Clinical Informatics Specialist

Conduct clinical research in compliance with GCDMP, ICH GCP, and FDA 21 CFR Part 11 while performing comprehensive protocol evaluations for IRB submission. Provide detailed protocol information and identify key data collection points for ClinSpark electronic case report forms (eCRFs), ensuring alignment with IRB-approved documents and study requirements. Execute quality control reviews of study data collection forms, activity worksheets, and EDC case report forms against protocols, and complete ClinSpark User Acceptance Testing. Serve as the primary liaison for departmental modifications to eCRFs, confirm IRB and Sponsor approvals prior to study activation, and maintain all final plans and logs for TMF filing. Collaborate with Laboratory, Pharmacy, Clinical Operations, and Project Management teams to ensure database build timelines are met and study processes remain compliant.