Updated Emily Curriculum Vitae 2016CRA

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1 Curriculum Vitae Emilty R. Pierce RN OCN CCRC Contact Information 125 Brook Street Hilton, NY 14468 585-721-2599 [email protected] Registered Nurse NYS License Experience July 1, 2010-Present James P. Wilmot Cancer Institute, University of Rochester, OCN, Clinical Research Nurse/CRA Review all new research protocols to identify scope and intensity of Nursing needed and GCP. Oncology Advisory Council Subject Matter Expert for eRecord Research Protocol Translations Cancer Committee Member for Advance of Multidisciplinary Care Celgene Pregnancy Prevention Program Counselor. Lymphoma Nurse Liaison for SWOG Research Professionals Committee eRecord Research Leader ARCP Item Writer Survivorship Advisory Committee Wilmot Cancer Institute Implemented and Maintain Research Protocol translation for Beacon EMR system. Implemented and Maintain Research Protocol summary sheets for nursing website. Facilitate Nursing care in the Clinical Trials Office. Liaison between Office of Research and Project Administration (ORPA), Office of Research Accounting and Costing Standards (ORACS), Principal Investigator (PI), Industry representatives, and collaborating academic Institutions to assist in the development of and manage budgets for Industry supported Investigator-Initiated research Negotiate trial specific contract language Provide professional direction with the planning, implementation, coordination, operation and evaluation of the oncology projects in the Clinical Trials Office. Maintain a working knowledge of the area(s) of expertise by reviewing research literature and abstracts, attending pertinent meetings and seminar, participate in the preparation of regulatory approvals and study documents. Identifies and provides for scheduling of study events for patients enrolled. Maintain patient data, such as consent forms, letters, and appointment notices. Collect clinical data during all phases of care while patient is on-study, complete case report forms. Assist with study audits conducted by independent monitors and federal and governmental agencies. Prepare and collate patient study information, status reports, and updates as necessary for reporting on progress of patients enrolled in studies in order to accomplish a timely completion. Collaborate with personnel in other departments and facilities to implement patient activities. Consult regularly with attendings and fellows involved with patients enrolled on studies. Preparation of study documents and regulatory approvals. Review and/or edit study documents Nursing Education regarding study medication, procedures and Clinical Trials. July 1, 2007-July 1, 2010 University of Rochester Medical Center Rochester, New York Clinical Research Nurse/CRA, Department of Medicine, Gastroenterology & Hepatology Unit Maintain accurate source documentations for all aspects of studies. Track data as appropriate to study.

Transcript of Updated Emily Curriculum Vitae 2016CRA

Page 1: Updated Emily Curriculum Vitae 2016CRA

1 Curriculum Vitae Emilty R. Pierce RN OCN CCRC

Contact Information125 Brook StreetHilton, NY [email protected]

Registered Nurse NYS License

ExperienceJuly 1, 2010-Present James P. Wilmot Cancer Institute, University of Rochester, OCN, Clinical Research Nurse/CRAReview all new research protocols to identify scope and intensity of Nursing needed and GCP.Oncology Advisory Council Subject Matter Expert for eRecord Research Protocol TranslationsCancer Committee Member for Advance of Multidisciplinary Care Celgene Pregnancy Prevention Program Counselor.Lymphoma Nurse Liaison for SWOG Research Professionals CommitteeeRecord Research LeaderARCP Item WriterSurvivorship Advisory Committee Wilmot Cancer InstituteImplemented and Maintain Research Protocol translation for Beacon EMR system. Implemented and Maintain Research Protocol summary sheets for nursing website. Facilitate Nursing care in the Clinical Trials Office.Liaison between Office of Research and Project Administration (ORPA), Office of Research Accounting and Costing Standards (ORACS), Principal Investigator (PI), Industry representatives, and collaborating academic Institutions to assist in the development of and manage budgets for Industry supported Investigator-Initiated researchNegotiate trial specific contract languageProvide professional direction with the planning, implementation, coordination, operation and evaluation of the oncology projects in the Clinical Trials Office. Maintain a working knowledge of the area(s) of expertise by reviewing research literature and abstracts, attending pertinent meetings and seminar, participate in the preparation of regulatory approvals and study documents. Identifies and provides for scheduling of study events for patients enrolled.Maintain patient data, such as consent forms, letters, and appointment notices.Collect clinical data during all phases of care while patient is on-study, complete case report forms.Assist with study audits conducted by independent monitors and federal and governmental agencies.Prepare and collate patient study information, status reports, and updates as necessary for reporting on progress of patients enrolled in studies in order to accomplish a timely completion.Collaborate with personnel in other departments and facilities to implement patient activities. Consult regularly with attendings and fellows involved with patients enrolled on studies.Preparation of study documents and regulatory approvals. Review and/or edit study documentsNursing Education regarding study medication, procedures and Clinical Trials.

July 1, 2007-July 1, 2010 University of Rochester Medical Center Rochester, New YorkClinical Research Nurse/CRA, Department of Medicine, Gastroenterology & Hepatology UnitMaintain accurate source documentations for all aspects of studies. Track data as appropriate to study.Collect data on patients entered into the study via interviews, questionnaire completion, chart review and specimen results. Perform study visits as per study protocols.Recruit and enroll potential volunteers, explain study in detail and review, inclusion/exclusion criteria with potential candidate. Prepare and maintain documents for regulatory agencies. Participate in budget development and contract negotiation. Coordinate site visits, feasibility studies, and site assessments. Oversee entering and maintenance of data. Serve as liaison between regulatory agencies, sponsor and other research sites. Review monthly ledgers to validate charges and revenues. Submit reimbursement requests to sponsors.

2005-2007 AAIR Research Rochester, New YorkClinical Research Nurse Coordinator and recruiter for research studies in osteoarthritis, rheumatoid arthritis, asthma and immunology.

2002-2005 Highland Hospital Rochester, New YorkMed/Surg RN- acute care, cardiac, ventilator, telemetry step down unit.

Certifications Human Subjects Protection Program #74440612H, expires May, 2018Therakos Immune Cell Therapy Photopheresis System Basic Dysrhythmia Program University of Rochester/Strong HealthEpidural Catheter Certification Program Highland HospitalCertified Clinical Research Coordinator ACRP since March, 2008CLASP Certified June, 2009Celgene Pregnancy Prevention Counseling Program for Lenalidomide, Pomalidomide, Thalidomide 8/2011 ONS Chemotherapy & Biotherapy Provider/OCN Oncology Certified Nurse

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Professional LicensuresONS Chemotherapy & Biotherapy Provider expiration 7/23/2016Registered Professional Nurse, New York State #551488-1, expiration 12/2015Academy of Clinical Research Professionals ACRP since March, 2008Community Emergency Response Team (CERT) since November, 2008eRecord Oncology Charting Tools Workgroup

Professional Commitees and MembershipsJ. P. Wilmot Cancer Center Clinical Trials Office Protocol Review CommitteeWilmot Cancer Center Clinical Trials Office Data Safety Monitor CommitteeCelgene Pregnancy Prevention Counseling Program for Lenalidomide, Pomalidomide, Thalidomide 8/2011 J. P. Wilmot Cancer Center Oncology Advisory Council SME eRecord Research Protocol Translations

Continuing EducationEnvironmental Health & Safety: Lab Safety Training, University of Rochester Medical CenterConducting Clinical Trials Workshop, University of Rochester Medical CenterContinuous Learning for Administrators of Sponsored Programs (CLASP) ONS Chemotherapy and Biotherapy Course Fundamentals of Bone Marrow Transplant ONS Clinical Trials CRA Training Course SWOGInvestigator Training Course Roswell Park Cancer Center Patient Safety Certification

Research Studies July 2010-present, James P. Wilmot Cancer Center University of Rochester

Jonathan Friedberg MD, Principal Investigator, A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL).

Marcus Noel MD, Principal Investigator, An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan plus Low-Dose Gemcitabine Versus Placebo plus Low-Dose Gemcitabine in Patients with Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)

JJ, Ifthikharuddin MD, Principal Investigator, An Open-label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax® CD38) (Anti-CD38Monoclonal Antibody) in Combination with Backbone Regimens for the Treatment of Subjects with Multiple Myeloma

Paul Barr MD, Principal Investigator, Chung, Funkit MD A phase 1 trial of SGN-CD70A in patients with CD70-positive malignancies

Paul Barr, MD, Principal Investigator, A Phase 1/2 Proof-of-Concept Study of the Combination of ACP-196 and ACP-319 in Subjects with B-cell Malignancies

Eric Kim, MD, Principal Investigator, A phase I study of tetrathiomolybdate (TM) in combination with carboplatin and pemetrexed in chemo-naïve metastatic or recurrent non-squamous non-small cell lung cancer

Paul Barr MD, Principal Investigator, A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

Mohamed Tejani MD, Principal Investigator, A phase 1b, open label study of dalantercept plus sorafenib in patients with advanced hepatocellular carcinoma

Elizabeth Guancial MD, Principal Investigator, An Open-Label, Single-Arm, Phase 2 Study of Mocetinostat in Selected Patients with Inactivating Alterations of Acetyltransferase Genes in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma.

Carla Casulo MD, Principal Investigator, A Phase II, Open-label study evaluating the safety and efficacy of gdc-0199 (abt-199) plus bendamustine plus rituximab (BR) in comparison with BR alone or gdc-0199 plus rituximab (R) in patients with relapsed and refractory follicular non-hodgkin’s lymphoma

Mohame Tejani MD, Principal Investigator, Phase 1/2 study of pf-03084014 in combination with gemcitabine And nab-paclitaxel in patients with previously untreated Metastatic pancreatic ductal adenocarcinoma

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Paul Barr MD, Principal Investigator, A Phase 1 Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB040093 in Subjects with Previously Treated B-cell Malignancies

Paul Barr MD, Principal Investigator, A prospective randomized phase II trial of pazopanib (nsc #737754, ind #75648) versus placebo in patients with progressive carcinoid tumors

Paul Barr MD, Principal Investigator, open-label, non-randomized, two arm study to determine the efficacy and safety of ABT-199 (GDC-0199) in subjects with relapsed or refractory chronic lymphocytic leukemia

Aram Hezel MD, Principal Investigator, A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined With nab-Paclitaxel Plus Gemcitabine Compared With nab-Paclitaxel Plus Gemcitabine in Subjects with Stage IV Previously Untreated Pancreatic Cancer Halozyme

Mohamed Tejani MD, Principal Investigator, A Phase 2, Open Label Study of Dalantercept plus Sorafenib in Patients with Advanced Hepatocellular Carcinoma

Carla Casulo MD, Principal Investigator, a phase IB/II, open-label study evaluating the safety and pharmacokinetics of GDC-0199 (ABT-199) in combination with rituximab (r) or obinutuzumab (g) plus Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with b-cell non-hodgkin’s lymphoma (NHL) and DLBCL

Funkit Chung MD and Barr, Paul MD Principal Investigators, A phase 1 trial of SGN-CD70A in patients with CD70-positive malignancies

David Dougherty MD, Principal Investigator, A Phase 2, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma

Carla Casulo MD, Principal Investigator, A Phase 1 Dose Escalation Study of OMP-52M51 in Subjects with Lymphoid Malignancies

Mohamed Tejani MD, Principal Investigator, A randomized, double blind, placebo-controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib

David Dougherty MD, Principal Investigator, A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma

Jonathan Friedberg MD, Principal Investigator, A phase 2 single-arm, open-label study of single-agent brentuximab vedotin for front-line therapy of Hodgkin lymphoma (HL) in adults age 60 and above

Jonathan Friedberg MD, Principal Investigator, A randomized, double-blind, placebo-controlled, phase 3 study of brentuximab vedotin and CHP (A+CHP) versus CHOP in the frontline treatment of patients with CD30-positive mature T-cell lymphomas

Chung Funkit MD, Principal Investigator , A Randomized, Phase 2, Open-Label Study Evaluating Dn24-02 As Adjuvant Therapy In Subjects With High Risk Her2+ Urothelial Carcinoma

Aram Hezel MD, Principal Investigator, SWOG Ph II AZD6244 and MK-2206 vs mFOLFOX in pts w/ Metastatic pancreatic cancer post chemotherapy.

Jonathan Friedberg MD, Principal Investigator , A Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Deepak Sahasrabudhe, MD, Principal Investigator, ECOG A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon α- 2b for Resected High-Risk Melanoma

Paul Barr MD, Principal Investigator, Phase 1b, Escalating Dose Study of AVL-292, a Bruton’s Tyrosine Kinase (Btk) Inhibitor, as Monotherapy in Subjects with Relapsed and/or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom’s Macroglobulinemia

Deepak Saharabudhe, MD, A Phase 1b/2 Study of Docetaxel and Prednisone, with or without ISIS 183750 (an eIF4E Inhibitor), in Patients with Castrate-Resistant Prostate Cancer

Jane Lievseld MD, Principal Investigator, - A Phase I study of decitabine in combination with escalating doses of rapamycin in patients with relapsed or refractory acute myeloid leukemia

Paul Barr MD, Principal Investigator, An Open-Label, Multicenter, Phase Ib Trial Of GA101 (Ro5072759) In Combination With Chemotherapy In Patients With Previously Untreated Chronic Lymphocytic Leukemia

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Aram Hezel MD, Principal Investigator, A Phase 2, Double-Blind, Placebo-Controlled Study of IPI-504 and Docetaxel in Previously Treated Patients with Stage IIIB or IV Non-Small Cell Lung Cancer

Paul Barr MD, Principal Investigator , CALGB10404 ,A Genetic Risk-Stratified, Randomized Phase Ii Study Of Four Fludarabine/Antibody Combinations For Patients With Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia

Steven H. Berstein, MD, Principal Investigator, A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantle Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortezomib

Deborah, Mulford, MD, Prinicipal Investigator, Phase II study of Epratuzamab (NSC-716711) in combination with Cytarabine and Clofarabine for Patients with Relapsed or Refractory PH-negative Precusor B-Cell ALL

Jonathan Friedberg, MD., Principal Investigator, SPORE Phase I Trial of Carfilzomib (PR-171) in Combination with Vorinostat (SAHA) in Patients with Relapsed/Refractory B-Cell Lymphomas

Aram Hezel, MD, Prinicipal Investigator A Phase 1b/2 Study Evaluating IPI-926 in Combination with Gemcitabine in Patients with Metastatic Pancreatic Cancer Jane L. Liesveld, M.D., Principal Investigator, A Phase I, Dose Escalation Study of Plerixafor in Combination with Cytarabine and Daunorubicin in Patients with De Novo Acute Myeloid Leukemia

Aram Hezel, M.D., Principal Investigator, A randomized, open-label, multi-center phase II study to compare AUY922 with docetaxel or irinotecan in adult patients with advanced gastric cancer, who have progressed after one line of chemotherapy

Alok A. Khorana, M.D., Principal Investigator, Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer Patients Receiving Treatment with Gemcitabine

Jonathan Friedberg, M.D., Principal Investigator, A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects with Relapsed or Refractory Lymphoid Malignancies

Deepak Sahasrabudhe MD, Principal Investigator, Phase II Study of RO4929097 (NSC-749225) in Advanced Melanoma

Manoj Agarwal, MD, Prinicipal Investigator, A Phase II Trial of MTOR Inhibitor Everlimos RAD001 in malignant pleural Mesothelioma (MPM)

Aram Hezel, MD, Principal Investigator, A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer"

Michelle Shayne, MD, Principal Investigator, A Phase 1 Dose Escalation Study of MLN8237, an Aurora A Kinase Inhibitor, in Adult Patients with Non-Hematological Malignancies, Followed by a Phase 2 of MLN8237 in Lung, Breast, Head and Neck, or Gastroesophageal Malignancies

Charles W. Francis, MD, Principal Investigator ,A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in high risk ambulatory cancer patients

Deborah Mulford M.D., Principal Investigator ,Phase 1 dose-ranging study of Ezatiostat hydrochloride (Telintra®, TLK199 tablets) in combination with Lenalidomide (REVLIMID®) in patients with non-deletion (5q) LOW TO intermediate-1 risk Myelodysplastic Syndrome (MDS)

Deepak Sahasrabudhe, MD Principal Investigator, A Phase II, Open-Label, Controlled, Randomized Study of the CDX-1307 Vaccine Regimen as Neoadjuvant and Adjuvant Therapy in Patients with Newly Diagnosed Muscle-Invasive Bladder Cancer Expressing hCG-ß

Aram Hezel MD, Principal Investigator, A Phase III randomized, placebo controlled, double blind trial of Sorafenib plus Erlotinib vs. Sorafenib plus placebo as First Line systemic treatment for Hepatocellular Carcinoma (HCC)

Research Studies July 2007-July 2010, University of Rochester Medical Center, GI/ Hepatology Research Unit, Rochester, NY

Benedict Maliakkal MD, Principal Investigator, Drug induced liver injury network: A multi-center, longitudinal study of drug and CAM-induced liver injury.

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Lawrence, Saubermann MD, Principal Investigator, A double-blind, randomized, placebo-controlled multi-center study to assess the safety and efficacy of AST-120 in mild to moderately active Crohn’s patients with fistulas.

Lawrence, Saubermann MD, Principle Investigator, A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

Lawrence, Saubermann MD, Principal Investigator, A Phase III, multi-center, randomized, placebo controlled study to evaluate the clinical efficacy and safety of induction and maintenance therapy with Abatacept in subject’s with active Crohn’s Disease who have had an inadequate clinical response and/or intolerance to medical therapy.

Ullah, Asad MD, Principal Investigator, A study to investigate the effect of two doses of Creon on maldigestion in patients with exocrine pancreatic insufficiency due to chronic pancreatitis.

Benedict Maliakkal MD, Principal Investigator, Randomized, placebo-controlled, multi-center study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2b plus ribavirin).

Parvez Mantry MD, Principal Investigator, Evaluation of the Cellular Immune Response in Patients with anti-SLA/LP- or anti-LKM-positive Autoimmune Hepatitis.

Lawrence Saubermann MD, Principal Investigator, A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis

Benedict Maliakka MD, Principal Investigator, A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Co-infected with HIV and Hepatitis C

Research Studies 2005-2007 AAIR Research Center, 300 Meridian Center, Rochester, NY

John Condemi MD, Principal Investigator, A phase II randomized, placebo controlled clinical trial to study the safety and efficacy of Uvadex and Therakos Immune Cell Therapy Photopheresis System for patients with rheumatoid arthritis.

John Condemi MD, Principal Investigator, A multicenter, open label, continuation trial of Lymphosta-B antibody (monoclonal anti-BlyS antibody) in subjects with systemic lupus erythematosus (SLE) who completed the phase II Protocol LBSL02

John Condemi MD, Principal Investigator, 13 week , multicenter, randomized double dummy, placebo controlled parallel group trial of Lumiracoxib 100 mg in patients with primary osteoarthritis of the hip using celecoxib 200 mg qd as a positive control.

Emanuel Quaidoo MD, Principal Investigator, A randomized, double blind, double dummy, placebo-controlled, parallel-group study in patients with active rheumatoid arthritis who currently have a partial clinical response to treatment with MTX.

John Condemi MD, Principal Investigator, A 26 week, randomized, double blind, parallel group, placebo controlled, multi-center study to evaluate the effects of Omalizumab (Xolair) on improving the tolerability of specific (cluster) immunotherapy in subjects with persistent allergic asthma.

John Condemi MD, Principal Investigator, A Phase III trial assessing the efficacy and safety of Grazaz in subjects with seasonal grass pollen induced rhino conjunctivitis with or without asthma.

Emmanuel Quaidoo MD, Principal Investigator, A 52 week, randomized, double blind, parallel group, multi-center, Phase IIIB study comparing Symbicort pMDI 160/4.5mg x 2 actuations twice daily to Budesonide HFA pMDI 160mg x 2 actuations twice daily in Adult/Adolescent African American subjects with asthma.

Peter Deane MD, Primary Investigator, A randomized, double-blind, parallel-group study of Cardiovascular safety in osteoarthritis or rheumatoid arthritis patients with or at high risk for cardiovascular disease comparing celecoxib with naproxen and ibuprofen.

John Condemi MD, Principal Investigator, A multicenter, randomized, double-blind, triple dummy, placebo-controlle, parallel group assessing the efficacy of fluticasone propionate aqueous nasal spray 200mcg QD versus montelukast 10mg QD in adolescent and adult subjects with asthma and seasonal allergic rhinitis who are receiving Advair Diskus 100/50mcg BID or placebo BID.