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Online Resumes with "Trial Master File"
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
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
Associate Director Regulatory Affairs
I am seeking an opportunity to continue working in Regulatory Operations focusing primarily on eCTD submissions and document management of Regulatory, Clinical, and Quality compliance documents.
Tags for this Online Resume: Regulatory Affairs, Regulatory Operations, eCTD Submissions, Clinical Trial Master Files, Quality Assurance, Document Management
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
Not Listed - 0 Years of Experience
3-years' experience coordinating and assisting in clinical trials monitoring activities * Sound knowledge of Good Clinical Practices (ICH-GCP) and FDA regulations * Vast experience in billing and coding, data management, data entry, conducting billing practices, and other administrative tasks * Familiar with various computerized coding programs and electronic health records. * Advanced medical/scientific knowledge and medi...
Tags for this Online Resume: Insurance, Audit, Compliance, Clinical Research, Data Management, Documentation, Filing, Management, Monitoring, Research
Clinical In-house Monitoring - 17 Years of Experience - Near 08844
10+ years of proficient experience into clinical research as a Clinical research associate in pharmaceutical industries and clinical research organizations. * In-house and regional monitoring experience in Phase I, II, & III. * Capable to work as both in-house CRA and as a Regional CRA with efficiency to monitor and manage any number of sites depending on Sponsor's SOP. * Good working knowledge of GCP and ICH guidelines. (...
Tags for this Online Resume: Research, Clinical Research, Management, Quality, Quality Assurance, Quality Control, Audit, Oracle, Filing, Good Clinical Practices
