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Barbara Anderson Williams 303 Duncan Street Raleigh, NC 27608-2411 Phone: 919-946-1917 E-Mail: [email protected]
Education
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals December 2015
Regulatory Affairs Professionals Society Online University
Barnett International GCP Certification April 2015
Bachelor of Science in Zoology—North Carolina State University December 2009
Raleigh, North Carolina
Work Experience
Senior Clinical Trials Assistant, Quintiles (QRTP) March 2014-Present
Assist Clinical Research Associates (CRA), Clinical Project Managers (PTL) and Regulatory and Start-Up
(RSU) with accurately updating and maintaining clinical systems that track site compliance and
performance within project timelines. Systems include CTMS, InnTrax, InnFormant, ELVIS, Lilly
SharePoint sites, CIMS, InForm (multiple versions), RAVE, eTrials, and Timaeus.
Targeted information and reports for PTL’s and CRA’s from CTMS. Additional CTMS tasks include, data
entry, deviation reports, action items reports, lag time interval report, quarterly action items report,
site/subject reports, and PI/CRA reports.
Support the clinical team in the preparation, handling, distribution, filing, and archiving of clinical
documentation and reports according to the scope of work and standard operating procedures. Assist
with periodic review of study files for completeness. Tasks include uploading and filing in ELVIS,
uploading documents to Quintiles and Lilly SharePoint sites, InForm access requests, terminations, and
reports, and meeting minutes for various types of calls; escalation calls, Lilly/Quintiles joint calls, and
study team calls including PTL/CRA calls.
Operate as SME for the global data transfer from both CTMS and InnTrax to the Lilly Impact system.
Deliver data transfer error log reports and team error calls. Facilitate the globalization of the data feed
tool report and error log spreadsheet. Actively participate in data transfer error resolution between
CTA’s, PTL’s, and Lilly. Update XML file weekly containing the most up to date data that has been
transferred from Quintiles to Lilly.
Provide support for incoming CTA’s including mentor and buddy programs for all regions.
Provide data management reports for PTL’s on multiple studies. Reports include open/answered
Barbara Anderson Williams 303 Duncan Street Raleigh, NC 27608-2411 Phone: 919-946-1917 E-Mail: [email protected]
queries, missing forms, blank forms, missing signatures and SAFRNS data.
Provide guidance and support for the globalization of the CTA roles, Simplicity transition of studies,
updating processes and Quality Assurance PI reviews.
Contribute to the North American PI Discussion calls with PTL’s, CRA’s, and Quality Assurance from both
Lilly and Quintiles.
Participate in sponsor audits by preparing study documentation including CRA/site correspondence, site
visit report workbooks, eSOP’s for study personnel, and eTraining documentation for study personnel.
Act as central contact for the clinical team for designated project communications, correspondence and
associated documentation. Perform assigned administrative tasks to support team members with clinical
trial execution.
Represent the Lilly CTA’s on the CTA Forum Committee for GFR.
Contribute to the CTA newsletter committee for North America, Latin America, and AMERIT (Africa,
Middle East, Russian Federation, Israel, and Turkey).
Lead the ePAD globalization committee
Veterinary Technician Parkwood Animal Hospital 1998-2009, 2013-2014
Collect and analyze blood, urine, fecal, skin, and ear cytology samples from various species
Clinical assistance to veterinary staff; pharmaceutical assistance to clientele
Laboratory Analyst, Senior: Rockman Laboratory, Duke University 2005-2013
Independent research experiments and data analysis
Oversee and instruct laboratory personnel including post-doctoral fellows, students, and technicians
Maintain laboratory compliance with all federal protocols and regulations for general laboratory safety,
chemical use, and radiation use
Write, maintain, and update all animal protocols; communicate with IACUC
Barbara Anderson Williams 303 Duncan Street Raleigh, NC 27608-2411 Phone: 919-946-1917 E-Mail: [email protected]
Laboratory Manager: Wolf Laboratory, Duke University 2008-2013
Maintain laboratory compliance with all federal protocols and regulations for general laboratory safety,
chemical use, and radiation use
Write, maintain, and update all animal protocols; communicate with IACUC; personnel evaluations (PEP);
ordering and budget adherence
Publications
Ki-Seok Kim, Dennis Abraham, Barbara Williams, Jonathan Violin, Lan Mao, Howard Rockman. β-Arrestin
biased AT1R stimulation promotes cell survival during acute cardiac injury. Am J Physiol Heart Circ
Physiol. 2012 October 15;303(8):H1001-10.
Hara MR, Kovacs JJ, Whalen EJ, Rajagopal S, Strachan RT, Grant W, Towers AJ, Williams B, Lam CM, Xiao
K, Shemoy SK, Gregory SG, Ahn S, Duckett DR, Lefkowitz RJ. A stress response pathway regulates DNA
damage through β2-adrenoreceptors and β-arrestin-1. Nature. 2011 Aug 21; 477(7364):349-53.
References
Iris Diaz, LM QRTP
Quintiles
4820 Emperor Blvd
Durham, NC 27703
919-998-1309
Cindy Rowe, DVM
Triangle Square Shopping Center
Parkwood Animal Hospital
4849 North Carolina Hwy 55
Durham, NC 27713
919-544-7711
Howard A Rockman, MD
Duke University Medical Center
213 Research Drive
CARL Bldg Room 226, Box 3104
Durham, NC 27710
919-668-2520
