Clinical Research Data Specialist: Data Integrity

University of Miami; Miami (FL); On-site; USD 55,000 - 82,000; Full time

Job summary

University of Miami is seeking a Clinical Research Data Specialist to assist in creating, updating, and maintaining research charts and case report forms in accordance with SOPs. This role supports data compilation, submission, and monitoring for protocol adherence under PI supervision.

The position involves extracting data from EMRs and other sources, managing multiple studies, addressing data queries, and coordinating with monitors.

Qualifications

• High school diploma or equivalent required.
• Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
• Ability to process and handle confidential information with discretion.
• Willingness to work evenings, nights and weekends as necessary.

Responsibilities

• Extracts clinical data from EMRs and other sources and enters into data capture system.
• Manages workload commensurate to experience across studies.
• Answers data clarifications for each study.
• Schedules and coordinates with study monitors and ensures readiness for visits.
• Develops source data worksheets for assigned studies.
• Ensures data in monitoring reports is addressed and closed out.
• Maintains logs (e.g., TAS submissions, Velos) per SOPs.
• Participates in site initiation visits and monitoring visits as required.
• Assists multidisciplinary team in research activities.
• Maintains study binders and filings per protocol requirements.
• Adheres to UM and department policies and procedures.
• Compiles patient data for investigator review to determine eligibility.

Skills

Attention to detail

Data analysis

Discretion with confidential data

Evenings/nights/weekends flexibility

Independent and collaborative work

Education

High school diploma or equivalent

Job description

University of Miami is seeking a Clinical Research Data Specialist to assist in creating, updating, and maintaining research charts and case report forms in accordance with SOPs. This role supports data compilation, submission, and monitoring for protocol adherence under PI supervision.

The position involves extracting data from EMRs and other sources, managing multiple studies, addressing data queries, and coordinating with monitors.