Ave.
Durham, NC *****
Pamela C. Williams
Objective To obtain a career position and be given the opportunity to use my skills and to
contribute in reaching the company goals and be rewarded with advancement
and professional development.
Technical Skills Ability to handle multiple tasks in a timely manner.
Strong communication skills and customer relation skills.
Ability to answer phone with multiple lines incoming and outgoing.
Proficient in Microsoft Office (Word, Excel, Access and PowerPoint).
Medical Records filing and documents; knowledge in eTMF, Indexing,
Cdexing, CASCADE, EDC, IMPACT, CTMS, Preclares systems. Knowledge of
coding I-CD9.
Strong knowledge of Medical Terminology and coding documents.
Strong organization skills.
Keyboard 35-40 wpm.
Customer Service and interpersonal skills
Able to follow GCP/ICH and SOP/WPD guidelines.
Experience 2008-Present PPD Development Morrisville, NC
Project Assistant
Review regulatory documents for proper content in accordance with FDA,
ICH/GCPs, PPD and client company SOPs prior to submission to the Project
Manager, central IRB, Regulatory Affairs and/or the client. Perform investigator
file reviews and log outstanding issues in project related tracking tools. Liaise
with monitors and investigative sites to resolve outstanding regulatory issues
identified through ongoing regulatory review and investigator file reviews in a
timely manner. Develop and maintain assigned data points within the CTMS
database according to conventions and tools for the project, within specified
timelines. Working a variety of computer system such as EDC, eTMF,
CASCADE, IMPACT.
2007-2008 PPD Development Morrisville, NC
Records Management QC Specialist
Provided primary records management and file room QC support for multiple
studies/systems at any given time. Responsible for conducting desk audits.
Worked on special projects as assigned by Records and Regulatory Managers.
Responsible for meeting deadline with multiple competing priorities and frequent
disruption. Responsible for ensuring files room security and that all records
management tasks are completed according to PPD and/or Client SOPs/WPDs.
Worked closely with clinical administration and project team members on
assigned studies to ensure accuracy. Exhibited strong problem solving,
organizing, multi-tacking skills. Work independently while QC investigator
monthly file audits and file reviews.
2004-2008 PPD Development Morrisville, NC
Senior Document Technician
Provided primary records management and file room support for multiple studies
at any given time. Worked on special projects as assigned by Management.
Responsible for ensuring files room security and that all records management
tasks were completed according to PPD and/or Client SOPs/WPDs. Worked
closely with clinical administration and project team members on assigned
studies to ensure accuracy. Organized, sorted, filed, created, and extended files.
Trained new hires of tasks and responsibilities. Started out as Document
technician 1.
2003-2004 Glaxo Zebulon, NC
Material Handler
Handled medical products such as pills, respiratory pumps, mixing some
products
to assemble and packages for shipping and sales. Worked bottling pills and
adding IB’s according to sharp aids. Work productions for various tasks
and machinery.
2002-2003 Smart Document Solutions Raleigh, NC
Information Release Representative
Reported to various clinics’ daily, scanning medical records to clinics,
doctors,
and lawyer’s offices as requested. Also checking documents for proper
authorizations.
Completed proper billing for persons requesting information. Handled other
office duties.
2001-2002 Northwestern Mutual Insurance Inc. Raleigh, NC
Office Assistant
Handled various tasks, such as answering multiple phone lines. Setting
up appointments for clients, filing, collating records and clerical duties.
2000-2001 IBM/Manpower-Electronic Kitty Raleigh, NC
Assembler
Assembled and scanned electronic parts into IBM computers. Entering
proper data
to pack and ship computers to distributors.
1997-2000 Homemaker –childcare Raleigh, NC
Maintaining duties in the home. Taking care of underage school children.
1989-1997 Duke Hospital Durham, NC
Medical Records Clerk II
Handled discharged patients’ medical records, making sure all medical
documents
and forms are filled out and signed by doctors. Entering data into database
terminal
to channeled charts to completion area and other office duties.
Education 1987 Durham Technical Community College Durham NC
Completed 330 hours Certificate program.
Relevant courses: Medical insurance claims examiner, clerical/office support.
References upon request