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Online Resumes with "essential regulatory documentation"
Clinical Research Associate
SUMMARY OF QUALIFICATIONS • Foreign graduate Medical Doctor and licensed RN with more than 22 years of clinical and research experience. US citizen. Fluent in English, Russian and Romanian • Extensive training in Good Clinical Practices, ICH Guidelines, SOPs through various Sponsors • In depth therapeutic and protocol knowledge as per Sponsor’s assignment. Excellent organizational and problem-solving skills.
Ideal Companies: Biotech companies
Tags for this Online Resume: research associate, biotech, CRA, Las Vegas, pharmaceutical, health
Regulatory Affairs, Clinical Research, Quality Assurance
A degreed professional with over 4 years of experience in the pharmaceutical/Biotech industry with multi-functional Regulatory, Clinical and Quality background. Demonstrated ability to expand beyond the scope of assigned responsibilities to gain proficiency in new areas. Responsibilities have ranged from managing the preparation, submission of INDs, BLAs, ANDAs/NDA, to reviewing QMS, essential regulatory documents to ensure...
Tags for this Online Resume: Regulatory Affairs, Clinical Research, FDA, GCP, GCP, ICH, GLP, Pharmaceuticals, Quality Assurance
Clinical In-house Monitoring
Tags for this Online Resume: documentation specialist, records management, clinical trial coordinator, essential regulatory documentation, inhouse clinical trial associate, clinical research support
Clinical Research - 1 Years of Experience - Near 07011
As Clinical Trails Associate and e-TMF expert, I have a solid expertise in the New Drug development process as well as a strong document management skills and experience with essential regulatory documents detail oriented, organized, quality driven and able to work in a team environment both national and international.
Tags for this Online Resume: Management, Data Queries, Metadata, CTMS- TMF
Clinical Research - 11 Years of Experience - Near 20774
My goal is to successfully coordinate both the technical and administrative details of any research assignment collaborating with the Principal Investigator to achieve study integrity and objectivity through the successful implementation and completion of protocols and procedures. Self-motivated achiever with over eight years' experience in different areas of research work including Human Participants in Research both for C...
Tags for this Online Resume: Clinical Research, Compliance, Good Clinical Practices, Health Care Industry, Health Insurance Portability And Accountability Act, HIPAA compliance, Pharmaceutical, Research, Training
