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.
  • Manages and maintains clinical and Biobank research data for IBD Institute studies, including data abstraction, cleaning, validation, and secure record management in compliance with GCP, HIPAA, FDA, and IRB requirements.
  • Designs and implements data-collection tools and study forms, and support accurate integration of clinical, bio-specimen, and outcomes data into the MIRIAD dataset.
  • Develops, maintains, and uses interactive dashboards and routine reports (e.g., Tableau, Google Data Studio) to visualize MIRIAD Biobank metrics, research impact, and patient engagement for internal teams, donors, and public-facing materials.
  • Supports the IBD Institute’s digital transformation and sustainable outreach initiatives by employing curated datasets to assist with digital recruitment campaigns, improve patient enrollment, and strengthen donor engagement and institutional visibility in precision IBD research.
  • Performs data queries, audits, and administrative reporting tasks to ensure data integrity, regulatory readiness, and timely delivery of study and departmental reports.
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