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Jane Q

Clinical Regulatory Affairs - 15 Years of Experience - Near 44094

Occupation:

Clinical Regulatory Affairs

Location:

Willoughby, OH

Education Level:

Master

Will Relocate:

YES

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Recent CWRU graduate - MA in Bioethics, Clinical Research Concentration. Experienced Regulatory Affairs/Compliance Specialist (FDA, DOI, NIH, OIG, OSHA). Extensive knowledge of IRB processes, including SpartaIRB Protocol. Assisted in several CWRU IRB quality improvement and review processes. Proficient in education/training methods and electronic presentations. Extensive experience writing and monitoring policies and procedures in the compliance and regulatory fields. Compliance Project Manager skilled in breaking down organizational barriers to ensure project teams are effective. Experienced in software architecture, cloud computing, server maintenance and web development. A passion for improving processes and streamlining systems to improve data consistency and integrity. Exceptional organizational skills and business acumen.

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COMPANY POSITION HELD DATES WORKED

Qt Consultants Director Quality And Compliance Senior Compliance Auditor 2/2011 - 5/2009
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SCHOOL MAJOR YEAR DEGREE

Case Western Reserve University Bioethics 2018 Master Degree
CWRU School of Dentistry Research Ethics Practicum included on-site Research Protocol Audits 2017 Master Degree
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