Description

Job Summary

Responsible for the daily management/support of the Clinical Trials Management Software for the Nicklaus Children's Hospital Research Institute. Responsibilities include CTMS data entry, protocol/data updating, study calendar creation/development, budget shell creation/amending, data (metric/KPI) reporting, enrollment/screening dashboard updates, and collaboration with Research Institute Education on CTMS training/development. Serves as liaison to vendor partners and the Information Technology Department for shared system applications.

Job Specific Duties

• Communicates research study progress reports (including PT screenings, enrollments, etc.) to relevant hospital units involved with research including the establishment of a good rapport with NCHS department leaders.
• Responsible for the daily management/support (adds/edits/updates) of the Clinical Trails Management Software for the Nicklaus Children's Hospital Research Institute.
• Responsible for RI Metric/KPI reporting of critical CTMS data to research administration and Nicklaus senior leadership.
• Assists and collaborates with Research Institute Educator on CTMS training and development.
• Reviews, evaluates, tests, and triages application system updates/issues/cases, providing support as needed.
• Assists with creating budget shells/ financial schedules for new and existing (amended) study protocols.
• Responsible for new study and study amendment protocol calendar creation in CTMS.
• Assists with entering Research Patient information/data into CTMS within 72 hours of enrollment, patient visit or patient-related event.
• Complies with the Research Finance Compliance policies and procedures including reporting requirements to research finance staff.
• Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol.
• Provides ongoing troubleshooting and internal support for the RI suite of Cloud applications.
• Implements, designs, and provides support for the RI suite of Cloud applications.
• Follows NCHS RI's Standard Operating Procedures, HIPAA, and FDA guidelines for clinical research, and keeps updated on those procedures and/or guidelines.
• Assists with the collaboration with Research IT on research administrative related software/system, updates and purchases.
• Assists department leadership in establishing application baselines, benchmarks, goals, objectives, and necessary resources to reach them.

Qualifications

Minimum Job Requirements

• Bachelor's Degree in relevant field (Required)
• 2-4 years of research and healthcare data entry experience

Knowledge, Skills, and Abilities

• Experience in pediatric clinical research in a hospital setting preferred.
• Excellent communication skills in working with both children and adults.
• Excellent organizational skills, detail-oriented, people-oriented, flexible, and adaptable to change.
• Excellent time management skills.
• Knowledge of research protocols and research study-related processes.
• Software applications experience including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment.

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