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Online Resumes with "Study Start up"
Clinical Research
I am currently exploring new opportunities where I can utilize my more than 20 years of experience to add value to the clinical research industry. My experience includes 8.5 years as a Clinical Trial Assistant, 4 years as an In-House CRA, 1.5 years as a Regional CRA, and 5 years supporting study start-up and site activation. I enjoyed managing regional clinical sites the most and want to further my career and skills in this...
Tags for this Online Resume: Protocol, Management, Documentation, Data Entry, Clinical Research, Compliance, Document Review, Research, Query resolution, Inform Consent Form, eCRF guidelines, SAE Reporting, AE Reporting, IRB Submissions, Regulatory Compliance, ICH / GCP / FDA guidelines, Database lock timelines met, Site deficiencies resloved, Patient enrollment and retention, Ongoing site education and support, Ensure lines of communication remain open, Study specific SOPs, Electronic Data Capture, InForm, Phase Forward, Medidata, BioClinica, Oracle, Siebel, Share Vault, Phlex Global, PhlexEview, Egnyte, Trial Interactive, Microsoft Word, Excel, Publisher, PowerPoint, DocuSign
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
