CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "Case Report Forms"

Clinical Research Associate

SUMMARY: To apply my knowledge of FDA Good Clinical Practice guidelines/ICH guidelines, extensive site/field Clinical Director, Site Lead Study Management, in addition to my experience with various therapeutic areas of medicine, to a position as a Clinical Research Associate. AREAS OF EXPERTISE * Management * Interview candidates and either make a selection decision or recommend individuals for hire. * Able to manage multip...

Tags for this Online Resume: Clinical Research, Research, Accounting, Acquired Immune Deficiency Syndrome (AIDS), Advertising, Amazon Elastic MapReduce, Audit, Basic First Aid, BLS, Budgeting

Clinical Research - 2 Years of Experience - Near 77449

HIGHLIGHTS OF QUALIFICATIONS: * RN with close to 2-years experience in clinical trials monitoring * Knowledgeable of clinical trial procedures and approval processes. * In-depth knowledge of ICH GCP guidelines and FDA regulations * Conversant with Design and Review of case report forms (CRF) * Conversant with Site Monitoring visits (PSVs, SIVs, IMVs and COVs) to meet study expectations. * Clinical and post-marketing safety ...

Tags for this Online Resume: Direct Patient Care, DRESSING CHANGES, Medical, Patient Care, Suctioning, Surgical, Wound Care, Acquired Immune Deficiency Syndrome (AIDS), HIV, Monitoring

Director

QUALIFICATIONS: Over twenty years drug development experience ranging from pre-clinical pharmacology / toxicology to managing and directing clinical and cross functional teams in the conduct and execution of global, clinical trials. Experience includes coordinating and planning for budgeting, resourcing, drug supply, site and sponsor audits, and global regulatory submissions. Management experience includes management of in-...

Tags for this Online Resume: Data Management, Management, Nephrology, Clinical Research, Clinical Study Reports, Drafting, Oncology, Project Management, Project Manager, Protocol

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

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 Data Management - 1 Years of Experience - Near 02176

SUMMARY: 4 years of experience in working with both Sponsor and CRO industry focusing on computer systems validation, query management and clinical data management documentation. Worked on creating and handling validation master plan, data management plan, case report forms, change control and data validation specifications. Experience in validation of software's of clinical trial databases, ePRO-electronic patient reported...

Tags for this Online Resume: Documentation, CFR Part 11, Management, Test, Test Scripts, Data Management, Hematology, User Acceptance Testing, Acceptance Testing, Change Control

Clinical Regional Monitoring - 20 Years of Experience - Near 18929

Seeking an opportunity with a Pharmaceutical, Biotechnology company or CRO as a Senior Lead Clinical Research Associate, Lead CRA, CRA Manager/Trainer (Mentor) and/or CRO Oversight Monitor to employ my 27 years of clinical research monitoring, management skills and CRA mentoring as well as19 years of Respiratory/Pulmonary and Cardiopulmonary critical care clinical medicine. Clinical Research Experience: Projects/Therapeutic...

Tags for this Online Resume: Pharmaceutical, Clinical Research, Research, Rheumatology, Biomedical Industry, Pharmaceutical Industry, Cardiology, Critical Care - Neurology, Critical Care - Respiratory, Neurology, oncology, clinical, phase, gcp, protocol, trial, ich

Dental Assistant - 5 Years of Experience - Near 08820

Summary Highly skilled medical doctor with more than 15 years medical knowledge in various therapeutic area. 5 years' experience as Clinical Data Manager ensuring that data for clinical trials is properly collected, validated and clean. Diligently evaluate data, verify results and present conclusions. Excellent track record when it comes to consistent quality and reliability in carrying out research duties according to regu...

Tags for this Online Resume: Coding, Data Management, Data Quality, Database, Management, Quality, Quality Assurance, Data Analysis, Data Entry, Oracle

Clinical Research - 5 Years of Experience - Near 19128

SUMMARY * Project coordination, document management and coordination experience in a clinical health environment in pharmaceutical industry. Worked for Spark Therapeutics, Baxter, Execupharm, United BioSource (an Express script company) and Liquent (a Parexel Company) * 3 + years of experience in Regulatory Affairs supporting the compilation of regulatory submission and assisting with the publication those submissions using...

Tags for this Online Resume: Documentation, Microsoft Excel, Microsoft Office, Microsoft Outlook, CVS, Distribution, Document Management, Documentum, Documentum (Wkflow Sw), Financial

Biostatatician

Accomplishments * Complete more than 100 studies including phase I to phase IV. * In charge of 20 phase I and 4 phase III study NDA submission tasks to ensure high quality deliverables that comply regulatory electronic submission guidance * Preparation of statistical analysis plans including mock up tables * Application of statistical section of clinical trial reports * Review of protocols/case report forms/statistical anal...

Tags for this Online Resume: SAS, Statistical Analysis, Documentation, Management, Pharmaceutical, Quality, Quality Assurance, Quality Control, Batch Processing, Biomedical Industry

In Between - 5 Years of Experience - Near 500081

Career Summary * SAS Certified Base for SAS9 with more than four years of experience. * Worked on different Phases of clinical trials and I have experience in programming, SDTM, ADAM and reporting in Clinical Research using SAS environments. As a Clinical SAS * Worked on Various Complicated SDTM domains like LB, MO & OE for ophthalmoscopy studies * Understanding of the study Documents and Data (e.g. Study design and objecti...

Tags for this Online Resume: A SERIES, Active Directory Application Mode (ADAM), Base SAS, Cardiology, Clinical Research, Data Management, Documentation, Generate Reports, HyperText Markup Language, Macro (Predefined Code)