Clinical Research Data Specialist - Data Integrity Leader

University of Miami; United States; On-site; USD 42,000 - 68,000; Full time

Job summary

University of Miami is seeking a Clinical Research Data Specialist to support data capture, regulatory compliance, and study coordination within the research portfolio. The role emphasizes accurate data entry from EMR sources, timely issue resolution, and maintenance of study logs and filings.

The position requires strong attention to detail, data analysis, and the ability to work both independently and with a team.

Qualifications

• Education: High school diploma or equivalent.
• Experience: no experience required.

Responsibilities

• Extracts clinical data from EMR and other sources into data capture systems.
• Manage workload commensurate to experience for assigned studies.
• Respond to data clarifications (queries) for each study.
• Coordinate with monitors; prepare patient cases for visits.
• Develop source data worksheets for each study.
• Address issues from monitoring reports and close out before next visit.
• Ensure study requirements meet protocol and regulatory standards.
• Maintain logs (e.g., TAS submissions, Velos) per SOPs.
• Participate in site initiation visits and monitoring visits; attend SDG/PI meetings.
• Assist multidisciplinary team in research activities.
• Maintain study binders and filings per protocol requirements.
• Adhere to UM and department policies and procedures.
• Compile patient data for Investigator review to determine eligibility.
• Maintain logs for screening, enrollment, adverse events, deviations, etc.
• Foster a collaborative, professional work environment and effective teamwork.
• The duties may expand to include other responsibilities as needed.

Skills

Attention to detail

Data analysis

Prioritization

Confidential information handling

Flexible schedule

Independent/collaborative work

Education

High school diploma or equivalent

Job description

University of Miami is seeking a Clinical Research Data Specialist to support data capture, regulatory compliance, and study coordination within the research portfolio. The role emphasizes accurate data entry from EMR sources, timely issue resolution, and maintenance of study logs and filings.

The position requires strong attention to detail, data analysis, and the ability to work both independently and with a team.