Sign in

Medical Staff Nurse

West Chester, Pennsylvania, United States
October 31, 2016

Contact this candidate



*** ******* ****

West Chester, PA 19382



Summary Many years of diverse nursing knowledge acquired from within the hospital and corporate environment. Demonstrated strengths in organizing, problem solving and communication…Computer skills including Word, Word Perfect, Lotus, Outlook, Excel and Power-Point.

Training and working knowledge of WHOart, WHO Drug Dictionary, MedDRA, Clintrace and ARISg databases.

Education Excelsior College, Albany, NY

B.S. in Liberal Arts

Delaware County Community College, Media, PA

A.S.N. in Nursing

Licensure/ Professional Nurse, Pennsylvania, RN

Certification Chemotherapy certification

Gerontology certification

Pain management certification

TPN, Central Line and Intravenous certification

Basic Cardiac Life Support


04/2007 – 05/31/2016 Bio Clinica

Medical Dictionary Coding Specialist

Performed sponsor-specific quality review of medical coding for up to 40 concurrent global studies.

Developed introductory medical coding training program and conducted group presentations locally and via teleconferences to ensure continuity in coding practices across multiple sites. Performed clinical data review for various studies to assure accuracy and completeness. Issues data queries as needed and reviews and accepts answered queries.

07/2006 – 04/2007 MedTrials, Inc.

Clinical Reviewer

Reviewed Case Report Forms (CRF’s) to ensure accuracy in the daily coding of adverse events, medical history and con medications; generated queries and performed follow-up as needed. Executed final QC audits on CRF’s to ensure compliance with protocol.

02/2006 – 07/2006 Cephalon, Inc.

Technical Associate/Global Product Safety

Maintained files, entered safety data into the ARISg safety database and forwarded Serious Adverse Event (SAE) reports to clinical project teams. Submitted International Alerts to Regulatory Affairs, affiliates, and business partners. Performed ad hoc searches in the Clintrace safety database and prepared findings for

team meetings.

Karen O. Battista, BS, RN Page 2

04/2004- 02/2006 McLaughlin Associates

Clinical Study Manager

Set up and managed multiple concurrent studies for Glaxo SmithKline, involving quality review of regulatory, licensing, and financial documents for new Principal Investigator participants. Validated and tracked study documentation, including IRB approvals and amendments; issued queries, and coordinated the collection, audit, and submission of regulatory data. Managed SAE resolutions between sites and Glaxo SmithKline’s Drug Safety Department. Executed on-site quality control audits of on-going studies.

12/2002 – 04/2003 Adolor

Medical Dictionary Coding Specialist

Performed coding of adverse events, medical history along with prior and concomitant medications for clinical trials and post-marketed products.

04/2001 - 08/2008 AstraZeneca

Safety Data Analyst

Processed incoming CRF’s, identified protocol violations and errors of omission, and performed tracking of in-house and outstanding CRF’s using tracking spreadsheets.

10/1997 – 08/2000 Wyeth Pharmaceuticals, Inc.

Medical Dictionary Coding Specialist

Identified and resolved auto-encoding failures for medications and adverse events.

Researched foreign and domestic references to create new codes for single ingredient medications and compounds following the Anatomical Therapeutic Chemical (ATC) classification system.

10/1993 – 10/1997 Briton Manor

Infection Control Nurse and Staff Development Coordinator

Verified employment references/licenses and provided orientation and mandatory in-service training for all employees. Conducted infection control audits and administered annual vaccinations to residents and staff. Coordinated preparation and execution of JCAHO survey, earning full accreditation with no recommendations for assigned departments. Functioned as Assistant Director of Nursing, House Supervisor, and Charge Nurse during tenure. Completed a JCAHO survey, with over six months of intensive training and preparation, with accreditation on April 23, 1997. Received no recommendations.

07/1992 – 02/1993 Chester County Hospital

Clinical Staff Nurse

Oncology Unit

Medical Surgical Unit

02/1987- 07/1992 Mercy Catholic Medical Center

Clinical Staff Nurse

Oncology Unit

Medical Surgical Unit

Intravenous Therapy Team

Contact this candidate