PENNY WILLIAMS

**** ****** ******, ************, ** 19104

H 215-***-**** C 215-***-****

dtsyce@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

•Over 16 years experience in the healthcare industry as a Regulatory Associate, Clinical Trial Project Assistant and Medical Records Administrative Assistant.

•Therapeutic areas include Oncology Phase I-IV studies

•Trial master file set up and maintaining project and investigator files, shipping supplies and documents to investigator sites, preparing regulatory binders, screening and handling phone calls, scheduling and coordinating meetings, and acting as a liaison for the hospital and departmental vendors.

•Medical terminology, study procedures, including FDA rules, GCPs (good clinical practices), US and international phase I–V studies, especially oncology, ICH

Guidelines, CARF, JCAHO, and government quality standards, investigational new drug (IND), SOPs, new drug application (NDA), sponsor study report (SSR), informed consent form (ICF), institutional review board (IRB), adverse and serious adverse event reports,

statement of investigator (FDA form 1572), case report form tracking, investigator agreement, monitoring and compliance audit, site visit, clinical laboratory supplies

•Pursing BS in Computer Information Systems/Health Information Management

•Proficient with Microsoft Word, Excel, PowerPoint, and Outlook

•Hard-working, dedicated team player with excellent communication skills

PROFESSIONAL EXPERIENCE

MedFocus at GlaxoSmithKline

3/08-5/09

Trial Master File (Regulatory Associate) Consultant

•Responsible for day to day organization of the central regulatory file room.

•Maintain both paper and EDC trial master files.

•Provide prompt customer service to all internal regulatory file requests

•Coordinates documentation, performs quality checks in accordance with federal guidelines and SOP’s

•Trial Master file set up in both paper and electronic copy per client SOP's and maintain accurate records.

•Perform record entry, document tracking, scanning and filing on a day-to-day basis.

•Act as a liaison between study teams and regulatory groups during audits

•Ability to work effectively within interdisciplinary teams

•Ability to effectively handle competing priorities

•Computer proficiency in a variety of databases and software applications

•Knowledge of study processes and procedures, including FDA regulations

•Familiarity with SSR,ICF’s, Clinical Labs/Supplies, IRB’s, 1572’s, Investigator Agreements, monitoring/contacts, relevant correspondence, CARDS(Correspondence Regulatory Document System), PIER(electronic repository), HAZclass(hazardous training), Elearning(Electronic Learning System)

•Performs daily updates to audit checklist and study startup

•Therapeutic areas include Oncology for Phase I-IV studies.

Numoda Corporation

11/07-1/08

Clinical Trial Project Assistant

•Coordinates documentation, performs quality checks in accordance with federal guidelines and SOP’s

•Monitoring data for accuracy and completeness, communicate progress and issues to project team in a timely manner

•Set up and maintain project and investigator files

•Schedule and coordinate meetings for internal and external personnel

•Fax, photocopy, and distribute study related documents

•Provide clerical and administrative support to project teams

•Contact study personnel at sites regarding administrative issues

•Ship/mail supplies and documents to clients, investigator sites, and IRBs as needed

•Generate and maintain study-specific tracking spreadsheets

•Assist in assembling materials and binders for investigators meetings

•Prepare regulatory binders (Study File Notebooks) for study sites

•Maintain Investigator payment documentation

Magee Rehabilitation Hospital

7/96-11/07

Medical Records Administrative Assistant

•Coordinated documentation, performs quality checks in accordance with federal guidelines and SOP’s

•Distributed reports through Local Area Network(LAN) and mail

•Monitored data for accuracy and completeness, communicate progress and issues to project team in a timely manner

•Maintained confidentiality with respect to patient medical records and hospital information

•Scheduled and coordinated meetings for internal and external personnel

•Installation of Optical Imaging process, and quality monitoring of scanned document

•Trainer and education of medical staff and hospital personnel on use of Optical Imaging Technology

•Provided assistance to support other team members as needed

Magee Rehabilitation Hospital

9/91-7/96

Medical Records Clerk

•Prepared records for scheduled visits with physicians and clinical staff

•Analysis of records for compliance with federal/state regulations and CARF/JCAHO standards relating to documentation

•Supporting and meeting the needs of and outpatient clinical staff

•Create pending and permanent record folders

•Answering calls and inquiries regarding release of information

•Performing other related duties and special projects as required by supervisor

EDUCATION

DeVry University Business Administration

Anticipated Graduation Date: 12/2011

Community College of Philadelphia

Philadelphia, PA 2007

University City High School, Philadelphia, PA

High School Diploma

Computeach Computer School

Certification in MCSE, 1997- 1998

Magee Rehabilitation Hospital

Optical Disk Training, 1996

Customer Service Training 1997, 2001, 2003

SKILLS

•Microsoft 2003 Server, Microsoft Word, Excel, PowerPoint, Lotus notes, Groupwise, Outlook, C.P.S.I., SMS System, Softmed

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