KIMBERLY D.

WILLIAMS, MPH
QUALIFICATIONS Adapt quickly in new work environments in order to maintain constant standard of proficiency and due diligence Practice high level of detail-orientation, organization, and efficient time-management skills on consistent basis Understand value of working as team player with equal comfort and willingness to work independently Always ready to take on new challenges and responsibilities in order to increase skill-based knowledge and experience EDUCATION Drexel University, Philadelphia, PA Master of Public Health May 2012 Cumulative GPA: 3.96 Hampshire College, Amherst, MA Bachelor of Arts May 2001 Major: psychology and photography

SKILLS Certifications: ICH/GCP guidelines, HIPAA regulations, Patient Oriented Research, Patient Safety Education Programs: Proficient in all MS Office platforms; Adobe Reader; SPSS; Clinical Trial Management Systems (e.g., IMPACT); Documentum eRoom; Secure Document Exchange programs (e.g., IntraLinks On-Demand Workspaces) PROFESSIONAL EXPERIENCE Actelion Clinical Research, Inc. (contracted through Solomon Page Clinical Resource Network), Cherry Hill, NJ Senior Clinical Monitoring Associate, Study Start-Up Group August 2010 to Present Manage study start-up activities for US and Canadian sites across multiple Phase II and III clinical trials focusing on treatments for rare disease indications (e.g., pulmonary arterial hypertension, idiopathic pulmonary fibrosis) Collect and review site regulatory documents according to ICH/GCP standards and company SOPs in preparation for study site initiation including informed consent and assent forms; FDA 1572 forms; financial disclosure forms; curricula vitae; medical licenses; local laboratory certifications and reference ranges; local and central IRB submission, approval, and compliance documentation Primary sponsor contact for site staff during study start-up phase; provide continuous site status information and updates for clinical project team and regional monitors via weekly meetings and shared tracking spreadsheets Maintain applicable milestone dates, site staff contact information, and safety letter distribution in company Clinical Trial Management System for assigned sites during study start-up phase Conduct preliminary feasibility assessments of prospective clinical trial sites by assessing electronic data capture (EDC) experience and equipment capabilities in addition to patient enrollment expectations Sanofi-Aventis Pharmaceuticals US, LLC (contracted through The Judge Group, Inc.), Malvern, PA Clinical Project Assistant, Oncology Therapeutic Area August 2008 to August 2010 Primary US Clinical Project Assistant for in-house team of Phase III metastatic colorectal cancer trial Assisted with feasibility review of prospective study sites including potential patient recruitment, pharmacokinetic (pK) sample collection and freezer storage capabilities Coordinated and tracked study start-up preparation activities from site selection through site initiation including monitoring progress of electronic Case Report Form (eCRF) training, Interactive Voice Response System (IVRS) access, investigational drug shipment and pK lab kit distribution Assisted study start-up group with distribution and review of regulatory documents in accordance with ICH/GCP standards and company SOP guidelines including FDA 1572 forms; curricula vitae; medical licenses; informed consent forms; financial disclosure forms; laboratory certifications and reference ranges; local and central IRB documentation Managed and performed site maintenance phase activities including collection, distribution and quality control of regulatory documents, clinical study supplies, safety letters and re-supply of study drug for active clinical study sites

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AstraZeneca Pharmaceuticals, L.P. (contracted through The Judge Group, Inc.), Wilmington, DE Study Delivery Associate, Oncology Therapeutic Area April 2007 to August 2008 Exclusive US Study Delivery Associate for IND program, which included activities in one global Phase III and five Phase I oncology clinical trials Collected, processed, and maintained compliance of incoming regulatory documents including FDA 1572 forms, financial disclosure forms, informed consent forms, local and central IRB documentation Coordinated and tracked safety letter distribution between the CRO and investigational sites Set-up, populated and maintained compliance of the following information in the Clinical Trial Management System (IMPACT) database for six clinical trials: US and global safety letter distribution; IRB and health authority approval of protocol and amendments; recruitment data and event date milestones at study, country and site levels Developed and led records management training for CRO clinical staff and regional clinical research monitors in order to ensure compliant regulatory document collection and distribution Wyeth Pharmaceuticals (contracted through MedFocus LLC), Collegeville, PA Study File Analyst, Clinical Trial Logistics Department February 2007 to April 2007 Conducted internal audits of regulatory documentation for international sites in preparation for site closure of Phase III trials in the infectious disease therapeutic area Maintained quality control of regulatory documents at the site level in accordance with ICH/GCP standards and company SOPs AstraZeneca Pharmaceuticals, L.P. (contracted through The Judge Group, Inc.), Wilmington, DE Study Delivery Associate, Cardiovascular Therapeutic Area August 2006 to February 2007 Performed in-house clinical research monitoring duties to enable closure of Investigational New Drug (IND) program Responsible for regulatory document quality control during closeout phase of five Phase III clinical drug trials in the cardiovascular therapeutic area Processed and tracked compliance of regulatory documents for over 200 study sites in USA and United Kingdom according to ICH/GCP guidelines and company SOPs University of Pennsylvania, Philadelphia, PA Research Technician, Treatment Research Center September 2003 to August 2006 Coordinator for federally sponsored clinical trials focusing on addictions research Managed patient trial visits, recruitment and randomization procedures, including psychological assessment screenings and informed consent review sessions Collected, recorded and prepared research data as well as performing quality control reviews Scored test batteries; ensured data completeness; monitored patient compliance to protocol Prepared tables and figures for JAMA publication and conference poster presentations University Hospitals of Cleveland, Cleveland, OH Research Assistant II, Mood Disorders Program February 2003 to June 2003 Assistant data manager for investigator-initiated clinical drug trials Constructed SPSS databases and entered psychological assessment data Maintained data quality control through data queries, inter-rater reliability analyses, descriptive and outcome analyses employing both non-parametric and parametric tests Assisted with preparation of PowerPoint slides for data review meetings and conference presentations