This resume summarizes Gaiva Leoniene's experience in clinical research and data management roles over the past 10 years. She has worked as a clinical documentation specialist, clinical records technician, documentation specialist, and clinical data manager for various clinical research organizations. Her experience includes managing trial master files, performing data entry and query resolution, and ensuring compliance with FDA regulations and GCP guidelines.

1. Gaiva Leoniene
217 Tulip Cir, Island Lake, IL 60042
224-622-2892
gaivaleo@gmail.com
OBJECTIVE
Obtain a position allowing the utilization and expansion of my skills in clinical research.
EDUCATION
 Master’s of Science Degree, Kaunas University of Technology
QUALIFICATIONS SUMMARY
 Working knowledge of Federal Regulations, HIPPA,GCP and ICH guidelines
 Solid understanding of medical terminology
 Proficientwith MicrosoftExcel,Outlook,Word, PowerPoint, Share Pointand various
databases
 Ability to problem solve,follow through and lead by example in order to achieve
company goals
 Strong organizational, multitasking and time management abilities and detail oriented
 Capable of learning and excelling in a difficult,unfamiliar environment
WORK EXPERIENCE
Clinical DocumentationSpecialist/Clinical Studies Specialist– QAand Compliance: Randstad
Pharma on Assignment toAbbvie
April 2014 to Present
 Supporting Auditors and ProjectManager with FDA Submission Readiness for six (6) global
studies.
 Performing Reconciliation of 1572s, FDFs & QA Audit Reports.
 Assisting auditors with TMF review, organizing and filing documents according to sponsor’s
filing structure, SOPsand Federal Regulation guidelines.
 Responsible forQC Review and Itemization of all essential documents per each TMF.
 Identifying potential gaps in preparedness for Regulatory inspection.
 Managing, reorganizing and tracking of TMF to ensure files are foraudit ready.
 Generating and Maintaining study Trackers.
 Support auditor’s team withdocumentation task as requested.
 Managing deadlines in accordancewith projectplans by prioritizing tasks.
 Ensuring compliance withGCP, SOP requirements, and industry standards.
Clinical RecordsTechnician:Randstad Pharma on Assignment to Takeda Pharmaceuticals
April 2013- March 2014
 Member of the clinicalteam responsible forconducting Phase I- IV studies according to
Federal Regulations and ICH guidelines.
 Supported clinical team by primarily tracking, organizing and filing Phase I- IV study
documents accordingto Federal Regulations and ICH guidelines.

2.  Received, reviewed and organized essential documents from the Clinical Operations,
CRAs and CROs. Ensured documents are appropriate and content of those documents is
accurate, consistent/compliant withcompany’s SPOs,regulatory requirements and
corporate policies and procedures.
 Reviewed documents according to Guidelines forFDA submissions.
 Managed and maintained TMF.Correctly indexed and cataloged all types of clinical
documents records forassigned unit, using an electronic records management system
(RMS)·
 Correctly placed physical files in designated location within central file, or as required,
and updates the information in the RMS pertaining to the physical location of the files
(using a bar-code scanning device and standard data upload procedure, or using a
manual procedure)·
 Verified the accuracy of the indexing, cataloguing, and file-locating information entered
(by self) into RMS, using standard features of the RMS together with business tools such
as MS Excel and standard procedures including auditing of the files/boxes against the
information in RMS
 Meted or exceeded work quality and productivity standards·
 Maintained confidentiality and security of clinicaldocuments; maintains confidentiality
of records-related activities.
DocumentationSpecialistandClinical DataManagement:Symphony Clinical Research
(Formally known as Clinical Resource Network) Vernon Hills IL, February 2011-August 2012
 Performed management of Trial Master File, ensuring TMFs were compliant with GSP,
ICH guidelines and Federal Regulations.
 CRF data review, preparation forentry, query processing discrepancy management.
 Developed study specific database requirements and edits checkrequirements with the
help of Clinical Research Associates (CRAs) and field monitors.
 Activated and tracked new sites, users across studies for EDCstudies.
 Assisted in CRF design/development.
 Assisted in database design and validation activities (forpaper based trials).
 Assisted in development of data verificationaudit listings and other audit activities.
 Assisted the clinical team responsible forconducting Phase I-IVstudies according to
Federal Regulations and ICH guidelines.
 Performed data management activities on both paper based and electronic data capture
(EDC)studies.
 Created and maintained data management trackers and checklists formultiple projects.
 Responsible fordata entry and management activities across multiple trials in
accordancewith FDA regulations and GCP guidelines for Phase I-IV trials.
 Ensured adequate filing and archiving of relevant data and documentation.
 Worked effectively asa team player with other departments.
Clinical ResearchAdministrative Assistant:ClinicalResource Network,Vernon Hills IL,
September 2010-February 2011
 Providedsupport to Study Management team withdata query resolution, tracking study
documentation and study supplies, and maintained study documentation files.
 Maintained trial master files.
 Managed allocation of study supplies as required.
 Developed and maintained centralized database to trackand organize vendor
documentation.
 Oversaw and participated in internal and sponsor requested audits to ensure
compliance with all Standard Operating Procedures.
 Maintained a database of clinicaltrial shipments, and ensured that there were adequate
supplies of clinical trial materials to meet project needs.
 Planned, ordered and distributed non-drug clinical trial supplies.

3.  Responsible forlogging in receivedCRFs and transferring data fromthe CRFs into the
database.
 Scanned and filed study documents, Note to Files, Data Clarification Forms and vendor
documents.
 Providedadministrative support including, but not limited to, typing documents,
creating tracking spreadsheets and faxing.
 Assisted the CRA during the preparation forthe investigator study initiation meeting.
AdministrativeAssistant: Unique Realty and Investments Management Inc., Lincolnshire, IL,
February 2006- September 2010
 Responsible forscheduling meetings forinvestors and all employees; composed and
distributed inter-departmental memorandums (emails, documentary and voice)
ensuring timely delivery and receipt of important information while at the time
maintaining confidentiality.
 Prepared and assembled media kits for marketing and public relations departments,
created documents related to sales and investments presentations.
 Established and managed all electronic and paper records.
 Responsible forreal estate services-related compliance with all local, state, and federal
regulations and related agreements.
 Created, reviewed and revised addendums and amendments to contracts.
 Ability to read legal descriptions.