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Online Resumes with "GCP ICH"
Clinical Research - 16 Years of Experience - Near 94547
SUMMARY of QUALIFICATIONS 16 years of experience as a Clinical Research professional in Biotech and Pharmaceutical industries. Well-rounded skill, as a CRA in Clinical Operations processes, Clinical Development, Regulatory, TMF and Data Management. Skilled in data audit/review Study start up, Study conduct, Vendor management, and Site monitoring activities extensive knowledge of GCP-ICH, GLP, GMP guidelines familiar with Ex...
Tags for this Online Resume: Protocol, Assessments, Audit, Clinical Research, Documentation, Pediatrics, Research, Clinical Management, Distribution, oncology, phase, trial, clinical, protocol, pharmaceutical, gcp, ich
Clinical Research - 16 Years of Experience - Near 07052
SUMMARY: Clinical research professional with experience conducting and managing sponsor related clinical trials Phases I-IV following GCP and ICH requirements and guidelines. Clinical trial experience in various indications including Oncology (Solid Tumors, Prostate, Lymphoma and Renal Cell Carcinoma) and Cardiovascular (myocardial infarction, acute ischemic stroke, and Venous Thrombo-Embolism). Strong team player experienc...
Tags for this Online Resume: Management, Billing, Direct Patient Care, Integrate, Inventory, Inventory management, Medical, Medical Billing
Clinical Pharmacovigilance/Drug Safety - 10 Years of Experience - Near 19440
Summary Clinical Scientist/Clinical Data Analyst/Clinical Data Management/Project Coordinator/GLP auditor/Research Biologist with over 15 years experience in the pharmaceutical industry. Authored/QC review of protocols, protocol amendments, protocol clarification letters, informed consent forms, risk language, periodic safety reports (PSUR, DSUR, QSR), investigator brochures, medical monitoring plans, clinical SAE narrative...
Tags for this Online Resume: Protocol, Oncology, Audit, Monitoring, Critical Care - Neurology, ICH, Neurology, Quality Assurance, Test, Data Quality
Clinical Regional Monitoring - 20 Years of Experience - Near 18929
Seeking an opportunity with a Pharmaceutical, Biotechnology company or CRO as a Senior Lead Clinical Research Associate, Lead CRA, CRA Manager/Trainer (Mentor) and/or CRO Oversight Monitor to employ my 27 years of clinical research monitoring, management skills and CRA mentoring as well as19 years of Respiratory/Pulmonary and Cardiopulmonary critical care clinical medicine. Clinical Research Experience: Projects/Therapeutic...
Tags for this Online Resume: Pharmaceutical, Clinical Research, Research, Rheumatology, Biomedical Industry, Pharmaceutical Industry, Cardiology, Critical Care - Neurology, Critical Care - Respiratory, Neurology, oncology, clinical, phase, gcp, protocol, trial, ich
Clinical Research - 12 Years of Experience - Near 07086
EXPERIENCE Summary Write and review protocols that are in-line with the indication strategy. Conduct medical review and interpretation of efficacy and safety data from clinical trials. Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, review of Investigator Brochures, CTAs, Safety Data, Clinical Trial reports. Review and provide US feedback to protocols. Work with Clinica...
Tags for this Online Resume: Biopsy, Data Management, Management, Research, Chemotherapy, Clinical Research, Drafting, Process Improvement, Program Manager, Radiation
Physician Assistant - 16 Years of Experience - Near 01760
Summary of Qualifications Proficient in GCP, ICH and federal regulations and guidances Independently managed all aspects of clinical trial coordination from pre-initiation to close-out Consistently met extremely tight timelines through strong organizational skills and ability to prioritize Identified as key thought leader by pharmaceutical companies and other healthcare professionals Creative thinker and problem solver, det...
Tags for this Online Resume: Clinical Research, physician assistant, outpatient, Patient Education, 16 years of experience, Boston Metrowest Area
Postsecondary Teacher - 11 Years of Experience - Near 29376
CURRICULUM VITAE: Sharon Woodruff Team excellence instructor, facilitator, and trainer. Proven managerial, interpersonal, and training skills. Work History Title: Senior Clinical Research Associate Company/Location United BioSource Corporation Kansas City, MO/Regional United States Dates July 2014 - January 2015 Accountabilities Implement and monitor clinical trials for medications and devices to ensure sponsor and invest...
Tags for this Online Resume: South Carolina, Training, New Hire , Business, Education, Postsecondary, Excellence
You shouldn't have to read my entire resume to know I'm the one!
I absolutely enjoy what I do and look forward to work every week. I know there will be challenges and problems that my team and I will have to solve. I enjoy this career because every day is different. Every study requires a different amount of care and expertise/experience. I love the organization that comes with this career. I love having my own studies and organize documents according to company SOP as well as my own way...
Ideal Companies: Any Biopharma Company (start-up, or young companies) in Phase 1 or 2 of their studies
Tags for this Online Resume: Instant Messaging, Data Analysis, Document Management, Good Clinical Practices, Good Laboratory Practices, Management, Medical, Medical Terminology, Microsoft, Microsoft Excel, Data Entry, Site Feasibility, Trial Master File Audit, Trial Master File, Routine Monitoring Visits, Bilingual, IWRS Systems, DSMB, analysis of PK data from different generations of Japanese subjects, Receiving Plasma samples and storing them in freezers, Urine collection and UA testing, Phlobotemy, ECGs, Dosing, Writing Visit Reports, Query data sheets, Resolving Queries within the SOP allotted time frame, Pippetting Fluids and shipping off with appropriate courier., CRA visit matrixes, Reporting numbers and statistics to Project Manager and Operations Manager, Reviewing Source Documents and making original source documents according to procedures in the protocol, Protocol review sessions, QA sessions daily with a volunteer from each department to go over daily data and tasks to make sure none were missed, Call subjects and perform AE checks according to timelines on protocol, Send critical documents to sites directly or through CRAs as demanded., Make progress matrices of site visits and site reports, Send reminder emails for upcoming visits for CRAs and internal deliverables, Coder
Clinical Research - 0 Years of Experience
Good expertise in clinical trials and GCP ICH and FDA regulations * Ability to anticipate problems relating to projects and to develop and implement solutions Skilled with PC applications Microsoft Office Excel Outlook Oracle including patient and study databases and spreadsheets * Manage multiple projects at varying stages of completion * Effective in setting and meeting personal short- and long-term goals to complete assi...
Tags for this Online Resume: Data Analysis, ADA, Ada Programming Language, Audit, Inventory, Medical, Medical Records, Oncology, Oracle, Pathology, clinical, phase i, phase ii, clinical trials, phase iii, cro, pharmaceutical, regulatory, research
Programmer Analyst
SUMMARY * 6 years of experience as a Statistical Programmer in Clinical trials of Pharma Industry. * Expertise in SAS programming features like BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, and ODS. * Skilled in generating reports featuring various SAS procedures, like Proc Report, Proc Summary, Proc Freq, Proc Mean, Proc Transpose, Proc sort, Proc Univariate, Proc Datasets, Proc Compare, Prco SGPLOT, and Proc SQL. * ...
Tags for this Online Resume: Base SAS, Macro (Predefined Code), Proc, SAS, SAS/STAT, Statistical Analysis, Structured Query Language, Data Analysis, HyperText Markup Language, Microsoft Excel
RESEARCH ADMINISTRATION PROFESSIONAL
Dedicated Clinical Research Professional with over 10 years' progressive experience managing multiple phases of clinical research projects. Possessing advanced education, leadership, management, diplomacy and organizational leadership skills and consistently demonstrating the highest level of personal and professional standards. Seeks a varied and challenging position that will enable me to consolidate my professional exper...
Tags for this Online Resume: Oncology, Clinical Research, Diversity, Research, Consulting, Immunology, Medication Adherence, Planning, Policy Development, Strategic Planning, clinical, research, clinical trials, cro, regulatory
Clinical Research
PROFESSIONAL SUMMARY: Experienced Clinical Research Professional seeking career advancement with a CRO where I can make a positive contribution by utilizing my clinical research expertise. In-depth knowledge of clinical trial policies and procedures, study protocols, GCP guidelines, ICH guidelines, regulatory clinical trial documentation requirements, IRB documents submittal, sponsor electronic data capture systems for data...
Tags for this Online Resume: Chemotherapy, Clinical Research, Collection, Gastrointestinal, Oncology, PEDIATRIC, Protocol, Support
