About The Position

Under general direction, this position is responsible for providing basic to intermediate analysis and documentation of business and management problems for systems and programming requirements. Assist in providing solutions to problems utilizing more efficient operational procedures, workflows, and information technology solutions. Within ITS-Research Information Systems, this position serves as the primary technical administrator for the institution's clinical trial management system (CTMS) portfolio: OnCore and eReg. The analyst partners daily with the Office of Clinical Research, study coordinators, and research administration to configure protocols, manage user access, maintain regulatory binder structures, resolve system issues, and act as the day-to-day liaison to the software vendor. The role sits at the intersection of research operations and information technology, and it supports systems that carry regulated study documentation subject to institutional, sponsor, and federal oversight.

Requirements

  • Bachelor’s degree equivalent and one (1) year of related experience
  • Ability to write SQL queries or build reports for data extraction and operational reporting

Nice To Haves

  • Bachelor's degree in computer science, health informatics, information systems, or a related field
  • Hands-on experience administering or supporting a clinical trial management system, electronic regulatory binder platform, electronic data capture system, or comparable research application
  • Working knowledge of clinical research operations, including protocol lifecycle, subject enrollment, IRB submission and approval workflows, and study documentation requirements
  • Familiarity with regulatory frameworks governing clinical research systems, including 21 CFR Part 11 electronic records and signatures, Good Clinical Practice, and HIPAA

Responsibilities

  • Configure protocols
  • Manage user access
  • Maintain regulatory binder structures
  • Resolve system issues
  • Act as the day-to-day liaison to the software vendor
  • Provide basic to intermediate analysis and documentation of business and management problems for systems and programming requirements
  • Assist in providing solutions to problems utilizing more efficient operational procedures, workflows, and information technology solutions

Benefits

  • Actual salary commensurate with experience
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