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Online Resumes with "ICHGCP"
Clinical Research Professional- 20 years experience- Memphis
Clinical research professional with over 20 years of experience in both industry and academia. Responsible for all audit activities for multiple phase 1-3 clinical trials. Responsibilities include but are not limited to ICH/GCP compliance. Reviews key study documents such as protocols, informed consents, CRFs, monitor reports, and CSR. Presents protocol and GCP training at Investigator meetings. Mentors and trains junior qu...
Tags for this Online Resume: GCP, FDA submission documents, Drug safety, GLP, NDA, Auditor
Clinical In-house Monitoring - 13 Years of Experience - Near 08068
Skilled in the planning and implementation of clinical research projects in compliance with ICH-GCP, Regulatory Agencies, and company SOP. Study Start up expert. Proficient in Microsoft Office Applications, CTMS, IVRS/IWRS, INFORM, Medidata Rave. Therapeutic areas: Oncology, Cardiology, Neuroscience, Internal Medicine, including Diabetes. Participated in 3 FDA Submissions, FDA Inspection Readiness and TMF reconciliation
Tags for this Online Resume: Princeton, Study startup, In house CRA, CTA, Inform, Medidata Rave
Clinical Research - 10 Years of Experience - Near 11801
Cover Letter Rupal brahmbhatt Respected sir/madam ,, My self Rupal Patel Brahmbhatt. I was working at Synchron Research Services a leading CRO of India. I have been the part of this organization from when it was established, and still I was working with the same organization from 12 years. I have been a part of more than 700 projects as well as clinical studies including USFDA submission projects. I have face the US...
Tags for this Online Resume: MS office, GCP, SOP, CRA, ICF, CRC
Clinical Research Associate - Entry level - Waterloo
Driven, dynamic, and detail oriented. Trained in ICH/GCP guidelines to monitor clinical trial processes. Actively seeking an entry level CRA position within clinical trial programs.
Tags for this Online Resume: ICH/GCP, Clinical Research, SOPs, Case Report Forms, Microsoft Office Suite, Phases I - IV trials, Recruitment
Documentation
Seek challenging opportunity. My work experience and qualifications are diverse and include 10 years contracting to the Pharmaceutical Industry. Recently, I’ve earned applicable Clinical Trial subject matter certificates e.g., Kriger Research Group International (KRGI): Clinical Research Professional ICH/GCP – Certificate 9/2009; KRGI: Medical Terminology Program – Diploma 1/2010; Allied Schools: Pharmacy Technician Progra...
Tags for this Online Resume: Documentation
Programmer Analyst - 4 Years of Experience - Near 12200
To make a progressive career as a SAS Programmer in an esteemed organization where I can implement my experienced knowledge in the field of SAS programming for helping the growth of the organization.
Tags for this Online Resume: SAS, SAS Advance, SAS Macros, Statistical, CRO, CDISC, SDTM, ICHGCP
Clinical Research
Experienced Clinical Research Associate seeking a challenging and rewarding Clinical Research Associate (CRA) position that will utilize my clinical site monitoring and general management skills and experience to coordinate, monitor and manage all aspects of clinical trials in accordance with the ICH-GCP guidelines, FDA regulations, standard operating procedures and study protocol.
Clinical Research - 10 Years of Experience - Near M1T3N
SUMMARY: * NIH trained Study/Site Coordinator with 10 years of experience in clinical research coordination and administration. * Demonstrated ability in coordinating & implementing Network / Pharmaceutical / Investigator-driven multisite Phase I - IV clinical studies. * Adept in liaising with internal and external stakeholders.
Tags for this Online Resume: Protocol, Clinical Research Associate, Infectious Diseases, ICHGCP, Logistics of study material, Monitoring, Data Entry, Team Lead, Essential Documentation, Informed Consent, SOPs, Coordinator, Regulatory, QA/QC, Source Docmentation, CRF's, TMF, EDC, Toronto, Contracts, SAE
Clinical Regional Monitoring - 10 Years of Experience - Near 20912
20/20, Addis Ababa University (CRO), Addis Ababa, Ethiopia, March 2005 to July 2006 Senior Clinical Research Associate - Opthalmology Studies, National Blindness, Low-Vision & Trachoma * Oversaw $3.5M study across 14 regional states to explore blindness, low-vision, and trachoma demonstrated sharp organizational skills in managing team of clinical data managers verifying data, and performing systematic networking of databas...
Tags for this Online Resume: Clinical Research, Research, Protocol, Collection, Critical Care - Neurology, Management, Neurology, Oncology, Quality, Quality Assurance
Clinical Research - 12 Years of Experience - Near 78254
SUMMARY OF QUALIFICATIONS * Managed Phase I -IV and observational Clinical Research Trials for HIV/AIDS, HIV Vaccine trials, HIV and Hepatitis, Infectious Diseases, Hyperlipidemia, Diabetes, Renal CKD, Secondary Hyperparathyroidism, Vitamin D Deficiency, Diabetic Nephropathy, Allergies, Asthma, and Immunology, Hepatic therapeutical area, from HBV, HCV, Fatty Liver, Cirrhosis in the Liver, medical devices. * As an inhouse mo...
Tags for this Online Resume: PEDIATRIC, Pharmaceutical, Surgical, C Programming Language, Data Entry, Hepatitis, Hepatitis C, Research, Therapy, Cardiovascular
Clinical Research - 5 Years of Experience
Medical Doctor with Post Graduate training and Diploma in Clinical Research from AAPS Toronto * Over 14 years experience working in clinical environment. * Strong understanding of Clinical Research processes according to Study Protocols ICH/GCP
Tags for this Online Resume: Clinical Research, Management, Protocol, Research, Data Management, Good Clinical Practices, Medical, Clinical Trials, Informed Consent Forms, Study Reports, SOP, Regulatory approval
Project Manager
SUMMARY Experienced IT Software professional specialized in working with clients to understand and implement requirements and applications/systems to provide business analytics and strategic solutions in various roles as a Senior Business Analyst, Senior Project Manager, Senior SFDC Architect, Senior Program Manager/Product Manager and Senior Product Owner. Collaborate with product management, engineering and other cross-fu...
Ideal Companies: program mgnt
Tags for this Online Resume: Inventory, Support, Active Server Pages, Forecast, Forecasting, Oracle, Quality, Quality Assurance, Data Entry, Planning
