Report Coordinator Specialist

4 weeks ago

Olathe, United States Integris BioServices, LLC dba KCAS Bioanalytical and Biomarker Services Full time

When you work as the Report Coordinator Specialist at KCAS Bio, you are an essential part of a technical writing team and assist in accurately reporting pre-clinical and clinical bioanalytical data and become part of implementing or developing new processes that helps reduce the data to report timelines.  

Our Pharma Discovery lab team uses their expertise to perform fast turnaround on client ideas at the earliest stages of the research process, including testing new drug molecular structures or delivery mechanisms. 

Learn more about our work in Pharma Discovery here: Discovery & Early Development Services - KCAS Bio
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In this role, we will rely on you to:

  • Extract information from protocol and study data to generate the materials and methods sections of study reports
  • Create data tables for reports from automated data collection systems or manual data if applicable
  • Ensure that tables are an accurate representation of data as indicated by the protocol and amendments
  • Review contributing scientists' sub-reports for completeness and adherence to regulatory compliance requirements
  • Import data tables and contributing scientists' sub-reports using appropriate technical tools
  • Create and update electronic report files to maintain document control
  • Create file-searchable PDF version of the report deliverable and incorporate scientific sub-reports in accordance with FDA guidelines
  • Prepare documents for submission to the Quality Assurance Unit; resolve audit findings and facilitate the responses of report issues with other departments for QA resolution
  • Participate in study-specific pre-initiation meetings; anticipate reporting issues and suggest courses of action for data collection enhancements or protocol edits
  • Facilitate meetings with the Study Director as necessary for study specific reports and suggest courses of action for data collection enhancements or protocol edits
  • Proofread study protocols prior to submission for the study director's signature
  • Compile study reports and documents and communicate to sponsors
  • Prepare report and electronic files for archiving if needed
  • Under the direction of the Supervisor, work on process improvement projects to enhance department efficiency, data collection, or data presentation specifically related to the implementation, training and utilization of new systems and software related to reporting
  • Work with technical staff for predetermining data reporting issues directly impacted by data collection


To qualify specifically for this role, you will have:
  • Bachelor's degree (B.A./B.S.) in journalism, computer science, physical sciences, business administration, or relateddisciplines
  • Scientific and medical writing knowledge and the ability to apply judgment and discretion to extract appropriate data and evaluate how to present it
  • Proficiency with spreadsheets, word processing, databases, and publishing software (e.g., MS Excel, Word, and AdobeAcrobatPDF software)
  • Ability to perform file conversion and compilation
  • Strong written, verbal, and analytical skills
  • Excellent organizational and communication skills. Ability to work with all levels of staff.
  • Ability to adjust priorities to adhere to stringent deadlines
  • Knowledge of medical terminology
  • Familiar with preclinical study protocols/reports and FDA electronic reporting compliance
  • Familiarity with Provantis system and Business Objects preferred
  • Knowledge of GLP (Good Laboratory Practices) regulations


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