ICON plc

eCOA Analyst

ICON plc

full-time

Posted on:

Location: 🇺🇸 United States

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Job Level

Mid-LevelSenior

About the role

  • Support all COAs (Clinician Reported Outcomes, Patient Reported Outcomes, Observer Reported Outcomes, & Performance Outcomes)
  • Assist in the implementation of eCOA and paper-based COA during clinical trial execution
  • Act as a core team member for eCOA development, including device testing, deployment, and ongoing maintenance
  • Provide expertise on PRO/COA scientific principles to ensure consistency across Therapeutic Areas and integration among eCOA vendors
  • Ensure ongoing quality, precision, and integrity of COA instruments throughout clinical trials
  • Contribute to vendor selection processes and provide input
  • Participate in specification meetings to support design of ePRO application and monitoring reports
  • Review and approve ePRO specifications, screens, and prototypes; escalate concerns to PRO lead when necessary
  • Develop and execute the PRO Completion Guidelines
  • Serve as key member of User Acceptance Testing (UAT): execute cases, document issues, collaborate with cross-functional partners for resolution
  • Share best practices and lessons learned across studies, Therapeutic Areas, and teams
  • Contribute to documentation that enhances COA processes (training materials, responsibility matrices)
  • Monitor compliance metrics impacting PRO/COA quality
  • Stay informed on scientific and industry best practices related to PRO/COA

Requirements

  • An undergraduate degree from an accredited institution or international equivalent required
  • Read, write and speak English
  • Four plus years of experience in CRO or healthcare related industry
  • Proficient in Microsoft Office
  • Working knowledge of Patient Focused Drug Development (PFDD) and 2009 PRO FDA Guidance and other relevant guidance and best practices is preferred
  • Strong interpersonal skills and demonstrated ability to work effectively as a member of cross-functional teams
  • Expertise working with eCOA/COA/ePRO
  • Strong analytical skills with a keen eye for detail
  • Excellent listening, verbal, and written communication skills
  • Ability to work independently and to involve management when needed
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