Project management experience Regulator... • ICH/GCP guidelines • IRB regulations and federal guidelines ... • strong attention to detail and effective... • peer reviewed journals • study protocols and statistical methods ... • electronic Medical Records • Oracle • and ability to learn new systems and dat...
Texas Oncology Cancer Center Austin, TX Aug 2011 to Apr 2013 Administrator, Regulatory AffairsTexas Oncology Cancer Center Austin, TX Aug 2009 to Aug 2011 Regulatory Affairs SpecialistPharmaceutical Product Development, Inc Austin, TX Oct 2006 to Aug 2009 Clinical Research Coordinator
Education:
The University of Texas at Austin Austin, TX 2006 B.S. in Biology
Skills:
Project management experience Regulatory management experience Staff training and development Document control and information processing Ability to create strong client relationships Strong understanding of clinical trial process, ICH/GCP guidelines, IRB regulations and federal guidelines Effective problem-solving skills, strong attention to detail and effective time management skills Excellent ability to read and understand scientific research, peer reviewed journals, study protocols and statistical methods Computer skills including working knowledge of Microsoft Office applications, electronic Medical Records, Oracle, and ability to learn new systems and databases Excellent verbal and written communication skills