Drug Safety Associate (familiar with Medra and WHOdrug dictionary

LISA WATERS, RN

**** **** ****** ******, ************, Pa 215-***-**** **************@*****.***

SUMMARY

Organized, timely and detailed oriented with a diverse background in the pharmaceutical field for twelve years as a Drug Safety Associate, Clinical Data Coordinator and Manual Encoder. Experience includes Phase I thru Phase IV studies in a variety of therapeutic areas. Seeking for the following positions: Clinical Research, Quality Assurance, Regulatory, Compliance/Safety and Coding Specialist. Knowledge of GCP/ICH guidelines and FDA regulations. Excellent communication skills.

THERAPEUTIC EXPERTISE

Oncology: Human Papillomavirus Vaccine, Prostate Cancer Prevention, Acute Myeloid Leukemia, Metastasis Breast Cancer, Non-Hodgkin Lymphoma, Lung Cancer, Head and Neck Cancer

CNS: Neurology - Alzheimer, Migraine, Attention Deficit Disorder, Attention Deficit Hyperactive Disorder

Pain: Analgesia

Infectious Disease: HIV and associated opportunistic infections

Cardiovascular: Hypertension, CHF

GastroIntestinal: Acid Reflux, Gastric Esophageal Reflux

Allergy/Immunology: Pediatric Vaccine

AntiFungal: Tenia Pedis

Hematology: Anemia

Women’s Health: Oral Contraception

Endocrinology: Diabetes Mellitus

PROFESSIONAL EXPERIENCE

Icon Clinical Research Organization, Northwhales PA December 2010 - May 2011

Drug Safety Associate (contractor)

•Processed clinical trial serious adverse events using Argus version 5.0

•Wrote descriptive narratives

•Coded adverse events utilizing Medra version 14.1

•Coded medications utilizing the WHOdrug dictionary

•Ensure follow-up information is processed accurately

•Wrote, issued and resolved queries

•Communicated with site and sponsors via fax, telephone or e-mail

•Attended project team meetings and teleconferences

Johnson & Johnson Pharmaceutical, Malvern PA July 2010-August 2010

Drug Safety Associate II(contractor)

•Reviewed patient medical records, patient profiles and legal documents in various studies

•Identified and extracted all information pertaining to patient serious adverse events

Alliance Healthcare Information, Ivyland, PA March 2010-May 2010

Healthcare Information Specialist (contractor)

•Utilized the DBASE Argus to process serious and non-serious post marketing reports

•Wrote descriptive narratives

•Coded adverse events utilizing Medra version 12.1

•Coded medications utilizing the WHOdrug dictionary

•Ensured follow-up information was processed accurately

Merck & Company, Inc., Blue Bell, PA January 2008-July 2008

Manual Encoder (Contractor)

•Encoded medical history, lab results and adverse events using Medra version 11.0.

•Encoded Medications utilizing WHOdrug dictionary

•Wrote, issued and resolved manual queries using Inform EDC systems.

•Trained and supervised 10-15 individuals to encode using Medra version 11.0.

•Communicated discrepancies and inconsistencies to appropriate team members.

•Generated and updated reports.

Merck & Company, Inc., Blue Bell, PA January 2007-July 2007

Manual Encoder (Contractor)

•Encoded medical history, lab results and adverse events using Medra version 10.0.

•Encoded medications utilizing WHOdrug dictionary

•Wrote, issued and resolved manual queries using Inform EDC systems.

•Communicated discrepancies and inconsistencies to appropriate team members.

•Generated and updated reports.

CRI Worldwide, Philadelphia, PA October 2007- December 2007

Nurse Study Coordinator

•Organized and conducted clinical trials for Phase I Studies.

•Ensured Compliance with protocol, GCP guidelines, and FDA regulations.

•Prepared all documents for periodic monitoring visit.

•Conducted consent discussions, and obtained informed consents.

•Receipt of investigational product, dosing, and administration and accountability.

•Completed or ensured completion of source documents.

•Performed quality assurance on case report forms and source documents.

•Reviewed regulatory documents for accuracy and completion in preparation for IRB.

ES Incorporated, King of Prussia, PA March 2006 - September 2007

Appeals Officer (Contractor)

•Wrote reconsideration determinations on Medicare appeals.

•Reviewed cases for issue assessment, factual determination and summary.

•Correctly matched denied items(s) and argument(s) to Medicare Policies.

•Identified case requirements and issues for review by independent physician consultants.

•Researched issues and renders decisions based on pertinent facts of each case.

•Issued “The Determination” in a concise report to all appropriate parties as required by the specific client contract.

•Researched issues covered by federal, state and “Center of Medicare Services” policies via Internet and hard copy tools.

American College of Radiology, Philadelphia, PA June 2005 - September 2005

Research Associate (Contractor)

•Reviewed protocol guidelines for diagnostic imaging clinical trials.

•Wrote, issued and resolved queries.

•Performed quality assurance of medical records and case report forms.

•Reviewed medical data for diagnostic images according to protocol guidelines.

•Communicated discrepancies with monitors and coordinators.

McNeil Pharmaceutical, Ft. Washington, PA June 2004 – September 2004

Drug Information Associate (Contractor)

•Used Sceptra DBASE to process non-serious post marketing reports.

•Ensured expedited cases with FDA requirements were processed immediately.

•Coded adverse events, medical history and diagnosis via Medra.

•Wrote descriptive narratives.

•Determined expectedness concerning adverse events according to FDA regulations.

•Ensured that follow-up information was processed accurately.

Hobart West Solutions, Philadelphia, PA August 2003 - May 2004

Auditor (Contractor)

•Verified credentials of providers.

•Reviewed medical records according to guidelines.

•Performed quality assurance reports and medical records.

Communicated with providers via telephone or fax.

AstraZeneca Pharmaceutical, Wilmington, DE January 2003 - July 2003

Clinical Data Coordinator (Contractor)

•Communicated discrepancies with monitors and site coordinators.

•Utilized protocol for Phase III Central Nervous System Study.

•Reviewed case report forms using electronic data capture system.

•Used Phase Forward Online System to write, resolve, and issue queries.

•Performed validation and database locking.

•Read protocol and reviewed case report forms according to protocol guidelines.

•Generated and updated reports.

Janssen Pharmaceutical, Spring House, PA April 2001-February 2002

Drug Safety Associate (Contractor)

•Processed adverse event reports for Post Marketing and Investigational New Drugs.

•Ensured that expedited case s with FDA requirements were processed appropriately.

•Coded serious and non-serious adverse event using WHOdrug Dictionary.

•Wrote descriptive narratives and entered medical diagnosis using ICD-9 coding.

•Ensured that case reports and “follow-up” data were entered accurately.

•Made expectedness decisions concerning core safety information and US labeling.

SmithKline Beecham, Philadelphia, PA January 1999-April 2001

Clinical Data Coordinator (Contractor)

•Performed data entry of case report forms (CRF).

•Generated, updated and distributed reports.

•Read and set-up protocols in Phase I Management Systems (PIMS).

•Performed Quality Assurance of medical records, case report forms and software.

•Tested and validated software.

EDUCATION

Diploma in Nursing, Frankford Hospital School of Nursing, Philadelphia, PA 1996

Bachelor of Science in Biology, Indiana University of Pennsylvania, Indiana, PA 1988

Continuing Education Courses, Philadelphia, PA.2008 to present

LICENSURE:

Certification Number: RN-523405L, August 20, 1998

COMPUTER SKILLS:

Operating Systems: MS Windows XP, Windows 95, Windows NT

Software: Lotus Notes 6.5, MS Word 2003, MS Excel 2003, WordPerfect 5.1, Clinical Trial System, BBN/Clintrial 3.3, MS Access 2.0, Word 97, Access 97, Excel 97, Phase I Management System, ARISg, Phase Forward System, Microsoft Outlook, ACRIN Web Sourcing, Medicare Appeals System, HPMS, CTS (clinical trial system) - Oracle Database 8.6, CDE (clinical data entry) 8.5, Inform 4.5, Central Coding for EDC 1.0, Argus 2.1, Medra 12.1 and WHOdrug dictionary

TRAINING:

GCP Training, EDC Inform Training, EDMS, ICD-9, Medra 10.0, 11.0,12.1, 14.1 and CTMS

Contact this candidate