Clinical Data Steward – Transplant Research & Compliance

University of Miami

Miami (FL)

On-site

USD 65,000 - 90,000

Full time

2 days ago
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Benefits offered by this job

Competitive salaries

Job summary

The University of Miami Health System is seeking a Research Data Manager (Medical) to support the Adult Transplantation and Cellular Therapy Program (TCTP) in collecting, abstracting, and submitting patient data to NMDP and CIBMTR. The role emphasizes data integrity, compliance, and timely reporting.

You will coordinate with data coordinators, nurses, and providers, conduct audits, and train staff, ensuring accuracy for regulatory submissions and audits by bodies like NMDP, CIBMTR, and FACT.

Qualifications

  • AS or Bachelor Degree, preferably in nursing or healthcare or science related field.
  • CITI Certification within 30 days of hire required.
  • A minimum of three years of effective work-related experience in hematology/oncology, research compliance or study coordination and auditing.
  • High-level interpersonal skills are required.
  • Professional certification/licensure in nursing, clinical research, research compliance, auditing, GCP-related field preferred.

Responsibilities

  • Gather, abstract and submit patient data per NMDP and CIBMTR.
  • Monitor timeliness and accuracy of data submission as per CPI.
  • Coordinate with CIBMTR, NMDP and data coordinators/peers from other institutions.
  • Meet with TCTP providers to review collected data.
  • Develop processes for obtaining external data from referring physicians’ offices.
  • Ensure data gathered prior to transplant submissions to CIBMTR.
  • Conduct routine audits to ensure compliance and data integrity.
  • Assist with audits and regulatory agency submissions and responses.
  • Train other Research Data Managers.
  • Maintain Data Management policies and SOPs.

Skills

Microsoft Excel
Microsoft Word
Microsoft Access
PowerPoint
Data analysis
Communication skills
Attention to detail
Problem solving

Education

AS or Bachelor Degree in nursing/healthcare/science

Job description

The University of Miami Health System is seeking a Research Data Manager (Medical) to support the Adult Transplantation and Cellular Therapy Program (TCTP) in collecting, abstracting, and submitting patient data to NMDP and CIBMTR. The role emphasizes data integrity, compliance, and timely reporting.

You will coordinate with data coordinators, nurses, and providers, conduct audits, and train staff, ensuring accuracy for regulatory submissions and audits by bodies like NMDP, CIBMTR, and FACT.

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