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Research Data Specialist Resume Example

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RESEARCH DATA SPECIALIST
Professional Summary

A highly resourceful, flexible, innovative, and enthusiastic individual who possesses a considerable amount of knowledge in clinical research. A quick learner who can absorb new ideas and is experienced in coordinating, planning and organizing a wide range of activities.

Skill Highlights
  • Experience in variety of clinical settings
  • Knowledgeable in Medical Terminology
  • Patient Screen
  • Consenting
  • Computer literate
  • Proficient in MS Access, Word, Excel, and PowerPoint
  • Oracle IB
  • Smart Form
  • Visio
  • Qualtric Software
  • Clinic Station
  • CORe
  • SharePoint
  • Prometheus
  • GURU
Professional Experience
Company NameCity, StateResearch Data Specialist03/2010 to Current
  • Maintain work knowledge of Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines and HIPAA.
  • Collaboration with the Principal Investigator (PI) and Research Nurses on Active Surveillance Study (early prostate cancer).
  • Assesses patients for eligibility through personal interviews; medical records review; provide educational needs regarding schedule protocol appointments; and procedures.
  • Meet with patients and responsible for ensuring the consent is understood, signed and processed appropriately.
  • Responsible for accurate and timely transcription of study data into ClinicStation.
  • Responsible for completing CSRs, tracking return visit time points per protocol.
  • Responsible for tracking and recording deviations, violations, adverse events and other study related activities.
  • Responsibilities include working independently and proactively to review source documentations and case report forms for completeness, accuracy, and consistency, and resolving data discrepancies for single-institution and/or multi-center projects.
  • Supports the regulatory team in the maintenance of regulatory documents.
  • Assists with preparation for inspections, audits, and interim monitoring visits.
  • Partake in the P&P Committee regarding departmental process and procedures.
  • Assist with other protocols as needed.
Company NameCity, StateSystem Analyst (Contract Worker)07/2007 to 07/2008
  • Defines application (Forms Anywhere) problem by conferring with other Analysts and internal clients; evaluating procedures and processes.
  • Lead project planning, project definition and requirements definition with internal clients.
  • Develops solution by preparing and evaluating alternative workflow solutions.
  • Investigate data discrepancies.
  • Assisting in the development of, and migration to, new platforms.
  • Detects and resolve application errors.
  • Assist with troubleshooting and password resets.
Company NameCity, StateClinical Data Manager08/2001 to 01/2007
  • Primary responsibilities included: Setting up databases, generating reports of clinical trials.
  • CDM processes data using a range of computer applications and database systems to support collection, cleaning and management of patient data.
  • Ensured complete, accurate and consistent data for reporting to Study Directors, Director of Biostatistician, Clinical Scientists, and Clinical Sites as needed to ensure completeness and quality of all clinical data.
  • Facilitated in the development of clinical study protocols and other study-related documents.
  • Analyzed and presented data to sales staff and physicians.
  • Trained employees on new database systems and procedures.
  • Other duties included: answering and directing phone calls, customer service, filing records, prepared memos, correspondence, reports, spreadsheets, and other documents.
  • Perform extensive internal and external quality control checks on the data on a regular basis and formal documentation of any issues.
  • Supported office staff with special project and other administrative duties as needed.
Education and Training
Bachelor of Science:Health Information ManagementUniversity of Phoenix

Health Information Management

Associate of Applied Science:Health Information ManagementSan Jacinto College (SE), City, State

Health Information Management

Additional Information
  • Nominated for the Julie and Ben Rogers Award for Excellence - August 14, 2012
  • Awarded for MD Anderson Cancer Center Division of Cancer Medicine - Citation for Excellence Clinical Research - May 23, 2012
  • Awarded for Depression PMA Submission for the FDA - 2003
Skills
  • Experience with research protocols and regulatory, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
  • Proficiency in Microsoft Office applications and database applications, which includes clinical research databases.
  • A self-starter with ability to manage multiple priorities.
  • Strong Interpersonal skills.
  • Attentive to details.
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Resume Overview

School Attended

  • University of Phoenix
  • San Jacinto College (SE)

Job Titles Held:

  • Research Data Specialist
  • System Analyst (Contract Worker)
  • Clinical Data Manager

Degrees

  • Bachelor of Science : Health Information Management
    Associate of Applied Science : Health Information Management

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