Full-Time
Clinical Research Data Specialist
Updated on 8/1/2026
University of Miami
No salary listed
Company Does Not Provide H1B Sponsorship
Miami, FL, USA
In Person
Category
 Biology & Biotech (1) |
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Required Skills
Electronic Health Records (EHR)
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Requirements
- A high school diploma or equivalent is 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 evenings, nights, and weekends as necessary.
- Ability to work independently and/or in a collaborative environment.
- Adherence to University and unit-level policies and procedures and safeguarding of University assets.
Responsibilities
- Assist in creating, updating, and maintaining research charts and case report forms, including regulatory-related issues, in accordance with department standard operating procedures, under the supervision of the Principal Investigator and supervisor.
- Extract clinical and research data from electronic medical records and other sources and enter it into clinical paper-based or electronic data capture systems for assigned studies.
- Manage a workload of studies commensurate with experience.
- Answer data clarifications and data queries for each study.
- Schedule and meet with study monitors, ensure patient cases are ready for each monitoring visit, and address items after each visit.
- Develop source data worksheets specific to assigned studies.
- Address and close out clinical issues from monitoring reports before the next monitoring visit.
- Ensure study requirements are documented and meet internal and external regulations in accordance with protocol guidelines.
- Maintain logs, including TAS submissions and Velos logs, in a timely manner according to department standard operating procedures.
- Participate in site initiation visits, monitoring visits, site disease group team meetings, and Principal Investigator oversight meetings as required.
- Assist a multidisciplinary team in research activities.
- Maintain study binders and filings according to protocol requirements and department policy.
- Compile patient data for Investigator review to determine patient eligibility for protocol enrollment.
- Maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation, and other sponsor- or protocol-specific logs.
- Maintain an organized and efficient work environment.
- Participate in a collaborative work environment and support positive working relationships throughout the medical center.
- Adhere to University and department policies and procedures.