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Online Resumes with "GCP "
Clinical Research - 7 Years of Experience - Near 37208
Summary of Qualifications Detail-oriented, enthusiastic, and highly motivated Research Professional with 19+ years of successful experience. Diverse background encompasses research, laboratory analysis, reporting, and project/study planning and execution experience. Skilled at ensuring compliance with Standard Operating Procedures (SOP), Good Clinical Practices (GCP), and applicable policies and regulations. In-depth knowle...
Tags for this Online Resume: Instrumentation, Research, Quality, Quality Assurance, Quality Control, ISO, Toxicology, Leadership, Automation, Chemistry
Clinical Quality Assurance - 15 Years of Experience - Near 93065
Tags for this Online Resume: Audit, Project Management, Project Manager, Management, Data Management, Immunology, Process Improvement, Protocol, Research, Quality, clinical, phase, trial, gcp, protocol
Clinical Research - 12 Years of Experience - Near 32837
Profile: Clinical Research Professional with vast experience in Phases I- IV study trials in Oncology,
Tags for this Online Resume: Protocol, Good Clinical Practices, Quality Assurance, Test, Oncology, Management, Research, Clinical Research, Data Management, Phlebotomy, clinical, phase, trial, pharmaceutical, gcp, protocol, ich
Statistical Programmer - 5 years Experience - US
Summary * Certified Base Programmer for SAS 9 with 5+ years of biostatistical programming experience in CRO, hospitals, pharmaceutical, and healthcare industries. * Involved in drug development process with experience in analyzing, reporting, and reviewing pre-clinical/clinical trial data. * Good understanding of FDA submission (IND, NDA) process, clinical protocols, CRFs, CDISC (SDTM, ADaM), 21 CFR Part 11, GCP, and IRB gu...
Tags for this Online Resume: SAS, Proc, Programming, Statistical Analysis, SAP, Research, Statistics, Structured Query Language, Management, Test
Clinical Regional Monitoring
Accomplishments: * Compliance- Maintained compliance with regulatory standards. Ensuring site staff was trained and followed all guidelines set forth by the FDA. * Implementation-Implemented a new tracking system that resulted in improved query resolution. * Documentation-Ensured study sites followed ALCOA to ensure accuracy of through precise documentation. * Patient Safety-Ensured quality control through following ICH/GCP...
Tags for this Online Resume: Audit, Compliance, Data Quality, Documentation, Forth Programing Language, Good Clinical Practices, ICH, Management, Monitoring, Protocol
Clinical Research
PROFILE Decisive, action-oriented and results-focused professional offering more than 30 years of experience in the medical field with 23 years focused in clinical research. Thorough knowledge of Medicine. Ability to deal with the public in a professional, concerned manner and ability to convey a sense of confidence and trust to patients and work well with other health professionals. Knowledgeable of FDA, ICH and GCP guidel...
Tags for this Online Resume: ICH, EKG, Research, C Programming Language, Catalogs, Clinical Research, Hematology, Hepatitis, Hepatitis C, Scheduling
Clinical Research - 6 Years of Experience - Near 80918
Pursuing a challenging career in an organization where I can apply my talents and education in a medical/scientific-related field. Qualification Highlights Proficient use of Databases: iMedidata RAVE, RTOG, GOG, Inform, Oncore, CTSU, SWOG, Clincapture. Oversee RNs are strictly following X-Chart requirements of study protocols. Reviews Expectancy Reports of all associates in our department to ensure data timelines are met. R...
Tags for this Online Resume: Clinical Research, Research
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 Regulatory Affairs - 6 Years of Experience - Near 92648
QUALIFICATIONS Document-Labeling Specialist, Nov.2015 - Feb.2016 Well-versed communicator, high organizational and analytical (Contract Position Only) abilities. Work well independently and as a member of a * Creation, Revision of CGL, pre-printed labels and IFU via team. Adept in SUSARs, IRB submissions, Sponsor redlining documents and SOP standards. monitoring, and CTMS files. Efficient at handling multiple regulatory doc...
Tags for this Online Resume: R programming, Word, Excel, Adobe Photoshop, Illustrator, google analytics, github, Adobe, Data Entry, Documentation, ISO
Clinical Data Management - 8 Years of Experience - Near 07083
SUMMARY * Senior Clinical Trial Data Manager with extensive experience in domestic and global trial data management * Deep expertise leading Phase I-IV trials, across various therapeutic areas, including Oncology, Cardiology, and Diabetes. * Adept at serving as the liaison between Sponsor and CRO/BPO. * Deep familiarity with ICH / GCP guidelines. Experienced with Medidata RAVE, and Oracle platforms, and likewise, skilled in...
Tags for this Online Resume: Clinical Research, Protocol, Research, Oncology, Audit, Management, Project Management, Data Manager, Rheumatology, Trend Analysis
Associate Scientist, Biologist, Medical Technologist, Research Associate - 12 years experience - Indianapolis
Tags for this Online Resume: Cancer, Oncology, Research, ASCP, ELISA, High Performance Liquid Chromatography (HPLC), Instrumentation, Laboratory Instrumentation, Management, Medical, oncology, clinical, gcp, protocol, pharmaceutical, flow cytometry, Western Blot, Aseptic Technique, Mammalian Cell Culture
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
