4 years of experience in research and healthcare data entry
Experience in pediatric clinical research in a hospital setting preferred
Excellent communication skills with diverse populations
Strong organizational and time management skills
Familiarity with research protocols and related processes
Proficient in a range of software applications including data entry and management tools
Responsibilities
Manage daily operations of Clinical Trials Management Software (CTMS)
Communicate study progress to relevant hospital departments
Generate and report metrics/KPIs for research leadership
Translate user requirements into design specifications
Lead upgrades and enhancements for cloud applications
Mentor team members as a subject matter expert
Collaborate on CTMS training and development
Create budget shells for study protocols
Build and maintain study calendars in CTMS
Ensure compliance with research finance policies
Utilize Good Clinical Practices in clinical trial conduct
Work with Research IT on software updates and purchases
Benefits
Professional development opportunities
Mentorship from experienced professionals
Collaborative work environment
Access to advanced research technology
Contribution to impactful pediatric healthcare research
Full Job Description
Description
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
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.
About Nicklaus Children's Health System
Nicklaus Children's Health System is a non-profit organization that provides pediatric care and services to children in South Florida. The organization was founded in 1950 and has since grown to become one of the largest pediatric healthcare systems in the region. Nicklaus Children's Health System is dedicated to providing high-quality, family-centered care to children of all ages, from newborns to young adults. The organization offers a wide range of services, including emergency care, surgery, rehabilitation, and more. Nicklaus Children's Health System is committed to advancing pediatric medicine through research and education, and is affiliated with several leading medical schools and research institutions.