Clinical Research Data Specialist

Responsibilities

• Extracts clinical data and research data from electronic medical records and other sources and enters this 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 and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit
• Develops source data worksheets specific to each assigned study
• Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit
• Assures all study requirements are documented and meet both 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 participates in 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
• Adheres to all UM and department policies and procedures
• Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment
• Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs
• Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center
• Adheres to University and unit-level policies and procedures and safeguards University assets

Benefits

• Competitive salaries
• A comprehensive benefits package including medical, dental, tuition remission and more
• Glassdoor
• 3.9
• University of Miami is a public research university that provides undergraduate, graduate, and professional degree programs.
• Miami, Florida, USA
• https://welcome.miami.edu
• Late Stage
• Total Funding
• $7.82M
• Key Investors
• Angel Alvarez
• National Oceanic and Atmospheric Administration
• Health Foundation of South Florida
• 2024-02-06
• Grant· $5M
• 2023-11-16
• Grant· $1.8M
• 2023-02-14
• Grant· $1M
• Leadership Team
• William Devoney
• Health System Chief Financial Officer
• Brad Rohrer
• Vice President for Information Technology and Chief Information Officer
• Recent News
• contxto.com
• The Miami accelerator opening doors for Latin American founders
• 2026-08-05
• miami.edu

Qualifications

• High school diploma or equivalent
• 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
• Commitment to the University's core values
• Ability to work independently and/or in a collaborative environment

Required skills

• Clinical data extraction, Clinical paper-based data capture, Clinical research documentation, Data entry, Electronic data capture systems, Electronic medical records, Log maintenance, Protocol adherence, Regulatory compliance, Source data worksheet development, Study monitoring, analyze and prioritize work

Preferred skills

• handle confidential information with discretion

Experience

• Entry level