 2019Contracted to Eli LillyWas fully embedded into the Eli Lilly oncology groupPerformed site validation visits to assess the fitness of specific sites to perform Lilly protocols as writtenBrought sites from the validation stage, through the site initiation phase, to screening & enrolling eligible subjects, collecting accurate & usable data and closing out sites as needed.Craresources, Talahassee, FL Sr. Clinical Research Associate Oct 2017 Jan 2019Contracted to UroGen PharmaMonitor study sites per the current protocol monitoring plan all aspects of monitoring including regulatory review & reconciliation, IP and study supply accountability, site staff training and management, issue escalation as neededParticipated in two internal site audits, not for cause. One site I owned had no issues. The other site I inherited had several issues. I created and executed CAPA to completion.Facilitate subject recruitment & participation by way of arranging Ubers to site, and other helpful extras as neededManage and inventory site-specific IP & ancillary study suppliesProofed & edited CRFs and other site/subject-facing study documents that were not created by those whose first language is English, for use in the US and CanadaTrained & onboarded Sr. CRAs quickly (see one/do one)Performed all types of monitoring visits and worked with multiple sites from study start-up to COVProTrials, Inc, San Jose CA Sr. Clinical Research Associate Mar 2017 Jun 2017Contracted to Puma BiotechAssisted with the preparation of and/or review of synopses, protocols and amendments, and responsible for ensuring creation of ICFsResponsible for ensuring development of site-level Study Documents (e.g. reference manuals, Laboratory manuals, CRF Completion Guidelines, forms, etc.) and availability of site supplies (e.g. laboratory kits, clinical trial materials, etc.) within designated timelinesResponsible for ensuring development of, contributing to and/or writing site level project plans, including the monitoring plan for any assigned projects, drug accountability and reconciliation plansManaged site start-up activities and site initiation within given timelines.Managed drug accountability process, as applicable to resolve regarding any drug-related issues (e.g., re-test updates and documentation, drug supply updates, etc.)Produced and provided clinical research project metrics and functional department metrics as requiredPPD, Boonton, NJ Principal Clinical Research Associate July 2013-Jan 2017Contracted to GenentechWorked on two multicenter studies evaluating patients with myelofibrosis. One of the studies was in Phase II, the other was in Phase IIIWorked on a randomized, open label study for 3rd line treatment for breast cancer in the metastatic settingWorked closely with the CTM to coordinate the activities of CRAs on the project team to ensure clinical deliverables were metPerformed all duties of a Senior CRA as listed in job title belowMonitored investigator sites, with a particular ability to manage complex studies and/or challenging sites, to ensure the accuracy and validity of CRF entriesRecommended processes to Clinical Management that optimize the use of project resourcesProvided mentoring and support to less experienced members of the project team and advice on training and quality issues.Assisted colleagues with site visits and site calls, when neededServed as resource to team members with protocol, source document, CTMS, regulatory, data entry, and query resolution questions and issuesWorked with the Remote Site Monitoring ModelInventiv Health, Inc., North Chicago, IL Senior CRA October 2012 - May 2013Contracted to AbbVieWorked as monitor for four Phase II, Phase IIb, Phase III trials in Womens Health and Dermatology with responsibility for 12 investigative sites across the Northeastern U.SResearch Pharmaceutical Services, INC. (Re-branded by Merck), Ft Washington, PA Senior CRA Apr 2012 - Aug 2012Worked as monitor for four Phase II & Phase III trials in Womens Health and Allergy/Asthma with responsibility for 12 investigative sites across the Northeastern U.SMerck (Prev. Schering Plough Research Inst.), Kenilworth, NJCRA Apr 2006 - Apr 2012Worked as monitor for 10+ Phase II, &Phase III trials in Womens Health, Immunology, Infectious Diseases, Oncology, Allergy/Asthma with responsibility for up to 21 investigative sites across the Northeastern U.SSchering Plough Research Institute, Kenilworth, NJInternational Clinical Project Specialist Oct 2005 - Apr 2006Liaison for international CRAs in Europe & CanadaResponsible for trouble-shooting, procedure guidance, first contactDocumented quality review before submission to Global Regulatory AffairsReported to superiors weekly with status of all sites and identified problems/potential problemsTarget Health, Inc., New York, NY CRA Nov 2004 Oct 2005Responsible for monitoring, quality assurance and resolution of queries for research data entered into Target Health e*CRF system, a unique electronic data capture (EDC) applicationIn-house and in-field tracking of dataSite qualification and site assessmentIndividual and large group training on EDC methods and best practicesLiaison between sponsors, the FDA and research sitesResponsibilities included a Phase III dermatology NDA, a pre-market maintenance study for a new prostate cancer treatment and a large health initiative protocolNY Presbyterian Hospital Columbia CampusStudy Coordinator/Data Manager Nov 1999 Nov 2004Stem Cell Transplant, Hematology & Immunotherapy ProgramsLiaison between the FDA, the Western IRB, the CUMC IRB and up to seven principal investigatorsManaged the International Bone Marrow Transplant Registry Database for the CUMC Stem Cell Transplant ProgramCompleted case report forms, both on paper and via web-based CRF applications for investigator-initiated and sponsored studiesReviewed hospital charts of all patients on stem cell transplant and hematology protocols for the purpose of identifying previously unreported SAEsCreated consent forms and initial study submissions for review by the CUMC Protocol Research and Monitoring Committee, an NCI designated group of physiciansAPPLICABLE SKILLSRemote MonitoringRisk-based MonitoringCTMS both home-grown and commercialIVRS/IWRS both home-grown & commercialEDC home-grown, commercial Medidata RAVE, InForm, Target Health, CRF Health, BracketPatient eDiaries - eProeTMF Veeva Vault, home-grownPROFESSIONAL DEVELOPMENTScientific education classes with focus on a B.S. in Human Ecology, Rutgers University, New Brunswick, NJ, Sep 1992 to May 1997Fundamentals of Clinical ResearchEffective Business Partnerships 2005Scientific Fraud and Misconduct 2006Presentations with Power 2007Oncology Therapy Area Training 2007Good Clinical Practices 2008Allergy Therapy Area Training 2009Asthma Therapy Area Training 2009Anti-Infectives Therapy Area Training 2009/2010HIPAA training 2004 through 2013Clinical Specimen Management 2011Regulatory Document Training 2011Monitoring Basics 2005 to 2013PUBLICATIONS AND PRESENTATIONSPublications:Vahdat LT, Balmaceda C, Papadopoulos K, Frederick D, Donovan D, Sharpe E, Kaufman E, Savage D, Tiersten A, Nichols G, Haythe J, Troxel A, Antman K, Hesdorffer CS: Phase II trial of sequential high dose chemotherapy with XXX, XXX and XXX, XXX, and XXX with peripheral blood progenitor support in women with responding metastatic breast cancer, Bone Marrow Transplantation, 2002**The above study was supported in part by US Public Health Service Grant P30-CA13696-21, NCI R21CA 66244-01 and P20CA 6244-01 and Grant- in- Aid Programs of Amgen and Bristol Meyers Squibb OncologyLinda T. Vahdat, Deirdre J. Cohen, Debra Zipin, K. Steve Lo, Deborah Frederick, Diana Donovan, Erin Sharpe, David Savage, Amy Tiersten, Gwen Nichols, Andrea Troxel, Charles S. Hesdorffer: Randomized trial of low dose interleukin-2 vs. cyclosporine A and interferon- after high dose chemotherapy with peripheral blood progenitor support in women with high risk primary breast cancer**The above study was supported in part by US Public Health Service Grant P30-CA13696-21, NCI R21CA 66244-01 and P20CA 6244-01Jules T. Mitchel, MBA, Ph.D., Eva Jurewicz, BA, Katie Flynn-Fuchs, MS, Erin Sharpe, Glen D. Park, PharmD: The Role of CRAs in the Development and Implementation of Internet-Based Clinical Trial Applications: New Career Opportunities Monitor, Oct 2005.Poster Session08 MAR 2006 - Dose Ranging Study of a Non-Pesticide Lice Asphxiator for the Treatment of Head Lice, American Society for Clinical Pharmacology and Therapeutics (ASCPT) annual meetingCOMPUTER EXPERIENCEWindows XP, MS Word, PowerPoint, MS Excel, MS Access, CTMS, EDC (Inform, Phase Forward, Medidata Rave, EMR (various institutional systems), IXRS (ClinPhone)CLINICAL TRIAL EXPERIENCEPrincipal CRA:Oncology: An Open Label Assessment of Safety and Efficacy of XXX in Subjects With Primary Myelofibrosis, Post Essential Thrombocythemia-Myelofibrosis and Post Polycythemia Vera-Myelofibrosis Who Have Platelet Counts of 50 109/L to 100 109/LOncology: A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor XXX Administered Orally to Subjects with Primary Myelofibrosis (PMF), Post- Polycythemia Vera- Myelofibrosis (PPV-MF) or Post- Essential Thrombocythemia-Myelofibrosis (PET-MF)Oncology: A Study of xxx Plus xxx versus xxx Plus xxx in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2-Directed Regimens in the Metastatic SettingStudy Coordinator/Data Manager:Oncology: Study of High-Dose XXX and Autologous Stem Cell Transplantation in Patients With Primary Light Chain AmyloidosisOncology: Study of High-Dose XXX and Autologous Stem Cell Transplantation in Patients With Lupus (1 subject compassionate use)Oncology: Study of High-Dose XXX and Autologous Stem Cell Transplantation in Patients With Multiple Sclerosis (1 subject compassionate use)Oncology: Study of High-Dose XXX and Autologous Stem Cell Transplantation in Patients With Prostate Cancer (1 subject compassionate use)Oncology: Study of High-Dose XXX and Autologous Stem Cell Transplantation in Patients With Lupus (1 subject compassionate use)Oncology: Study of High-Dose XXX and Autologous Stem Cell Transplantation in Patients With Ovarian CancerOncology: XXX Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant GliomaOncology: Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute LeukemiaOncology: Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic AmyloidosisOncology: Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal CancerOncology: Phase II trial of sequential high dose chemotherapy with XXX, XXX and XXX, XXX, and XXX with peripheral blood progenitor support in women with responding metastatic breast cancerOncology: Randomized trial of low dose XXX vs. XXX and XXX after high dose chemotherapy with peripheral blood progenitor support in women with high risk primary breast cancerOncology: Randomized, blinded study of XXX to prevent mucositis in Patients undergoing high-dose chemotherapy and Peripheral Blood Stem cell TransplantationCRA I:Dermatology: Dose Ranging Study of a Non-Pesticide Lice Asphxiator for the Treatment of Head LiceCRA II:Infection/Parasitic Diseases: XXX, a XXX, Added to an Optimized Antiretroviral Therapy for Previously Treated HIVInfections/Parasitic Diseases: Efficacy and Safety of XXX in HIV-Infected Treatment-Nave SubjectsInfection/Parasitic Diseases: XXX in HIV-Treatment Experienced SubjectsInfection/Parasitic Diseases: XXX Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol XXXInfection/Parasitic Diseases: XXX in Combination Treatment With Optimized ART Regimen in Experienced SubjectsRespiratory: A Study of XXX in Participants With Grass Pollen Allergy Symptoms, With or Without AsthmaRespiratory: Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and OlderOncology: Study of XXX Versus Placebo in Subjects With Either Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)Womens Health: A Phase 3, Randomized, Double-blind, Active-controlled, Non-inferiority Trial to Investigate the Efficacy and Safety of a Single Injection of XXX to Induce Multifollicular Development for Controlled Ovarian Stimulation (COS) Using Daily XXX as a Reference in Women Aged 35 to 42 YearsWomens Health: Follow-up Protocol to Collect the Outcome and Safety of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Study P0XXX (Phase 3)Digestive System: Safety, tolerability, exploratory PD & PK data of a single dose of XXX administered IV to subjects with active Crohns DiseaseSenior CRA:Womens Health: Safety and Efficacy Pre-Menopausal Women with Heavy Uterine Bleeding and Uterine FibroidsDermatology: A Phase 3 Multicenter Study of the Safety and Efficacy of XXX in Subjects With Moderate to Severe Hidradenitis Suppurativa and currently on hormonal treatmentDermatology: A Phase 3 Multicenter Study of the Safety and Efficacy of XXX in Subjects With Moderate to Severe Hidradenitis Suppurativa and currently not on hormonal treatmentBreast Cancer: A Study of XXX Plus XXX Versus XXX Plus XXX in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic SettingUrinary Tract Urothelial Carcinoma: A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of XXX on Ablation of Upper Urinary Tract Urothelial Carcinoma |
