About The Position

The Clinical Research Data Specialist I handles the data for assigned research studies. This will include, clinical data abstraction, processing data, maintaining record systems, and producing project reports for studies. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

Responsibilities

  • Manages and maintains research data to ensure accuracy, integrity, and security of complex, large computerized records systems. This includes performing data searches and other related administrative tasks.
  • Processes clinical data using a range of computer applications and database systems to support cleaning and management of subject or patient data.
  • Designs forms for data collection and performs clinical data collection/abstraction.
  • Produces project reports for research studies.
  • Understands regulations, policies, protocols and procedures to control and maintain accurate records.
  • Maintains research practices using Good Clinical Practice (GCP) guidelines.
  • Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
  • Participates in required training and education programs.

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What This Job Offers

Job Type

Full-time

Career Level

Entry Level

Education Level

No Education Listed

Number of Employees

5,001-10,000 employees

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