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Online Resumes with "IRB Submissions"
Lead Regulatory
Tags for this Online Resume: Regulatory Submissions, IRB Submissions
Clinical Research - 6 Years of Experience - Near 92649
Experienced Clinical Research Professional interested in positions within the pharmaceutical or medical device industry.
Ideal Companies: inventiv, johnson & johnson, covance, covidien, peregrine
Tags for this Online Resume: Irvine, CCRP, regulatory affairs, clinical project manager, EDC, budgets , timelines, contracts and budgets
Clinical Research - 2 Years of Experience - Near 98033
Two years’ experience with clinical responsibilities for medical device companies with Class II devices – including an in-vitro molecular diagnostics device to detect infectious disease and a dermatological radiofrequency device that ablates nerves to reduce forehead wrinkles. Qualifications include leading a recruitment effort to secure 65 patients in 3 months across 5 sites, experience conducting and monitoring GCP phase ...
Tags for this Online Resume: monitoring, GCP, clinical research , Seattle, diagnostics, medical device , vendor , in-vitro
Professional Researcher - 10 Years Experience
PhD with documented success and experience in a diverse range of fields including academia, pharmaceuticals, and the medical device industry. Excellent writing, presentation and data analyses skills. Strong interpersonal skills with a remarkable ability to communicate scientific information to a diverse audience. Motivated by systems to improve human health and patient care.
Ideal Companies: Stryker, Johnson and Johnson, Glaxo Smith Kline
Tags for this Online Resume: Research, Infectious Diseases, Statistics, Medical Devices, Spine, Orthopedics, Sales, Pennsylvania, Clinical Research Manager, Biology, Immunological Assays, Client Relations, Social Media, Large-Scale Studies, Vaccines, Market Analysis, Event Planning, Sales Cycle Management, Data Analyses, qPCR, Genome Sequencing, Global Research, Journal Publications, Published Writer, Media Relations, Presenatations, Team Leadership
Clinical Research
Summary of Qualifications Clinical Research Manager, Associate, Monitor, Coordinator, with over 25 years experience in the medical field and 21 years experience in clinical trials with extensive experience in the fields of Cardiology, Electrophysiology, Neurology, Urology, Autoimmune, Respiratory, Gastroenterology, Weight Loss, Diabetes, Women's Studies, Arthritis, COPD, Gynecology, Endocrinology, Rheumatology and Stem Cell...
Tags for this Online Resume: Monitoring, Protocol, Cardiovascular, Clinical Research, Management, Pharmaceutical, Research, Therapy, Audit, Data Management, Medical Device, CRA, CTM, Clinical Trials
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 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
Quality Coordinator
Professional Summary: * Certified clinical research professional with nearly 10 years of clinical research experience in the medical device industry. I have a wide range of knowledge with site and study management having worked as an In-house/Field CRA, Lead CRA and Clinical Trial Assistant. * Conducting: Qualification, Initiation and Close-Out monitoring visits for pre and post-market trials. * Start-up activities for both...
Tags for this Online Resume: Documentation, Management, Data Management, Budgeting, Clinical Operations, Clinical Research, Collection, Compliance, Contract Negotiations, Distribution
Clinical Research Project Manager Interested in Growing with a Patient Centered Organization
My career goal is to first obtain a clinical research project manager position with an innovative, patient-centered pharmaceutical company, medical device company, clinical research organization (CRO), or medical center. Eventually, I would like to prepare to segue into international development as a Senior Director and play an integral role in developing a research infrastructure for new companies and/or those interested ...
Ideal Companies: Pfizer, AstraZeneca, Becton Dickinson, etc.
Pharma/Drug Safety (Research, Development)
Highly experienced, trained research and drug safety professional with extensive knowledge of FDA, EU and ICH regulations necessary to develop, study, and market medical drugs and devices. Public health professional with over 15 years of proven experience as a general physician, direct outpatient care and emergency medicine provider. Passionate about global health and drug safety. Adept in research, grant writing, public he...
Ideal Companies: Abbott, Medix, PRA health sciences, Catawba Research, Medpace, Acelity, Bellicum Pharmaceuticals, Covance, US Prahs, Novartis, Bayer, Integrated Resources INC, The University of Texas Sothwestern, Baylor Scott & White Health, Abbvie
Tags for this Online Resume: Public Health, Clinical Research, Data Analysis, Pharmacovigilance, FDA regulations, drug/device research and development, clinical trials, risk management, regulatory compliance, French language, Spanish language
I am a Regisered Nurse with interests and experience in Clinical Regional Monitoring and Clinical Management/Project Manager - 15 Years of Experience - Near 06512
I have a strong clinical background as a Registered Nurse prior to my joining the pharmaceutical industry. This has been beneficial in the course of my career. I have expertise in many areas and observational abilities in tracking subject safety and tolerability. I am aware of site challenges, having conducted clinical trials in large hospital settings as an RN and can be supportive and provide suggestions to sites when ch...
Ideal Companies: DOCs ICON Pfizer
Tags for this Online Resume: Clinical Research, Oncology, Immunology, Neuroscience, CRA, Registered Nurse, Clinical Manager, Data Management, Clinical Oversight, Project Management, CRO, CRO Oversight, GCP, ICH, Pharmaceutical Industry, Clinical Site Management, Compliance, Safety Management, Site Selection, Regulatory Compliance, Continuous Quality Improvement, Medical Writing, FDA Reporting, Trial Master File/eTMF, Cross-Functional Facilitation, Strategic Planning, Risk Analysis, Safety Oversight and Reporting, Data Targeted Review
Clinical Research Associate - 6 Years of Experience
Experienced Clinical Research Professional GCP and IATA certified, SOCRA Member COT certified by JCAHPO and CSA certified by NSAA with strong experience in medical communication with physicians, healthcare providers and patients. * Strong knowledge in the following areas: * Medical terminology, anatomy and physiology of the human systems and Diseases affecting the human body systems * All aspects of clinical research & Hum...
Tags for this Online Resume: Management, Data Entry, Microsoft, Microsoft Office, General Surgery, MICROSURGERY, Patient Care, Protocol, Services, Suctioning
