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
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Professional Experience
Northside HospitalRoswell , GAResearch 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.
Massachusetts General HospitalHolyoke , MASystem 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.
Cyberonics, IncCity , 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 ofBiostatistician, 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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