Clinical Research Data Specialist

University of Miami - Miami, FL

Full-time - Entry Level

Miami, FL

Educational Services

About the position

The Clinical Research Data Specialist at the University of Miami/UHealth Department of SCCC plays a crucial role in supporting clinical research by managing and maintaining research charts and case report forms. This position involves ensuring compliance with regulatory standards and departmental procedures under the supervision of the Principal Investigator. The specialist will extract and enter clinical data, monitor study compliance, and assist in various research activities, contributing to the overall success of clinical trials.

Responsibilities

• Extracts clinical data and research data from electronic medical records and other sources.
• Enters data in the clinical paper-based or electronic data capture system for each assigned study.
• Manages a workload of studies commensurate to level of experience.
• Answers data clarifications (i.e. data queries) for each study.
• Schedules and meets with study monitors, ensuring patient cases are ready for each monitor visit.
• Develops source data worksheets specific to each assigned study.
• Addresses and closes out clinical issues from monitoring reports before the next monitoring visit.
• Documents all study requirements to meet internal and external regulations in accordance with protocol guidelines.
• Maintains logs (i.e. TAS submissions, Velos etc.) in a timely manner according to department SOPs.
• Participates in site initiation visits (SIV), monitoring visits, and site disease group (SDG) team and PI oversight meetings as required.
• Assists multidisciplinary team in research activities.
• Maintains study binders and filings according to protocol requirements and department policy.
• Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment.
• Maintains various logs related to screening, enrollment, adverse events, and other protocol-specific requirements.
• Ensures work environment is organized and functions efficiently.
• Participates in a collaborative, empowered work environment through teamwork.

Requirements

• High school diploma or equivalent required.
• Skill in completing assignments accurately and with attention to detail.
• Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
• Ability to process and handle confidential information with discretion.
• Ability to work independently and/or in a collaborative environment.

Nice-to-haves

• Ability to work evenings, nights, and weekends as necessary.
• Commitment to the University's core values.

Benefits

• Competitive salaries
• Comprehensive benefits package including medical and dental insurance
• Tuition remission