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Online Resumes with "GCP"
Clinical Research - 20 Years of Experience - Near 20882
Summary: Over 16 years managing clinical trials and data collection activities. Manage as Point of contact for sponsors, project teams, and investigational sites to facilitate clinical studies Phase I-IV. Responsible for the review and approval of case report forms, electronic data capture systems, review of protocols, implementing study procedure manuals, and monitoring plans. Additionally manage site selection, study exec...
Tags for this Online Resume: Collection, Quality Assurance, Test, Process Improvement, Project Management, Project Manager, Business Requirements, Clinical Research, Data Entry, Filing
Chief Operations Officer - 11 Years of Experience - Near 92122
SUMMARY of QUALIFICATIONS Available for remote project management and San Diego based roles leading business, clinical, compliance structures. Clinical and regulatory catalyst establishing organizational, technological and scientific intelligence, strategies and resources to ensure a profit based business and marketing environment. * Synergistic Scientific and Business acumen, proficient analytical, technical and interpreti...
Tags for this Online Resume: IVD/Medical Device, Pharmaceutical Research, RNA/DNA, Clinical Research, Operations, IND, Regulatory, Project Management, Oncology, AI, cNLP, Genomics
Quality Coordinator - 7 Years of Experience - Near 27703
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Compliance, Electrophoresis, ELISA, Good Laboratory Practices, HIV, Management, Medical, FDA Guidelines, GCP Guidelines, Regulatory Documents, Cardiovascular Clinical Research, Oncology Clinical Research
Clinical Regional Monitoring - 3 Years of Experience - Near 02649
Summary of Qualification: Proficient in clinical nursing practice Excellent interpersonal relationship building abilities Strong verbal, written and computer skills Proven problem solving and decision making ability Advanced physical assessment skills
Tags for this Online Resume: Assessments, Cardiopulmonary resuscitation (CPR), cv/pulm,wound care, neuro assessment, First Aid, Health Care Industry, Home Care/Hosp[ce, Home Health, Intensive Care, Intravenous Therapy, monitor clinical sites for compliance with GCP, computer literate
Clinical Regulatory Affairs - 20 Years of Experience - Near 55311
Summary of Specialized Skills * Design, development and conduct of device based Clinical and Pre-Clinical Research projects. * Experience in writing various clinical documents, including protocols, CERs, reports, research findings. * Design and Implementation of various Pre-clinical trials for pilot studies of various implantable technologies. * Management of scientific/animal studies and clinical projects. * Hands-on exper...
Tags for this Online Resume: Imaging, Cardiology, Integrated Development Environments, Management, Data Management, PACEMAKER, Pacemakers, Research, Clinical Research, Publications
Business Analyst
SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison be...
Tags for this Online Resume: ACD, Applications, Asset Liability Management, Asset Management, Automatic Call Distribution, Benefits, Business Analysis, Business Analyst, Business Requirements, CFR Part 11
Medical & Clinical Laboratory Technician - 6 Years of Experience - Near 60706
SUMMARY OF QUALIFICATIONS * BA and Masters Degree in Bioengineering and Biotechnology from Poland * Motivated team player, detail oriented, result focused with excellent time management and people skills * Proficient in MS-Office (Word, Excel, ) and the internet * Strong knowledge of anatomy and physiology, medical terminology, ICH GCP guidelines * Proven ability to work efficiently and effectively under pressure * Versatil...
Tags for this Online Resume: Administrative Assistant, Documentation, Patient Care, Scheduling, Therapy, Management, Pathology, Protocol, Satellites, Polish/English
Clinical Research
Areas Of Expertise * Good Clinical Practices * QC/QA Audits * IRB Submission/Standards In-House Monitoring * TMF Subject Matter Expert * eTMF System Validation Research Site Management * Cross-Functional Collaboration * Clinical Operations
Tags for this Online Resume: TMF, eTMF, CCRP, Site Management, Informed Consent, GCP, Document Management, IRB, Clinical Operations, Regulatory, Contracts, Budget
Clinical Project Manager-6 years-France
I supervised the development of several clinical projects in different therapeutics areas and in different countries (France, England, Italy, USA and Canada). I coordinated the clinical activities in respect with the budget, timeframe and regulations (SOPs, FDA-GCP and ICH guidelines). I trained CRAs, site investigators and CROs to ensure study protocol comprehension and compliance (initiation visits, co-monitoring). I plan...
Tags for this Online Resume: clinical project, oncology, dermatology, cardiology
Life Scientist - 15 Years of Experience - Near 77573
Professional Summary Strong management skills with 15+ years' experience in designing, managing and execution of scientific and clinical research projects resulting in acquiring lab funding for Principal investigators. * Confident communicator with solid track record of 9 publications in well-respected journals, one book chapter and 20+ presentations at national and international conferences. * Demonstrated ability to deliv...
Tags for this Online Resume: Documentation, Clinical Research, Management, Project Management, Research, Data Analysis, Diagnostics, Drafting, Neurological, Problem Solving, Good Clinical Practices, Project Planning, Critical Thinking, Molecular Diagnostics, Leadership, Team Player, Technical support, Presentation, Scientific writing, Immunology, Training, Neuroscience, Pharmacology, Microbiology, Parkinson's disease, CNS, Life science, Customer demonstration
Clinical Research - 7 Years of Experience - Near 10803
Qualification Highly motivated and accomplished Clinical Research Coordinator with extensive skills and experience. Nine years of experience as an Oncology research coordinator. Proven ability to manage multiple studies simultaneously. Managed phase 1b - IV protocols according to GCP and FDA guidelines. Experience as a supervisor and mentor to study coordinators across various oncology disease sites. Trained staff on study ...
Tags for this Online Resume: Appraisals, Audit, Clinical Research, Data Quality, Documentation, Management, Protocol, Quality, Quality Assurance, Recruiting
Clinical Research - 20 Years of Experience - Near 11554
SUMMARY Extensive management and technical experience with pharmaceutical companies in the areas of Quality Assurance, Quality Control, Manufacturing Support and Product Development. Back ground includes: * Risk Management * Process Improvement Projects * Clinical Investigator Site Audits GCP/GMP/PV Internal/ External Audits * Documentation audits * GMP, GCP Deviations/Investigations Change Control Management * Complaints H...
Tags for this Online Resume: Budget Preparation, Budgeting, Test, Compliance, Good Clinical Practices, Documentation, Technical Documentation, Packaging, Process Improvement
