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Online Resumes with "SAE Reporting"



Clinical Regional Monitoring - 17 Years of Experience - Near 46321

SUMMARY OF CLINICAL EXPERIENCE Eleven years' experience as a CRA which includes 2 years as a Lead CRA in clinical trial monitoring, including study start up, study initiation through closeout, as well experience in International, and Domestic studies. Provide on-site clinical trial monitoring and full site management at investigational sites in the conduct of Phase II-IV clinical trials. Recruited and trained CRA (s), inves...

Tags for this Online Resume: Data Management, Gastroenterology, Management, Patient Education, Pharmaceutical Industry, Start up, Clinical Research, Research

Clinical Regional Monitoring - 3 Years of Experience - Near 0000

PROFESSIONAL SUMMARY Clinical Research Professional with various project experience from concept to development. Talents include in-depth knowledge of ICH guidelines SAE reporting and GCP auditing. Integral team-player with excellent communication skills CORE QUALIFICATIONS * Patient Recruitment & Screening * Detailed Documentation * Serious Adverse Event Reporting * Communicating with IRB for study proposal, approval and u...

Tags for this Online Resume: Clinical Research, Data Entry, Research, Audit, Communication Skills, Compliance, Documentation, Excellent Communication Skills, Good Clinical Practices, ICH

Clinical Research

PROFILE Decisive, action-oriented and results-focused professional offering more than 30 years of experience in the medical field with 23 years focused in clinical research. Thorough knowledge of Medicine. Ability to deal with the public in a professional, concerned manner and ability to convey a sense of confidence and trust to patients and work well with other health professionals. Knowledgeable of FDA, ICH and GCP guidel...

Tags for this Online Resume: ICH, EKG, Research, C Programming Language, Catalogs, Clinical Research, Hematology, Hepatitis, Hepatitis C, Scheduling

Featured Profile

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