Monitor donor medical records through manual and electronic tracking systems until Quality Assurance review is complete.
Ensure complete, accurate, and timely collection of donor records from hospitals, transplant centers, laboratories, and other Organ Procurement Organizations.
Maintain donor documentation in DonorNet, iTransplant, and related databases.
Review donor records and clinical documentation for accuracy, consistency, completeness, and compliance with applicable regulations and organizational standards.
Maintain confidentiality and security of donor, recipient, and patient health information.
Prepare, coordinate, and submit required reports and data to regulatory and professional organizations, including OPTN, UNOS, AOPO, CMS, and other assigned agencies.
Assist with regulatory audits, surveys, accreditation activities, and compliance reviews.
Maintain current knowledge of regulatory requirements related to donor record management, reporting, and quality systems.
Identify potential compliance concerns and escalate issues appropriately.
Conduct routine audits of donor records and data systems to ensure data integrity and regulatory compliance.
Analyze clinical and operational data to identify trends, opportunities, and areas for improvement.
Develop, maintain, and distribute reports, dashboards, and performance metrics for leadership review, including OPO Yield Calculator data.
Serve as the departmental subject matter expert for iTransplant and other assigned clinical information systems.
Maintain the Donor Management Guideline portal database and associated records.
Identify opportunities to improve workflows, reporting capabilities, and system utilization.
Assist with testing, implementation, validation, and optimization of new technologies, software enhancements, and system upgrades.
Knowledge of and ability to navigate electronic medical records.
Competence with Microsoft Office products and advanced proficiency in Excel.
Five or more years of experience in Organ Services.
Associate's degree may be acceptable with applicable experience.
Responsibilities
Lead or participate in process improvement initiatives supporting Organ Services and Clinical Affairs operations.
Assist leadership with special projects involving data collection, analysis, implementation, and performance monitoring.
Serve as a resource and mentor to Clinical Information Specialists and other team members.
Assist with onboarding, training, and competency development for new staff.
Provide guidance on donor record management processes, documentation standards, and departmental procedures.
Support leadership in maintaining standardized practices and operational consistency across the department.
Serve as project lead for departmental initiatives and cross-functional assignments when needed.
Build and maintain professional relationships with internal and external stakeholders.
Meet established goals, objectives, and deadlines in a timely and effective manner.
Attend scheduled work, meetings, training sessions, and other organizational functions.
Perform additional duties, assignments, and special projects as required.
Desired Qualifications
Two or more years of experience in Quality Assurance and/or Regulatory Affairs.
Bachelor's degree in a healthcare-related field.
Quality certification such as ASQ or Six Sigma.
Description
The Senior Clinical Information Specialist supports the mission, goals, and strategic plan of South Florida Donor Network (SFDN) by serving as a subject matter expert for clinical data management and donor record processes within Organ Services. This position provides advanced oversight of clinical information tracking, regulatory reporting, data integrity, quality assurance, process improvement initiatives, and system optimization. The Senior Clinical Information Specialist serves as a resource to staff, assists with training and onboarding, and collaborates with leadership to identify opportunities to improve operational efficiency, compliance, and data quality.
Requirements
Essential Duties and Responsibilities
Donor Record Management & Quality Assurance
Monitor the status of donor medical records through manual and electronic tracking systems until Quality Assurance review is complete.
Ensure complete, accurate, and timely collection of donor records from hospitals, transplant centers, laboratories, and other Organ Procurement Organizations (OPOs).
Maintain donor documentation in applicable systems, including DonorNet, iTransplant, and related databases.
Review donor records and clinical documentation for accuracy, consistency, completeness, and compliance with applicable regulations and organizational standards.
Receive, document, and communicate donor culture and biopsy results to support patient safety and clinical decision-making.
Maintain confidentiality and security of donor, recipient, and patient health information.
Regulatory Compliance & Reporting
Prepare, coordinate, and submit required reports and data to regulatory and professional organizations, including OPTN, UNOS, AOPO, CMS, and other agencies as assigned.
Assist with regulatory audits, surveys, accreditation activities, and compliance reviews.
Maintain current knowledge of regulatory requirements related to donor record management, reporting, and quality systems.
Identify potential compliance concerns and escalate issues appropriately.
Conduct routine audits of donor records and data systems to ensure data integrity and regulatory compliance.
Data Analysis & Performance Improvement
Analyze clinical and operational data to identify trends, opportunities, and areas for improvement.
Develop, maintain, and distribute reports, dashboards, and performance metrics for leadership review, including OPO Yield Calculator data.
Lead or participate in process improvement initiatives that support Organ Services and Clinical Affairs operations.
Assist leadership with special projects involving data collection, analysis, implementation, and performance monitoring.
Clinical Information Systems & Technology Support
Serve as the departmental subject matter expert for iTransplant and other assigned clinical information systems.
Maintain the Donor Management Guideline (DMG) portal database and associated records.
Identify opportunities to improve workflows, reporting capabilities, and system utilization.
Assist with testing, implementation, validation, and optimization of new technologies, software enhancements, and system upgrades.
Training, Mentorship & Team Support
Serve as a resource and mentor to Clinical Information Specialists and other team members.
Assist with onboarding, training, and competency development for new staff.
Provide guidance on donor record management processes, documentation standards, and departmental procedures.
Support leadership in maintaining standardized practices and operational consistency across the department.
May serve as project lead for departmental initiatives and cross-functional assignments.
General Responsibilities
Build and maintain professional, effective relationships with internal and external stakeholders.
Meet established goals, objectives, and deadlines in a timely and effective manner.
Attend work, meetings, training sessions, and other organizational functions as scheduled.
Perform additional duties, assignments, and special projects as required.
Skills: Knowledge of and ability to navigate through electronic medical records, organization and analytical skills, competent in MS office products, and highly skilled in Excel.
Experience: Leadership and/or trainer experience, worked 5 or more years in Organ Services required, 2+ years working in Quality Assurance and/or Regulatory Affairs preferred.
Education: Bachelor’s in health care related field preferred, Associate’s degree may be acceptable with applicable experience. Quality Certification like ASQ or Six Sigma a plus!
Key Competencies for Success
Quality/Regulatory Compliance Expertise
Clinical Data Accuracy and Integrity
Analytical and Reporting Capability
Database Systems Expertise (e.g., DonorNet/iTransplant)