Clinical Research Data Specialist

About the role

The University of Miami/UHealth Department of SCCC is seeking a full‑time Clinical Research Data Specialist to support multiple research studies on the UHealth campus in Miami, FL. Working under the supervision of the Principal Investigator, you will ensure accurate data capture, regulatory compliance, and smooth coordination with study monitors.

Key responsibilities

• Extract clinical and research data from electronic medical records and other sources, entering it into paper‑based or electronic data capture systems for each assigned study.
• Manage a workload of studies appropriate to experience level and respond to data queries.
• Schedule and prepare for study monitor visits, ensuring patient cases are ready and issues are resolved.
• Develop source data worksheets and maintain study logs (e.g., TAS submissions, Velos) in accordance with SOPs.
• Participate in site initiation visits, monitoring visits, and multidisciplinary team meetings.
• Maintain study binders, filings, and documentation to meet internal and external regulatory requirements.
• Compile patient data for eligibility review and track screening, enrollment, adverse events, and other protocol‑specific logs.

Required profile

• Experience extracting and entering clinical data from EMR systems.
• Ability to manage multiple studies and meet monitoring deadlines.
• Familiarity with standard operating procedures, regulatory guidelines, and protocol compliance.
• Strong organizational skills to maintain accurate study documentation.

Required skills

• Electronic Medical Records (EMR) systems
• Electronic Data Capture (EDC) systems