Karen Winton, BA, CCRP

**** ******** ***, *******, ** 38107

Home/cell: 901-***-****

Email home: uugqgr@r.postjobfree.com

TECHNICAL SKILLS

Cerner, Hyperion BRIO, Microsoft Access database design

PROFESSIONAL CERTIFICATION

SoCRA - Certified Clinical Research Professional (CCRP) from May 2000, current through May 2012

EXPERIENCE

09/27/04 to 07/14/11

St. Jude Children's Research Hospital (SJCRH), Memphis, Tennessee – Clinical Research Associate II

Primary responsibilities: Interface with study team members to facilitate clinical trial management

• Assist study teams with delineation of protocol sets to enhance study analysis

• Facilitate operational aspects of study initiation

• Maintain regulatory binder

• Prepare regulatory documentation

• Prepare study budgets for submission to the clinical trials budget and billing office

• Prepare regulatory documentation and submissions through the electronic IRB system (TRACKS)

• Design case report forms (CRF)

• Work with Business Analysts to translate clinical protocol data requirements to database design

• Test database prior to production

• Design desktop Access database to track protocol required observations

• Abstract study data from patient electronic medical record and paper charts

• Design and abstract data through Hyperion BRIO queries for presentation at study team meetings

• Perform ad hoc data quality checks

• Prepare data dictionary

• Prepare study desk manual

• Facilitate monitoring visits with internal and sponsored studies

• Perform quality audits to ensure compliance with institutional grant and clinical protocol objectives.

• Assist Director of Clinical Trials Management in SOP development.

• Mentor clinical fellows and CRA peers in CRIS and BRIO data entry and retrieval for their studies

• Make recommendations to clinicians for new work processes in documenting medical histories.

8/3/98 to 9/10/2004

ETSU Cancer Center/St. Jude Tri-Cities Affiliate, Johnson City, Tennessee - Clinical Research Coordinator.

Primary Responsibilities:

• Data management and regulatory compliance for NCI supported cooperative projects in pediatric cancer for the Children’s Oncology Group (COG) and St. Jude Children’s Research Hospital, Memphis, TN, pediatric cancer clinical trials.

• Patient registration, data abstraction, remote data entry

• Facilitate distribution of blood and tissue sample mailings with hospital pathology for submission to reference labs and tissue repositories

• Interface with radiology, radiation oncology, surgery and pharmacy to coordinate clinical research protocol requirements

• Access database design to manage study timelines

• Maintain regulatory binder

• Prepare regulatory documents: protocol, consent forms

• Coordinate contract (LOA’s, Clinical Study Agreements) negotiations between the project sponsors and academic institution through account set-up.

• Mentor patient enrollment information for yearly regulatory submissions.

• Work with physicians outside pediatric oncology and their nursing staff to facilitate regulatory submissions of pharmaceutical company sponsored clinical research studies

9-94 to 8-98

East Tennessee State University (ETSU), Johnson City, Tennessee

IRB Secretary for the Institutional Review Board (IRB) - Office of Sponsored Programs Administration:

Primary Responsibilities:

• Coordinate all activities of the ETSU/Veteran’s Administration Institutional Review Board (IRB).

• Recorded meeting minutes and facilitate committee action.

• Mentor graduate students on IRB submissions.

• Act as liaison among investigators, committee, and outside agencies (OPRR and FDA).

• Maintain confidential files, composition of all correspondence, including correspondence for the university president’s signature in support of matters between the university and the Office for the Protection of Research Risks.

• Design Access database to track all IRB activities.

• Administrative coordination of the Research Development Committee, Radiation Safety, and IACUC Committees. Assisted the VP for Research in conducting Scientific Misconduct inquiries. Supervision of graduate assistants and student worker clerical support.

EDUCATION

University of Tennessee Health Sciences Center, Memphis, TN – Coursework in Master’s Program in Health Informatics and Information Management.

George Washington University, Washington, D.C. – Coursework in the Masters of Health Sciences Program, Clinical Research Administration track.

East Tennessee State University, Johnson City, Tennessee, Bachelor of Arts degree 1998

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