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KIMBERLY D. WILLIAMS, MPH

QUALIFICATIONS

Adapt quickly in new work environments in order to maintain constant standard of proficiency and duediligence

Practice high level of detail-orientation, organization, and efficient time-management skills on consistent basisUnderstand 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 trialsfocusing 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 inpreparation 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 informationand updates for clinical project team and regional monitors via weekly meetings and shared trackingspreadsheets

Maintain applicable milestone dates, site staff contact information, and safety letter distribution in companyClinical Trial Management System for assigned sites during study start-up phase

Conduct preliminary feasibility assessments of prospective clinical trial sites by assessing electronic datacapture (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 trialAssisted 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 initiationincluding 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 withICH/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 controlof regulatory documents, clinical study supplies, safety letters and re-supply of study drug for active clinical

study sites

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Kimberly D. Williams, MPH

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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 IIIand five Phase I oncology clinical trials

Collected, processed, and maintained compliance of incoming regulatory documents including FDA 1572forms, 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 ManagementSystem (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 monitorsin 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 ofPhase III trials in the infectious disease therapeutic area

Maintained quality control of regulatory documents at the site level in accordance with ICH/GCP standardsand 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 trialsin the cardiovascular therapeutic area

Processed and tracked compliance of regulatory documents for over 200 study sites in USA and UnitedKingdom 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 researchManaged 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 reviewsScored test batteries; ensured data completeness; monitored patient compliance to protocolPrepared tables and figures for JAMA publication and conference poster presentationsUniversity Hospitals of Cleveland, Cleveland, OH

Research Assistant II, Mood Disorders Program February 2003 to June 2003

Assistant data manager for investigator-initiated clinical drug trialsConstructed SPSS databases and entered psychological assessment dataMaintained 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