Hybrid Clinical Research Data Specialist

University of Miami; United States; Hybrid; USD 55,000 - 75,000; Full time

Job summary

The University of Miami Health System is seeking a Full-Time Clinical Research Data Specialist to join the SCCC CRS team on a hybrid basis in Miami, Florida. The role focuses on creating and maintaining research charts and case report forms while ensuring compliance with SOPs and regulatory guidelines.

Your responsibilities will include extracting data from EMRs, managing study workloads, and coordinating with monitors to prepare for visits, while maintaining logs and study documentation in

Qualifications

• High school diploma or equivalent.
• No experience required.
• Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
• Ability to handle confidential information with discretion.
• Willingness to work evenings or weekends if necessary.
• Commitment to University values and teamwork.

Responsibilities

• Extracts clinical data and research data from EMRs and enters into data capture systems for each assigned study.
• Manages workload of studies commensurate to level of experience.
• Answers data clarifications (data queries) for each study.
• Schedules and coordinates with study monitors and ensures patient cases are ready for each monitor visit; issues addressed after monitoring visit.
• Develops source data worksheets specific to each assigned study.
• Maintains logs (e.g., TAS submissions, Velos) in accordance with SOPs.
• Participates in site initiation visits (SIV) and monitoring visits; collaborates with SDG and PI oversight meetings.
• Maintains study binders and filings per protocol requirements.

Job description

The University of Miami Health System is seeking a Full-Time Clinical Research Data Specialist to join the SCCC CRS team on a hybrid basis in Miami, Florida. The role focuses on creating and maintaining research charts and case report forms while ensuring compliance with SOPs and regulatory guidelines.

Your responsibilities will include extracting data from EMRs, managing study workloads, and coordinating with monitors to prepare for visits, while maintaining logs and study documentation in