Senior CTMS Analyst - Oncology

Nicklaus Children's Health System; Miami (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Nicklaus Children's Health System in Miami, FL seeks a Senior Oncology CTMS Analyst to manage the Clinical Trials Management Software for the Research Institute. The role covers data entry, study calendar creation, budget shells, and KPI reporting to research administration and leadership.

You will serve as a liaison to vendors and IT, mentor team members, and support CTMS training and development. Relocation is possible for qualified candidates; daytime schedule.

Qualifications

• Bachelor's degree in a relevant field.
• 4 years of experience in research and healthcare data entry.
• Experience with CTMS or clinical trials systems preferred.

Responsibilities

• Manage CTMS data entry and updates.
• Create study calendars and budget shells.
• Produce metric/KPI reports for leadership.
• Liaise with vendors and IT for system issues.
• Mentor staff and collaborate on CTMS training.
• Ensure compliance with SOPs, HIPAA, and FDA guidelines.

Skills

Pediatric clinical research

Communication skills

Organizational skills

Knowledge of research protocols

Software applications

Education

Bachelor's Degree in relevant field

Job description

Senior CTMS Analyst Oncology (Full Time, Days)

Miami, Florida

South Florida based position. We will also consider candidates that are willing to relocate.

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.

Qualifications

• 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.
• 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.