R.N Data Entry
Resume:
SILVIA PETRIK, R.N. **/**/****
DEMOGRAPHIC INFORMATION
Personal Data: 812 Basswood drive
Stafford, VA 22554
ads6j2@r.postjobfree.com
Education:
****-**** ********** ******* ****** from Dr. Ivana Halka University, Czechoslovakia, Europe
1994 National Council of Examination Test for Registered Nurse
(NCLEX-RN), License# R 122570
PROFESSIONAL EXPERIENCE:
March 2020- present NIH
Research Nurse Specialist NCI
Cape fox Concentric for National Institution of Health, National Cancer Institution
Review electronic charts
• Explain complex consents
• Coordinate schedule and follow ups and presentations
• Collaborate with team of physicians
• Prepare documents for patients to start trial
March 2020- Feb 2021 Research Nurse Specialist NHLBI Astrix Technology Group for National Institution of Health, Support to National Heart, Lung, and Blood Institute Intake nurse
Review electronic charts
Explain complex consents
Coordinate schedule and follow ups and presentations. Collaborate with team physicians
Work up patient for transplant
International patients assist and communication with interpreter Obtaining specimens from different countries
Jan 2022- Present
NurseNow Staffing
Research Nurse Homecare for Coram at MD
Sep 2021- Nov 2021
Soliant Covid-19 point of testing Hagerstown, MD
• Temporary 2-month contract
Jan 2021- Jun 2021
CVS Vaccination nurse for Covid-19 at MD
• Temporary contract
May 1995- March 2020 JOHNS HOPKINS UNIVERSITY/ HOSPITAL Dec 2018 – Feb 2020 Senior Research Nurse
Department of Nephrology Johns Hopkins School of Medicine: Review charts for possible recruitment
Explain and obtain Informed Consents
Coordinate complex schedule between Research blood draws Outpatient chemotherapy, IDS pharmacy and pick up specimens for laboratory, working with schedulers and assuring correct day and time per protocols, IRB renewals, reviews
Oct 2016 – Feb 2020 Senior Research Nurse
Department of Hematology Johns Hopkins School of Medicine Review charts for possible recruitment
Explain and obtain Informed Consents
Educate patients about their diet and Coumadin intake Schedule their frequent visits
IRB renewals, reviews
Working closely with pharmaceutical companies
May 2016- Sept
2016
Endoscopy Procedure Nurse
Department of Medical Oncology Johns Hopkins University
Assist with procedures
Prep and recover patients as need it
Work with anesthesia group to assure safety
Give detail discharge instructions
May 1998 – May 2016 Clinical nurse II – Part time Johns Hopkins Hospital Float pool providing care in variety of hospital settings Surgical units; orthopedics, plastic, vascular, urology, eye clinic (post- trauma, post-surgical recovery)
Oncology: prostate cancer, bladder cancer, liver cancer- chemoembolization, colon cancer, kidney cancer, uterine cancer, breast cancer
Feb 2010- Oct 2015 Senior Research Nurse in Brain Cancer Program Department of Medical Oncology Johns Hopkins University
Coordinating complex protocols with intense
disease and enormous pressure on time and
starting treatment is essential.
Review charts for possible recruitment.
Explain and obtain Informed Consents
Coordinate complex schedule between research
blood draw and preparing all tubes and
requisitions, outpatient chemotherapy, IDS
pharmacy and pick up specimens for laboratory,
working with schedulers and assuring correct day
and time per protocols.
IRB renewals, reviews, protocol developing
Insurance clearance, SAE’s and notification to
sponsor and PI Ensures initial & ongoing eligibility of all subjects for assigned research studies
Ensures collection of pertinent data from internal
& external sources & monitors compliance with
requirements of assigned clinical trials
Evaluates outcomes of clinical trials
Designs/coordinates educational programs for
patients and families relevant to protocols
Provides ongoing education to patients and
families regarding pertinent clinical trial and
clinical management issues
Coordinates and/or presents continuing
education/in service programs for Clinical
Research Nurses, Clinical Associates,
Data Managers, and others involved in the
research process
May 2007- Feb 2010 Senior Immunology Research Nurse Department of Medical Oncology, Breast Cancer Vaccination Research
Johns Hopkins University
• Review charts for possible recruitment
• Explain and obtain Informed Consents
• Coordinate complex schedule between Research
blood draw, Outpatient chemotherapy, Gel pharmacy and pick up specimens for laboratory
• IRB renewals, reviews, protocol developing
• Insurance clearance, SAE’s and notification to
sponsor and PI Ensures initial & ongoing eligibility of all subjects for assigned research studies
• Ensures collection of pertinent data from internal
& external sources & monitors compliance with
requirements of assigned clinical trials
• Evaluates outcomes of clinical trials
• Designs/coordinates educational programs for
patients and families relevant to protocols
• Provides ongoing education to patients and
families regarding pertinent clinical trial and clinical management issues
• Participates in orientation process for new Clinical Research Nurses and Clinical Associates, including mentoring and preceptor of new staff
• Coordinates and/or presents continuing
education/in service programs for Clinical Research Nurses, Clinical Associates, Data Managers, and others involved in the research process
• Attends and participates in in-service and external trainings, workshops, conferences, and other relevant programs for professional growth and development
• Community: Collaborates with other members of
the research team in preparing study results for
presentation/publication
• Given opportunities, authors/co-authors
manuscripts for publication in the nursing literature and/or presentation at conferences related to areas of expertise
• Identifies nursing research questions related to protocol populations/issues and, with assistance,
collaboration, and appropriate financial support,
implements nursing research within departmental
priorities
• Takes advantage of opportunities to make
presentations in local community regarding research projects, areas of expertise
•
April 2000 – May 2007 Senior Transplantation Research Nurse Division of Transplantation Johns Hopkins University
• Recruiting subjects for all multi-center clinical trials and obtaining informed consents
• Coordinate daily activities related to clinical research projects
• Recording all data via Case Report Form or Electronic Data Entry
• Monitoring subjects for side effects and compliance with study drugs
• Educating subjects regarding immunosuppressant and their efficacy
• Meeting with the team on a regular basis
• Collecting, storing, and shipping of appropriate specimens
• Attending related workshops, conferences for continuing education.
• Reporting critical data SAE to sponsoring companies and also WIRB/IRB
August 1985 – July 1986 Registered Nurse
Second Women’s Clinic
Bratislava, Czechoslovakia
• Recovery room nurse
• Labor & Delivery Room nurse
• Assisted patients with high-risk pregnancies
RESEARCH TRAINING:
Nov. 2005 New Frontier in B Cell Therapies in Transplantation Feb. 2005 Dosing Strategies in renal Transplant patients- case studies Dec. 2003 Conflict of interest certificate in the Research Compliance training May 2003 Packaging and Shipment of Infectious Substances, Biological products and Diagnostic Specimens
April 2003 Clinical Research Coordinator Workshop: An Overview of Oncology Clinical
Trials, awarded 7.8 contact hours for Nursing CEU’s Mar. 2003 Certificate Of Completion “HIPPA Compliance Training” Oct. 2002 Renal Transplantation and Polyoma Virus infection: 1.0 contact hours Nov. 2001 Standardization of Blood Pressure Measurements, 3.0 contact hours May 2001 “New Direction” Coordinator Training Program, Society of Clinical Research Associates, Toronto, Canada 22.5 contact hours
May 2001 “Cardiovascular Disease and Renal Transplantation”, Tuft University School of Medicine, 1.2 contact hours April 2001 “Quality of Life Outcomes after Different Types of Transplantation”, Tuft University School of Medicine, 1.2 contact hours Dec. 2000 Certificate of Completion for “Human Subjects Research” Oct. 2000 “Small Intestine/Liver & Multi-Visceral Transplantation”, 1.2 contact hours Dec. 2000 “Regulatory Committees, Informed Consent, Ethics, and Subject Safety”, Required Lecture for NIH Grant Awards, General Clinical Research Center July 2000 Introduction to Clinical Research Course, General Research Center, Johns Hopkins Bayview Medical Center; 9 contact Hours
RESEARCH EXPERIENCE:
Nov. 1999 An Open-Label, Multicenter Study to Further Characterize the Clinical Utility and Safety of Rapamune and Cyclosporine Combination Treatment in De Novo
Renal Allograft Recipients
Sponsor: Wyeth-Ayerst 0468E1-900-US
Aug. 2000
A Comparative, Open-Label Study to Evaluate Graft Function in De Novo Renal Allograft Recipients Treated with Either a “Reduced Dose” or a
“Standard Dose” of Cyclosporine Oral Solution (Modified) or Cyclosporine Capsules (Modified) in Combination with Rapamune (Sirolimus) + Corticosteroids
Sponsor: Wyeth-Ayerst 0468E1-100154
Jan. 2001 A Randomized, Multicenter, Comparative Trial of Prograf (Tacrolimus) in Combination with Rapamune (Sirolimus) or Cell-Cept (Mycophenolate Mofetil) after Kidney Transplantation
Sponsor: Fujisawa 20-00-02
April 2001 An Open label, Concentration-Controlled, Randomized, 6-Month Study of
“Standard-Dose” Tacrolimus + Sirolimus + Corticosteroids Compared to
“Reduced- Dose” Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients.
Sponsor: Wyeth-Ayerst 0468E1 – 100539
June 2001 Open-Label, Randomized, Controlled, Multiple-Dose Study of Efficacy and Safety of BMS-224818 as Part of a Quadruple Drug Regiment in Renal Transplant Recipients.
Sponsor: Bristol- Myers Squibb IM 103-100
Feb. 2002 Routine Blood Drawing for Assessment of Pre- and Post- Transplant Status
Sponsor: Dr. James Burdick 91-03-15-10
Dec. 2002
A Phase II, Open Label, Multi-Center Study to Assess the Pharmacokinetics, Long-Term Safety and Tolerability Patient of Tacrolimus in Stable Liver
Transplant Patients Converted From a Prograf® Based Immunosuppression
Regimen to Modified Release (MR) Tacrolimus Based
Immunosuppression
Regimen Sponsor: Fujisawa Healthcare, Inc. 02-0-152 Aug. 2003
A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (tacrolimus), MMF, Modified Release (MR) Tacrolimus/MMF and Neoral® (Cyclosporine)/MMF in de novo
Kidney Transplant Recipients Fujisawa Healthcare, Inc. 02-0-158 Feb. 2004
Randomized Prospective Phase II Study Comparing Thymoglobulin® in Rapid
Discontinuation of Corticosteroids protocol with Standard Corticosteroid Therapy in Living Donor Renal Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy (Phase IV in Canada) Genzyme
Sept. 2004
A Prospective, Multicenter, Ope-Label, Randomized Study of the Safety, Tolerability and Efficacy of Certican (RAD) 1) with Simulect, Corticosteroids, and Lower Lavel Versus Higher Levels of Tacrolimus in de Novo Renal
Transplant Recipients Novartis Inc,CRAD001US09
March 2005
A Three Month, Open Label, Two Cohort Study To Investigate The Safety And
Tolerability Of Myfortic® in Combination With Neoral® or Tacrolimus in Renal Transplant Recipients With GI Intolerance Novartis CERL080AUS02 May 2005
A Facilitated Access Program to provide Everolimus (RAD) for Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation.
CRAD001 A 2401Novartis
May 2005
This is an open label, prospective, randomized, controlled, multi-center study assessing fixed dose vs concentration controlled CellCept® regimens for patients following a single organ renal transplantation in combination with full dose and reduced dose calcineurin inhibitors. ML 17225C/01265 Roche laboratories Inc.
May 2007 J0085: A Phase I Vaccine Safety and Chemotherapy Dose-Finding Trial of an Allogeneic GM-CSF-Secreting Breast Cancer Vaccine Given in a Specifically
Timed Sequence with Immunomodulatory Doses of Cyclophosphamide and Doxorubicin
May 2007
J05118: A Feasibility Study of Combination Therapy with Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine for the Treatment of HER-2/neu-Overexpressing Metastatic Breast Cancer
May 2007 J0320: Long-Term Follow-Up of Research Subjects who Received the GMCSF- secreting Allogeneic Breast Cancer Vaccine
Dec. 2008
A Safety and Bioactivity Study of Combination Therapy with Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine for the Treatment of Patients with High Risk/Metastatic HER- 2/neuOverexpressing Breast Cancer with No Evidence of Disease Sept. 2009
A Randomized, Open-Label Comparative Study of Combination TherapywithCyclophosphamide and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine With or Without Trastuzumab for the Treatment of Metastatic Breast Cancer that Does Not Over-express HER-2/neu Feb. 2010
N0603 - A Phase I/II Trial of Hydroxychloroquine in Conjunction with Radiation Therapy and Concurrent and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme
Feb.2010
N0703 - Phase I/II study of the poly (ADP-ribose) polymerase-1 (PARP-1) inhibitor BSI- 201 in patients with newly diagnosed malignant glioma Feb.2010
N0801 - A Phase I/II Trial of Temozolomide and ABT-888 in Subjects with Newly Diagnosed Glioblastoma Multiforme
Feb. 2010
N0901 - An Open Label, Phase 2 Study Evaluating the Safety and Efficacy of IMC-3G3 or IMC- 1121B in Patients with Recurrent Glioblastoma Multiforme Feb.2010
N0903 - A Phase Ib Study of Cediranib in Combination with Cilengitide in Patients with
Recurrent Glioblastoma
May 2011
N1101- A Phase I Open Label Safety Study to Evaluate the Pharmacokinetic Profile and Tolerance of Mibefradil Dose Finding in Subjects with High-Grade Glioma Undergoing Standard, Repeated Temozolomide
January 2012 J11132- Evaluation of blood-based biomarkers to assess response/progression in newly diagn high-grade glioma January 2013
J1242- Kinetics of plasma cytomegalovirus (CMV) load in new diagnosed high grade glioma undergoing stand Tx
November 2013 J1194- Ph1 study of Mebendazole in Newly Diagnosed High-Grade gliomas January 2014 J1389- Prospective evaluation of T-cell immune status in patients with newly diagnosed high grade gliomas
November 2014 N1202- Ph1 MK-1775+Rad & Temozolomide & Evaluation of Intratumoral Drug Distribution in Glioblastoma
December 2014 J1345- Quantitative MRSI to Predict Early Response to Vorinostat Therapy in Newly-Diagnosed Glioblastomas
January 2015
N1301- Pilot Study of MLN0128 in Preoperative Recurrent Glioblastoma March 2015
J1404- Randomized Ph2 Open Label Nivolumab or Nivo+Ipilimumab vs Bevacizumab in recurrent Glioblastoma
May 2015 J14108- Association of Lymphopenia in Pts Receiving External Beam Rad & Ability of Lymphocytes to repair DNA
June 2015
J14155- Brain Interstitium Temozolomide Concentration Pre and Post Regadenoson Administration
July 2015 J14166- Prospective high-dose (8 g/m2) systemic methotrexate in breast ca and leptomeningeal metastasis
July 2015
J14166- Prospective high-dose (8 g/m2) systemic methotrexate in breast ca and leptomeningeal metastasis
August 2015 J1575- Prospective Cross Sectional Study of Elevated HbA1c in At-Risk Patients with Central Nervous System Glioma
August 2015 J14168- A Safety Study of Fingolimod with Radiation and Temozolomide in Newly Diagnosed High Grade Glioma
November 2016
Efficacy and Safety of RivaroxabanProphylaxis Compared with Placebo in Ambulatory CancerPatients Initiating Systemic Cancer Therapy and at High Risk forVenous Thromboembolism
March 2017 ChaRactErization of patients following aCute venous thrOmboembolism
(VTE) and assessment of safety andeffectiveness of dabigatran etexilate
(DE) in the tReatmentand secondarY prevention of acute deep vein thrombosis(DVT) and pulmonary embolism (PE) in comparison tovitamin K antagonist (VKA) in routine clinical practice -RE-COVERY DVT/PE May 2107 Performance Evaluation CoaguChek PT Test
December 2018 Cure Glomerulonephropathy (CureGN)
December 2018 Clinical Research Study Title: A Phase 2, Proof-of-Concept, Randomized, Double-Blinded, Placebo-Controlled Study of ACH-0144471 Treatment for 6 Months in Patients with C3 Glomerulopathy (C3G)
January 2019 Ovarian reserve in post-menarchal females with sickle cell disease March 2019 A Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Study of GBT 440 Administered Orally to Patients with Sickle Cell Disease (031, 034, 037)
March 2020 Allogeneic hematopoietic stem cell transplantation for severe aplastic anemia and other bone marrowfailure syndromes using G-CSF mobilized CD34+ selected hematopoietic precursor cells co-infused with a reduced dose of non- mobilized donor T-cells
April 2020 Haplo-identical Transplantation for Severe Aplastic Anemia and Hypoplastic MDS using Peripheral
Blood Stem Cells and post-transplant Cyclophosphamide for GVHD prophylaxis
May 2020 Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS using CordIn™, Umbilical Cord BloodDerived Ex Vivo Expanded Stem and Progenitor Cells toExpedite Engraftment and Improve Transplant Outcome
Abstract: Timed Sequential Treatment With Cyclophosphamide, Doxorubicin, and an Allogeneic Granulocyte-Macrophage Colony-Stimulating Factor–Secreting Breast Tumor Vaccine: A Chemotherapy Dose- Ranging Factorial Study of Safety and Immune Activation Leisha A. Emens, Justin M. Asquith, James M. Leatherman, Barry J. Kobrin, Silvia Petrik, Marina Laiko, Joy Levi, Maithili M. Daphtary,
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