Medical Manager
Resume:
DECEBAL SORIN GRIZA, MD
Glenview, IL 60025
**********@*****.***
PROFESSIONAL PROFILE
•Highly skilled, enthusiastic health-care professional with qualified, extensive experience in patient-care and clinical research study management.
•Wide and advanced comprehension of medical terminology, instructed and educated in various medical specialties and medical practice.
•Demonstrated ability to work in a complex healthcare delivery system, to readily understand, learn and apply new ideas, to develop and maintain appropriate interdisciplinary relationships in a broad spectrum of clinical subspecialties.
•Detail oriented, familiar and experienced with FDA and IRB regulatory requirements.
•Computer literate, mastering MS Office suites, SPSS and Photo editors.
•Strong planning, highly articulate with exceptional interpersonal, communication and organization skills, able to work effectively in a team environment and with individuals at all levels., home based office work experience.
•Experienced and operative in collection, retention, analysis, processing, and presentation of data for all aspects and levels of studies.
•Committed to providing a high level of service and assistance, with ability to prioritize responsibilities efficiently and to handle multiple tasks simultaneously in order to consistently meet tight deadlines
•In depth knowledge of Good Clinical Practice and International Conference of Harmonization guidance documents, as well as of Code of Federal Regulations Title 21
EDUCATION
•The University of Medicine Victor Babes Timisoara, Romania, Medical Doctor Degree 1992
•The University of Chicago Graham School of Continuing Liberal and Professional Studies.
Clinical Trials Management and Regulatory Compliance Certificate - 2012
Classes completed:
Good Clinical Practices
The Drug Development Process
Statistical Concepts for Clinical Research
Fundamentals of Clinical Monitoring
Fraud and Misconduct
Fundamentals of Site Management
•CITI Collaborative Institutional Training Initiative completed courses: 2011
Clinical Coordinators including International Research Perspective module
Good Clinical Practice including Audits and Inspection in Clinical Trials module
Health Information Privacy and Security (HIPS)
•Clinical Research Basic Training Certificate 2012
Northwestern University, Chicago
WORK HISTORY
Clinical Research Coordinator March 2011 – July 2012
The Cancer Institute at Alexian Brothers Hospital Network
800 Biesterfield Rd. Elk Grove Village Illinois
Duties and responsibilities:
•Assisted with preparation of protocols, informed consents, amendments and other necessary documents for review by the IRB and sponsor.
•Identified with respect to inclusion criteria, consented and enrolled eligible subjects on studies.
•Followed and reported adverse events (AEs, SAEs) to IRB and sponsors.
•Scheduled study subject's visits, labs and procedures, processed and shipped lab samples according to protocols.
•Created, prepared and updated case report forms, trial master files, trial subject files and source documents.
•Completed clinical data capture forms, entered data electronically via web based systems, and
submitted clinical data to study statistical centers.
•Attended at and participated in clinical research training meetings and interdisciplinary conferences
•Processed epidemiological data collected within the clinics, prepared and performed PowerPoint presentations.
•Acted as a liaison between various entities involved and participated in clinical research, from sponsors and CRO, medical monitors, project managers and CRAs, to local and central IRBs, investigators, pharmacists and medical staff.
Office Manager
Nov. 2009 - Feb. 2011
Dr. Diana Racean - 3412 Main Street, Skokie, IL 60076
Duties and responsibilities:
•Scheduled and confirmed patients appointments, handled patient reception, managed business and patient records, processed patients insurance, handled marketing and advertisement for the office
•Collected and recorded patient health histories, organized and maintained patients charts updated.
•Overseen account receivables and account payables, acted as the liaison between insurance companies and the office for submitting claims and receiving payments.
•Contacted the patients to schedules appointments and to explain the treatment plan that the doctor has decided upon.
Resident Physician in Family Medicine
July 2008 - Oct. 2009
Lutheran General Hospital, Park Ridge, IL
Duties and responsibilities:
•Managed patients of all ages with various diagnoses in different settings, took medical history,
•Performed clinical exams and various medical procedures, ordered treatment and tests as needed, participated at morning reports and teaching rounds of each rotation.
Clinical Trials Manager - Hektoen Institute of Medical Research,
May 2003 - July 2008
Cook County Hospital Hektoen Institute of Medical Research, Chicago, IL
•At the division of Hematology and Oncology at Cook County Hospital I have initiated, organized and developed the clinical study site, activated and managed both industries sponsored and in house studies, assisted with the protocols and regulatory documents, managed the budgets of clinical trials and grants.
STUDIES DIRECTED AS CLINICAL TRIALS MANAGER / RESEARCH COORDINATOR:
At Hektoen Institute of Medical Research at Cook County Hospital
•Phase II Study of PS-341 for Patients with High-Risk, Newly Diagnosed Multiple Myeloma. ECOG E2A02.
•Microarray Analysis of Patients with Diffuse Large B-cell Lymphoma treated with CHOP/Rituximab. Sponsor: University of Nebraska.
•EXamination of PNH, by Level Of CD59 on REd and white blood cells, in bone marrow failure syndromes (EXPLORE). Sponsor: Alexion Pharmaceuticals.
•EMBRACE: The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol.
Sponsor: Alexion Pharmaceuticals.
•A Phase 2 Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled, Parallel Group Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients with Chronic Idiopathic Thrombocytopenic Purpura (ITP). Sponsor: AkaRx, Inc.
•Protocol Number: 501-CL-004 - A Phase 2, Double-Blind, Randomized, Parallel Group, Rollover Study of AKR-501 in Patients with Chronic Idiopathic Thrombocytopenic Purpura (ITP) Who Responded to Study Treatment in Protocol 501-CL-003. Sponsor: AkaRx, Inc.
•Paroxysmal Nocturnal Hemoglobinuria (PNH) Subject Registry. Sponsor: Alexion Pharmaceuticals / Ovation.
•Protocol CAMN107A2109: An Open-Label, Multi-Center, Expanded Access Study of Oral AMN107 in Adult Patients With Imatinib (Glivec®/Gleevec®) -Resistant or -Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase. Sponsor: Novartis.
•CML World Registry- 2008. Sponsor Novartis/Parexel.
•A randomized, Open-label, Multi-Center trial comparing Thalidomide plus Dexamethasone (Thal-Dex) versus DOXIL plus Thalidomide plus Dexamethasone (DOXIL Thal-Dex) in subjects with Newly Diagnosed Multiple Myeloma; IRB# 05-027. Sponsor: Tibotec / Orthobiotec
•The Hematopoietic Stem Cell in Polycythemia Vera. Sponsor: University of Illinois at Chicago 12. Characterization of the Hematopoietic Stem Cell in Patients with Idiopathic Myelofibrosis. Sponsor: University of Illinois at Chicago
At Alexian Brothers Cancer Institute
•ECOG E1505 A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients with Completely Resected Stage IB 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC) •CALGB 30607 Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511, IND #74019) as Maintenance Therapy in Non-Progressing Patients following an Initial Four Cycles of Platinum- Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer
•REO021: A Phase 2 Study of Intravenous Administration of REOLYSIN® (Reovirus Type 3 Dearing) in Combination with Paclitaxel and Carboplatin in Patients with Squamous Cell Carcinoma of the Lung Stg III/IV
•CALGB C80405: A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum.
•NSABP P-5: Statin Polyp Prevention Trial in Patients with Resected Colon Cancer Resected Stage I/II
•REO018: Randomized, Double-blind, Multicenter Two-Stage Adaptive Phase 3 Study of Intravenous Administration of REOLYSIN® (Reovirus Type 3 Dearing) in Combination with Paclitaxel and Carboplatin versus the Chemotherapy Alone in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck who have Progressed on or after Prior Platinum-Based Chemotherapy
•CALGB C10404: A Randomized Phase II Study of Three Fludarabine /Antibody Combinations for Patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia PIX 306: A Randomized Multicenter Study Comparing Pixantrone + Rituximab with Gemcitabine + Rituximab in Patients with Aggressive B-cell NHL Who Have Relapsed after Therapy with CHOP-R or an Equivalent Regimen and are Ineligible for Stem Cell Transplant
•INCYTE 424 Randomized, open label, multicenter phase III study of Efficacy and Safety in POlycythemia vera subjects who are resistant to or intolerant of hydroxyurea: JAK iNhibitor INC424 tablets verSus bEst available care (The RESPONSE Trial)
•E1609 A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon -2b for Resected High-Risk Melanoma
•Registry Caris Life Sciences: TCREG-001-00-V2-1209 "A Registry of the Target Now® Test Results (Biomarker Expression Patterns) and Hematopoietic Diagnostics for Evaluation of Correlation with Clinical Outcomes for Cancer and Other Patients."
RESULTS OF RESEARCH ACTIVITY
Oral presentations:
•2004 Review of Hematology Oncology out-patient data Griza D, Catchatourian R. Division of Hematology and Oncology, Jon H. Stroger, Jr. Hospital of Cook County, Chicago, IL. Analysis of visits and patients with hematologic malignant and nonmalignant diagnosis at Hem/Onc and Hematology Clinics.
•2006 A Two-Month View of the Chemoinfusion Center at John H Stroger Hospital, Griza D, Shah M, Catchatourian R. Division of Hematology and Oncology, Jon H. Stroger, Jr. Hospital of Cook County, Chicago, IL. Analysis of the demographic data gathered during the Quality of Life evaluation of cancer patients receiving chemotherapy in the infusion center over a period of two months.
•2007 Quality of Life Aspects in Patients receiving Chemotherapy at the Infusion Center at Stroger Hospital (Powerpoint Presentation.). Griza D, Shah M, Catchatourian R. Division of Hematology and Oncology, Jon H. Stroger, Jr. Hospital of Cook County, Chicago, IL. Analysis of questionnaires filled by the patients undergoing chemotherapy at the Infusion Center at Stroger Hospital. Questions were related to the side effects of chemotherapy and were filled out by patients at every session of chemotherapy to highlight its impact on the overall quality of life and functionality of the patients. This information was used to analyze how chemotherapy affected QOL.
•2012 Identifying Patients - Best Practices, Sorin Griza, MD. Cell Therapeutics PIX-306 Study - Training Investigators and Coordinators meeting, Las Vegas. Presented to sponsor, investigators, and coordinators prescreening process of the research subjects at Alexian Brothers research department using EMR and IDC9 codes.
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