Project Customer Service

Phyllis Hedgepeth

Hm: 919-***-****/Cell: 919-***-****

Email: **********@*****.***

Therapeutic Experience: Neurology: Alzheimer’s disease (Phase III, IIB)

Oncology: Pancreatic (Phase I/II)

System Experience: Clinical Trial Management Systems: (Siebel Clinical CTMS), EDC: (Medidata RAVE), IVRS/IWRS/RTSM: Phase Forward, ClinPhone IVRS)

EMPLOYMENT

PRA International

Raleigh, NC

In-House CRA 2

Jan 2012 – Sept. 2012

•Preparation and review of various study related tracking systems to determine and report status of clinical trial

•Preparation of all critical trial documents (e.g., monitoring guidelines, investigator site file and draft informed consent)

•Responsible for collection of outstanding Regulatory documentation

•Performs Essential Document Collection, Review, Maintenance and Close Out activities

•Communication with investigate sites on routine matters concerning on-going trials

•Handling request for trial related information.

•Performs Study Tracking to ensure that the study files are current, accurate, and complete

•Tracks clinical trial management information in CTMS

•Manage 33 investigator sites

•Assist with resolution of investigative site/data queries

•Assist with Investigational Product accountability, subject screening/enrollment, Case Report Form retrieval, and query distribution to/retrieval from investigational sites

•Provides quality review of the informed consent template

•Reviews tracking systems for assigned projects to assure that timelines are begin met as anticipated

•Manages time and project requirements based on study contract; identifies and documents out of scope activities

•Reviews essential documents for content through all phases of study

•Review and preparation of IRB submission material

•Site Feasibility and investigator selection

•Internal and External audit responses and reconciliation

•Collect, track and review study site critical documentation used to monitor interest for enrollment or investigator sites

•Ensure compliance with protocol guidelines and requirement of regulatory agencies

•Document and track all communication (email, voice, and fax) with study personnel and client interaction in accordance with study plans.

Novella Clinical Research

Research Triangle Park, NC

Document Control Coordinator

Apr2008 – Dec 2011

•Management of Clinical Document Control files room for all Novella Clinical studies paper and electronic.

•Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.

•Data Entry of site information into TMF, Handle routine document process, Interact frequently with other functional areas.

•Utilize systems and tools for electronic paper document generation, scanning and QC.

•Interface with Project Management, Regulatory and provide guidance on document /report preparation and content.

•Provide training to function group on document content formant process and procedures.

•Ensure that documents comply with the relevant, guidelines for content and format and the content reflects information submitted and cited with each study.

•Assist in preparation of audit plans and checklist against applicable standard

•Receives, inventories, clinical documents and clinical files as well as project specific regulatory documents

•Supervision of contract / permanent employees

•Assisting QA doing Sponsor Audits and Regulator Inspectation

ICON Clinical Research

Research Triangle, NC

Project Assistant

Aug 2007 – Mar 2008

•Responsible for set up maintenance of study documentation, maintenance of applicable system(s), generation of study newsletter, tracking and ordering of study supplies, assembly and distribution of study materials, generated of weekly, monthly status report.

•Assisted with investigator meeting, preparing including mailing invitations, tracking responses and travel arrangement and assembly of meeting materials

•Attending department meeting / taking minutes

•Assist with training of new personnel

•Received and disseminate study related regulatory documents and correspondence from assigned sites; assist in screening documents completeness and compliance

•Investigated incomplete, inaccurate or missing documents to ensure accuracy and completeness of data.

•Maintained communication with sites to provide information, track documentation

•Responded to routine questions related to study protocol; document all conversation in the database.

•Audit investigator files

•Tracking / Uploading information into database

PPD

Research Triangle Park, NC

Central Study Start Up Clinical Regulatory

Dec 2006 – July 2007

•Reviewed and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording/budgets

•Developed collaborative relationships with CRAs, investigative sites and client company personnel.

•Accountable for and the review and transmission of regulatory documents

Conducted investigator file reviews

•Reviewed and retain knowledge of the protocol

•Generated, resolved issue with regulatory documents

•Provided project timelines in accordance with the Contract

•Facilitate effective communication between client company, vendors, and project team in order to anticipate, identify and resolve issues for non-clinical

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Duke University

Durham, NC

Staff Assistant School of Medicine

Oct 2004 – Nov 2006

•Maintain departmental records, including project files and vendor contracts to the Clinical Trial Quality Assurance Reviewers.

•Created, Organized and maintain files, reports and correspondences, required for reference

•Initiated a database of Study Protocols for Clinical Trials Audits review

•Assembled materials for meeting and attend meetings as needed to provide administrative support.

•Liaison with Hospital Education Department

•Instrumental in resolving routine requests from requests from research community

•Attended DUHS Institutional Review Board meetings weekly meeting related to Clinical Trials ; stay abreast of information and any changes to study protocol; preparation for the presentation of 45-70 protocols per meeting

•Coordinated scheduling and monitor projects to assure compliance to project deadlines

•Daily examination of operations and handled office task such as correspondence, minutes and file management

•Prioritized, sorted and route SOM Compliance Office mail –screen and route mail and documents

GlaxoSmithKline

Durham, NC

Regulatory Associate (Contractor)

May 2004 – Sep 2004

•Audited regulatory documents

•Updated tracking system for regulatory documents approved

•Reviewed documents for completeness and reconciling

•Managed the updated study regulatory documents

•Logged documents into the database

•Ensured IRB was approved before regulatory documents were submitted to Clinical Research Department.

•Completed, accurately and in a timely manner all documentation needed in preparation for submission to IRB.

•Tracked, disseminated, receipt and approval status essential documents

•Maintain investigator database

•Collected and tracked regulatory documents

•Maintain paper and electronic for investigator and regulatory files according to SOPs and study specific requirement.

•Prepared and disseminate status reports on regulatory documents

•Updated tracking system for regulatory documents approved

Quintiles

Research Triangle Park

Clinical Trial Assistant

Oct 2002 – Apr 2004

•Reviewed and negotiate site regulatory documents and contracts with sites and sponsor for agreement on wording and budget.

•Maintained and manage SSU data tracking entries in database.

•Review documents for completeness and accuracy

•Reviewed and provide feedback to management on site performance metrics

•Served as contract for investigative sites, designated project reports, communication and customer service.

•Resolved site issues and determine status for product shipment

•Interacted with regulatory team members, sponsors to secure authorization of contracts

•Interacted with Clinical Operations, Project Management and Site Identification on SSU projected specific status and deliverables.

•Worked with team members in preparation of IEC/IRB submissions

EDUCATION

BS, Business Administration

Shaw University

PROFESSIONAL AFFILIATIONS

• SoCRA

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