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Edward Asner Resume_Updated 20NOV2016
- 1. EDWARD R. ASNER, BA, AS 9009 Marmora Avenue Morton Grove, IL 60053 Home: 847-663-1031 Cell: 847-650-1147 edwardasner56@yahoo.com OBJECTIVE Seeking a position that utilizes the skills gained through 18 years of experience as a clinical research professional in the pharmaceutical and medical devices industries, and 13 years of experience in clinical labs. Prior experience in Data Management, Document Management, Cancer Cytogenetics, and Blood Bank. Effective communicator and proven team leader with a strong background in oncology. EDUCATION 1999 Governors State University, University Park, Illinois Bachelor of Arts, Liberal Arts 1985 Indiana University, Gary Indiana Associate of Science, Medical Technology EXPERIENCE 6/16 – Present inVentiv Health, Inc., Home Based, IL Senior Clinical Data Manager Responsibilities include: Leading and conducting all Data Management activities required for global clinical trials. Coordinating the resourcing and work of global staff assigned to the project. Providing training on procedures and systems. Creating project-related materials. Tracking project progress and issuing status reports. Ensuring the achievement of key milestones, such as completion of tasks towards final database. Attending and leading internal and external meetings. Working in RAVE databases to clean data, and using J-Review to produce metrics reports and ad hoc data reports. 9/13 – 6/16 OPKO Health, Inc., Bannockburn, IL Clinical Data Manager – Consultant (10/15 – 6/16) Clinical Data Manager (09/13 – 10/15) Responsibilities included: Participating in the development of Data Management documents such as Data Management Plans, Data Validation Plans, and CRF Completion Guidelines. Screening and interviewing new Data Management candidates.
- 2. Edw ard Asner Page 2 of 4 Training and mentoring new Data Managers and Data Coordinators. Giving presentations and running training sessions on Data management topics at corporate and interdepartmental meetings. Participating in database validation testing and user acceptance testing. Managing the freezing and unblinding of subjects in rollover studies. Working with IT to grant EDC database access to internal and site users, and maintaining records of user accounts. Creating Trial Master Files for Data Management documentation, following the DIA, “TMF-Reference-Model-3-0”, template. Working in OmniComm and DSG eCaselink 8.0 databases. Developing the training process and training form for users of the DSG eCaselink database. 01/12 – 09/13 Cepheid, Rolling Meadows, IL Clinical Data Specialist Cepheid is a medical devices company specializing in molecular diagnostics. Cepheid develops systems that facilitate rapid diagnosis of diseases through automation of PCR techniques. Responsibilities included: Creating Microsoft Access databases for Precision, Reproducibility, Beta, and Clinical trials. Generating reports necessary to confirm percent agreement results. Writing User Acceptance Testing plans for Medrio EDC databases, and performing the testing. Writing Data management Plans for Precision, Reproducibility, Beta, and Clinical trials. Managing queries and data clarifications for paper and EDC clinical trials. Generating final data listings used to prepare FDA submissions. 01/02 - 09/11 INC Research/Kendle International, Chicago, IL Senior Clinical Data Associate (6/05 – 09/2011) Clinical Data Associate II (4/04 - 6/05) Clinical Data Associate I (10/03 - 4/04) Clinical Data Associate (1/02 - 10/03) Reviewed and processed clinical trial data to ensure the accuracy and consistency of clinical databases. Promoted to Clinical Data Associate II in April 2004, and to Senior Clinical Data Associate in June 2005. Responsibilities included: Leading teams of CDAs. Training and mentoring CDAs. Developing and reviewing study processes, study documents, and tracking procedures. Participating in database validation testing and user acceptance testing. Reviewing and generating ad hoc listings, reports, and quality control documentation. CRF review and update, query resolution, and SAE, Lab, IVRS, and Coding reconciliation. Working with various databases in both paper and EDC studies, including Oracle Clinical, ClinPhone, DataTrack, and TrialBase.
- 3. Edw ard Asner Page 3 of 4 Kendle International was bought by INC Research in July 2011, and all Clinical Data Associates in the Chicago office were laid off in September 2011. 3/00 - 1/02 Pharmacia, Skokie, IL Medical Document Management Specialist Reviewed and processed regulatory documents. Approved initial study drug shipments to sites. Worked with internal research managers, Regulatory Affairs, and Clinical Research Organizations to facilitate activation of sites and patient enrollment. Distributed essential document packages to investigators and worked with their sites to retrieve correctly completed documents. 8/98 - 3/00 ICON Clinical Research, Inc., Buffalo Grove, IL Quality Control Auditor (7/99 - 3/00) Quality Control Assistant (8/98 - 7/99) Reviewed CRFs and generated queries. Wrote CRF and query processing procedures. Audited in-house documentation including monitoring files and investigator files. Archived study and office documents off site. LABORATORY 12/88 - 8/98 University of Chicago Hematology/Oncology Cytogenetics Laboratory, Chicago, IL Clinical Technologist Ten years experience in a cancer cytogenetics laboratory. Responsibilities included cytogenetic analysis of metaphase cells, culturing and harvesting patient samples and research cell lines, photomicroscopy, laboratory safety officer. 9/85 - 12/88 The Methodist Hospitals of Gary, Inc., Merrillville, IN Medical Laboratory Technician, Blood Bank Three years experience in a clinical blood bank. Responsibilities included ABO and RH blood typing, crossmatching blood, antibody screens, identification of unexpected antibodies, and phlebotomy. PROFESSIONAL CERTIFICATION Medical Laboratory Technician (ASCP) THERAPEUTIC EXPERIENCE Urinary/Endocrine Phase 3, Out Patient Secondary Hyperparathyroidism in Subjects with Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
- 4. Edw ard Asner Page 4 of 4 Skeletal/Bone Phase 1, 2, & 3, Out Patient Rheumatoid arthritis Osteoarthritis Psoriatic arthritis Ankylosing spondylitis Symptomatic gout Cardiovascular Phase 2 & 3, Out Patient Congestive Heart Failure – US Hypertension – International Anti-inflammatory Phase 2 & 3, Out Patient Chronic low back pain Post-gynecological surgery Anterior Cruciate Ligament Reconstruction Respiratory Phase 2, Out Patient Asthma Oncology Phase 1, 2, & 3, Outpatient Colorectal Adenoma Non-Small Cell Lung Cancer Soft Tissue Sarcoma Advanced Solid Tumors Renal Cell Carcinoma Advanced Breast or Prostate Carcinomas with Metastases to Bone BRAF mutation positive metastatic melanoma Gastrointestinal and other tumors Hematology Phase 2 & 3, Out Patient Paroxysmal Nocturnal Hemoglobinuria Idiopathic Thrombocytopenic Purpura Musculoskeletal Phase 3, Out Patient Duchenne Muscular Dystrophy Central Nervous System Psychiatry Phase 3, Out Patient Bipolar Disorder Major Depression Infectious Diseases Medical Devices, Pharma Phase 1b Chlamydia trachomatis Neisseria gonorrhea Group B streptococcus Flu Human papillomavirus Tuberculosis MRSA Norovirus Staphylococcus aureus Bacteremia Non-Healing Neuropathic Diabetic Foot Ulcers