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Seasoned clinical data management specialist with a proven track record of exceeding job objectives.
Stellar listening, verbal communication and interpersonal skills to gain the trust of key stakeholders.
Proactively identified and resolved problems in real time in order to implement favorable solutions.
Outstanding time management, attention to detail and organizational skills to juggle multiple priorities.
Baltimore Research Education Foundation Jan. 2007-Present
Performed with the Perry Point & Baltimore VA Healthcare System in their Research and Development Department under the Cooperative Studies Program as a Clinical Data Manager over the past 9 years.
Data Management Specialist, VA Healthcare System (Oct. 2014-Present)
Communicate effectively with the Nurse Research Associate, Program Coordinator, Research Associate and Clinical Research Statistician to achieve research goals.
Manage data, creating databases in IBM SPSS and resolving any problems in a timely manner.
Serve as Content Manager for a Microsoft SharePoint 2007 Depleted Uranium Study.
Train personnel, including a Data Specialist, on the DataFax data capture and cleaning programs by developing presentations and maintaining communication.
Write custom code for editing programs and edit check development.
Used SAS statistical programming system to run reports using output files from DataFax.
Create clinical research forms in SPSS and Microsoft InfoPath.
Clinical Data Associate, National Institute on Drug Abuse (Dec. 2012-Sept. 2014)
Trained study site personnel on accurate completion of case report forms, data collection, data review, and resolving data discrepancies, including leading presentations.
Conducted junior level programming edits and other quality control and assurance checks to ensure data integrity and consistency.
Performed basic CRF forms design for EDC (Medidata) and for DataFax, Micrsoft Word and Adobe PDF.
Created variables in a UNIX system.
Helped secure and maintain ISO 9001:2008 Certification from the Department of VA Research.
Ensured clinical trial compliance to adhere to FDA, GCP and ICH guidelines.
Clinical Data Associate, University of Maryland School of Medicine (Jan. 2007-Dec. 2012)
Served as a key liaison between the site and sponsor.
Acted as Lead Assistant for an International Study Team.
Played an integral role with database design using C (UNIX) and reviewing and updating SOPs.
Performed data entry using the DataFax application.
Bechtel Corp. Nov. 2002-Nov. 2005
Administrative Lead Assistant (May 2005-Nov. 2005)
Prepared reports for presentations pertaining to time record audits and also analyzed time and attendance records for discrepancies.
Instruct and verified that individuals followed security requirements.
Issued security site access badges and PPE for new hires and visitors
Operations Coordinator (Nov. 2002-May 2005)
Trained new hires on the Info Works System and trades of the job.
Led audits for major engineering and control system documentation.
Validate and review working copies of SOPs.
PC Maintenance Degree, Penn Foster College; currently pursuing
Coursework: Network Protocols; Desktop Support and Installation of Hardware; Troubleshooting Windows Operating Systems; Programming in CGI/Perl; and Advanced Database Technology 0 Oracle & SQL.
Career Diploma in General Science
Career Diploma in Human Anatomy and Physiology
Studied Microsoft Office 97 & 2000 and Microsoft Office (Word, Excel, PowerPoint) and Access, as well as
Boolean Algebra, PC Repair, Networking and Programming in Java 6, York Technical Institute, 2000 - 2001
Completed training of Medidata electronic data capture system
Six Sigma White Belt Certified
C# Beginner Certified
Windows 7 and Microsoft Office 2007 Suite Certified
Authored a publication on the use of Microsoft Groove as a data transmission platform for an international study, which partnered with the VA, University of Maryland and Gates Foundation:
Crayton. C and Kousick B. Using Microsoft Groove as a Data Transmission Platform in a Large Scale Epidemiological Study with Asian and African Sites, Society Clinical Trials 31st Annual Conference. Baltimore Marriott Waterfront. Baltimore, MD Cooperative Studies Program Coordinating Center. Perry Point, MD, May 2010.
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