Clinical Research Coordinator I

 

Summary


 

 Clinical Research Coordinator works closely with study leadership to satisfy applicable internal and external clinical and regulatory requirements for assigned clinical studies. Focuses on tasks related to site document management and data collection. Works under direct supervision. Develops alternatives and solutions for problems of limited scope and complexity.

Document and data management

  • Creates and manages study files and regulatory binders
  • Tracks and distributes clinical study documents including: documentation, agreements, site approvals, IRB’s, EC’s, data compensation, etc.
  • Interacts with site staff for data collection and follow-up
  • Completes data entry
  • Reviews study documents including completed case report forms DCFs, draft CRFs and edit checks to ensure practicality of data entry
  • Problem/troubleshoot
  • Proposes solutions, proof reads, and makes formatting suggestions
  • Identifies issues related to site readiness documents
  • Assists with periodic internal file reviews of clinical study files for completeness
  • Assists study team with critical study document finalization, such as contract amendments, informed consent revisions, etc.Reporting and review
  • Assists in compiling reports as requested
  • Actively participates in user acceptance testing of study databases based on protocol requirements
  • Creates accurate and consistent reports for assigned centers as requested, following established practices for the study (DCFs, compliance reports, etc.)
  • Assists with clinical report development (interim, final, regulatory, committee, etc.)
  • Assists with monitoring tasks, such as regulatory file reviews and preparation, as appropriate for the assigned studyGeneral administration
  • Assists with meeting planning and preparation for investigator and committee meetings
  • Prepares and distributes team meeting minutes following each team meeting
  • Assists with training of new clinical team members
  • May contribute to ongoing project-specific process improvement efforts
  • May contribute to ongoing departmental process improvement efforts
  • Assists study team members with performing study closure activities
  • May provide input into study budget and schedule
  • Performs other related duties as assignedQualifications:
  • High school diploma required
  • Experience performing data entry with near perfect accuracy
  • Aptitude for clinical research or coursework in science or clinical research
  • Ability to meet deadlines
  • Plans and organizes own work to meet project demands but seeks assistance to prioritize work when needed
  • Clearly communicates ideas in verbal and written formats
  • Proficiency with Microsoft OfficePreferred Qualifications:
  • Prefer an Associate’s degree
  • Prefer 1+ years of experience within clinical research

 

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