Job Summary
The Senior Oncology CTMS Analyst will be 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 Trials Management Software for the Nicklaus Children's Research Institute.
- Responsible for RI Metric/KPI reporting of critical CTMS data to research administration and Nicklaus senior leadership.
- Translates user requirements into functional and technical design specifications and reviews with client(s) to ensure accuracy.
- Leads small to medium complexity for the RI suite of Cloud applications - upgrade, initiatives, or enhancements to workflows, including the design, build, and test phases.
- Serves as a mentor/subject matter expert to internal and external clients and/or team members.
- Assists and collaborates with the Research Institute Educator on CTMS training and development.
- Creates 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.
- Follows NCHS RI's Standard Operating Procedures, HIPAA, and FDA guidelines for clinical research, and keeps updated on those procedures and/or guidelines.
- Collaborates 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.
Minimum Job Requirements
- Bachelor's Degree in relevant field
- 4 years of experience in research and healthcare data entry
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.