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. The role focuses on accurate data extraction, entry, and management to ensure compliance with study protocols and regulatory standards.

Key responsibilities

• Extract clinical and research data from electronic medical records and other sources, entering it into paper‑based or electronic data capture (EDC) systems for each assigned study.
• Manage a workload of studies appropriate to experience level and respond to data queries.
• Schedule and coordinate study monitor visits, preparing patient cases and addressing monitoring findings.
• 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 various sponsor‑specific logs (screening, enrollment, adverse events, etc.).
• Compile patient data for eligibility review and ensure all documentation meets internal and external regulations.

Required profile

• High school diploma or equivalent.
• Ability to manage multiple studies and meet deadlines.
• Strong attention to detail and adherence to SOPs and regulatory guidelines.

Required skills

• Experience with Electronic Medical Records (EMR) systems.
• Proficiency in Electronic Data Capture (EDC) platforms.