Clinical Trials Management Systems – Data Specialist (Full Time, Day shift)

Miami, Florida, 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, protocol digitization, 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. 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 with creating budget shells/schedules for new and existing (amended) study protocols.   Responsible for new study and study amendment protocol digitization and creation of study visit calendar in CTMS.   Assists and collaborates with Research Institute Educator on CTMS training and development.   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, AAHRPP, HIPAA and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines.   Assists with entering Research Patient information/data into CTMS within 72 hours of enrollment, patient visit or patient-related event.   Receives and processes new studies through the CTMS digitization process and updates the necessary research staff of updates.   Qualifications Minimum Job Requirements 2 years of research and healthcare data entry experience Knowledge, Skills, and Abilities Associate’s degree or medical/technical school preferred. Experience in pediatric clinical research in a hospital setting preferred. Bilingual in English/Spanish preferred. Clinical research certification (CCRC, CCRP, CRA) and IATA certification 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. Job : Research Primary Location : Florida-Miami-Nicklaus Children’s Hospital – Main Hospital Campus Department : RI – ADMINISTRATION-2100-380950 Job Status :Full Time

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