Deborah D. Hamilton 4301 Edgehill Ct. Raleigh, NC 27612

Research professional with 15 years’ experience in all areas.

UCB Biosciences Inc. formerly Schwarz Biosciences Inc.Sept 2007 to PresentSr. CTA: Sept 2008 to Present CTA: Sept 2007 to Sept 2008

Assists clinical trial team(s) to manage trials efficiently and to the required regulatory standards especially with document management and tracking, including set-up and maintenance of Trial Master Files. Maintain and update trial tracking tools/lists (e.g. Clinical Trial Management System) and trial budget spreadsheets.

A Senior CTA may be assigned to more complex studies than a CTA. The role includes all the activities of a CTA, as well as an expectation for a higher level of performance. Additionally he/she will provide mentoring to more junior CTA team members. The CTA is assigned to one or more clinical studies with annual budgets up to 15 million Euros owned by project teams. Maintains trial budget spreadsheets and tracks expenditure against budget for one or more trials. Tracks invoice payments due to investigators/vendors based on financial agreements and related milestones.

Sales: Influences future sales through contribution to overall quality of trials. Contributes to good relationships between UCB and investigators (present/future customers) by promoting prompt and efficient interactions including timely payment of invoices. Participate in clinical study team meetings and may participate in Investigator Meetings, CSM Training meetings or other trial-related meetings as appropriate with the preparation, distribution and filing of agenda, minutes and meeting materials as required. Preparation of trial-related documents, tools and templates, including newsletters. Maintain and update information in trial tracking tools, lists and/or systems, as well as trial status report and overviews and with review and assembly of regulatory packages for trial-related submissions to Regulatory Authority and IRB/IECs, in accordance with ICH GCP, applicable regulations and Company SOPs. Set-up, maintain and manage TMF in collaboration with the ACPM and TMF personnel as they are responsible for ongoing and final QC checks of TMF. The flow of information starts with the Sr. CTA and goes to Study Team and CSMs and/or Vendors, as applicable; Between UCB and Investigator Site personnel; e.g. sending and requesting documents, channeling requests for supplies, problems or questions to the appropriate team member. Provides the reconciliation of investigator/vendor invoices against previous payments, achieved milestones and contractual agreements and with the processing and tracking of invoices and payments as well as maintenance and tracking of study budget(s). Timely and effective communication of safety reports as required to team members.

i3 Research, Cary, NC Senior Project Research Associate September 2006- August 2007

Manage study process to ensure adherence to protocol, SOPs, GCP/ICH Guidelines, applicable regulatory requirements, and other documentation requirements, including: Verify study documents (e.g., case report forms, source documents, adverse events) are reviewed and tracked for completeness and accuracy. Review, clarify, and obtain data changes via query with site personnel and lead team members in reviewing data listings and writing queries. Draft, compile and verify clinical data for status reports when required. Track and manage the distribution of study drug and clinical supplies as requested. Assist in the development of study timelines and ensure compliance with study timelines. Assist with the management of vendors and associated data. Assist the Project Manager and Lead Clinical Research Associate (CRA) in preparing the necessary tools to maintain consistency in the study data across all sites and CRAs. Convey project information and answer questions. Troubleshoot, advise, and follow up on study progress with site staff and customer. Monitor vendors and other service providers for quality of service. Prepare key reports and documents on progress of study for Project Manager and customer review. Review report data for completeness and accuracy. Ensure process is in place for accurate and complete project files. Maintain clinical trial management system information pertaining to the study and serve as eClinical resource for project team members. Verify and monitor adherence to the regulatory document collection process and Safety Monitoring Plan. Interact as functional lead with data management, safety, regulatory personnel, and other functional groups, as appropriate. Review data listings, participate in query process, and liaise with data management to ensure completion of all activities in preparation for database lock, when indicated.

DCRI, DURHAM, NC Clinical Trials Assistant II, Site Management November 2004-September 2006

Maintain and update database for study-related documents and to include weekly and other reports as requested. Review of documents in compliance with regulations, ensure study materials are shipped and supplied as requested. Track all in USD, as well as update spreadsheet. Work with sites to complete revisions as needed. Attend meetings with attention to any changes. Communicate with staff updates on sites for implementation and problem resolution. Adhere to guidelines and Standard Operating Procedures. Work with new staff members and assist them with the transition by giving them tools to expedite the process for documentation. Work with the monitors to ensure they have all documents and lists of things needed from the site for accurate record keeping. Track and file trip reports, work with PM Network to assure sites get all supplies needed. Assist sites with IVRS problems and drug shipments. Assist Contracts with negotiation as well as collect and process IRB invoices for submission, approval and renewals as needed.

QUINTILES INC., DURHAM, NC S ite Startup Coordinator, Site ID

March 2003-October 2004

Provide all necessary support in identifying and selecting investigators, and in completing the collation of all required documentation necessary so that investigational product can be shipped to sites in advance of patient enrollment in a given trial. This includes contract negotiation, regulatory documents and approvals in a fast track situation. After this has been completed, all documents are tracked in Intraxx. Work with IRBs as needed in the approval process. Collect and process IRB invoices for submission, approval and renewals as needed.

PPD DEVELOPMENT, MORRISVILLE, NCClinical Research Associate 1January 2003- March 2003

Participate in site selection and in training site personnel regarding the trial; perform in house monitoring duties and follow-up to ensure identified deficiencies are corrected. Assist in assessing the suitability of potential investigative sites through telephone screening interviews, regulatory document review and collecting clinical trial information; conduct site qualification calls to determine adequacy of facilities and staff, patient recruitment and retention potential, ability to comply with regulatory requirements, and overall interest and commitment of principal investigator to conduct and complete the planned clinical study. Conduct monitoring calls to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of CRFS, source documents, medical records, and regulatory documents; provide feedback to assigned sites and information regarding detected deficiencies and corrective action needed.  Follow-up with sites on deficiencies are resolved. Perform other related duties to the work described in regards to the study guidelines.

QUINTILES INC., DURHAM, NCSr. Clinical Assistant, Clinical OperationsSeptember 2001 –December 2002 Primarily responsible for providing central support to the clinical project team through the independent and effective performance of activities. These activities included the coordination and maintenance of project documentation, clinical tracking and information retrieval. Worked independently and closely with Clinical Team Lead, CRA or Sr. CRA to accomplish project and team goals. Mentored new team members as well as other new employees with database issues, helpline problems as well as FedEx and training on an as needed basis. Responsible for IRB submission, approvals and tracking this into study spreadsheet and Intraxx database. Work with investigators, study coordinators for site related issues. Help with Investigator meeting in transportation, hotel reservations. Getting all documents for completion as well as tracking forms to get all missing documentation during the meeting. Set up sign in sheets for accurate account of all attendees.

QUINTILES INC., DURHAM, NCSpecialist 1, Drug Safety and SurveillanceJanuary 2001- September 2001

Performed one or more processes included in the execution of a functional step in the adverse and serious adverse event reporting process, such as Process Initiation, Process Completion, Distribution, or Case Review. Worked

obtain resources necessary to perform project-related work, on-the-job training, requests for information, and clients, both internal and external. Worked efficiently on Clintrace database. Created and updated entry specification for several projects.

CLINFORCE, MORRISVILLE, NC Clinical Research Coordinator (Contract Position) November 2000-January 2001

Provided scientific, administrative and in-house monitoring support for clinical trials. This includes, but is not limited to, preparing and distributing study materials such as CRFs, study manuals and monitoring manuals and preparing for investigator meetings. Also assisted initiate clinical trials at investigator sites, including managing informed consent issues, assisting with investigator recruitment and site selection visits, collecting and verifying essential regulatory documents and site personnel training. Other responsibilities will include ensuring timely and accurate shipment of clinical supplies to study sites, in-house monitoring of adverse experiences, tracking patient recruitment, dealing with patient recruitment issues and developing site recruitment tools; newsletters, auditing, managing and maintaining study files and on-site/co-monitoring activities and preparing of site visit reporting.

PPD DEVELOPMENT, MORRISVILLE, NC

Research Assistant IIJune 1999- November 2000

Provided technical support to the Director, Associate Directors, Project Managers, Research Coordinator, and administrative staff. Utilized excellent organizational and technical skills, with strong attention to detail. Worked independently, as well as part of the team. Proven ability to delegate and handle multiple tasks, with effective interaction. Assisted Project Manager with biweekly and monthly reports, revising site specific budgets on an as needed basis. Processing of trip reports, generating letters, set up and completion of master and site files. Run queries and process them, track payments in the applications and generate check requests. Oversee study closeout process and track all necessary documents in study database.

PPD DEVELOPMENT, MORRISVILLE, NCResearch AssistantNovember 1998 – June 1999

Provided administrative support to Division Administration Managers, Clinical Research Associates with review and transmittal of study documents to sites, Institutional Review Boards and Sponsors. Printing of regulatory documents, collating, sending to sites. Review of documents and work with sites to revise as needed. This included bi-weekly and monthly reports, as well as other assigned tasks.

PPD DEVELOPMENT, MORRISVILLE, NCData Entry OperatorNovember 1998 – June 1999

Entered clinical trials data from Case Report Forms (CRFs), and verification of entry, filing of case report forms as they were received, entered, and verified.

PPD DEVELOPMENT, MORRISVILLE, NCTelecommunications Recruitment OperatorNovember 1998

Responsible for the recruitment of patients and physicians for clinical research studies utilizing TCC computer and telephone resources to track calls and phone conversations. Assisted with Supervision as needed, for study work during the evenings.

EDUCATION

Study Coordinator training at Duke University Clinical Research Associate Certificate while at PPD Corning Community College Corning, N.Y.

SKILLSInform, InformantExcel, Word, Access, PowerPoint, Oracle, Office Outlook, Lotus Notes, Publisher 98, Adobe WriterMedical TerminologyIntraxx database while @ Quintiles(USD, Generic Monitoring) used at DCRI RDCEDCSAP/Savion Financial System