Registered Nurse; Oncology Data Coordinator Immune Effector Cellular Therapy (IEC) Program- Part Ti

The Oncology Data Coordinator is responsible for the collection, management, auditing, regulatory reporting, and quality oversight of clinical and registry data for the Immune Effector Cellular Therapy (IEC) Program. This role ensures the accurate and timely submission of required data to the Center for International Blood & Marrow Transplant Research (CIBMTR), FACT/JACIE accreditation bodies, regulatory agencies, and institutional quality programs.

The Oncology Data Coordinator serves as a key contributor to the IEC Quality Management Program by conducting audits, analyzing trends, developing corrective and preventive action plans (CAPAs), supporting accreditation activities, and ensuring compliance with regulatory and institutional standards.

Principal Responsibilities: 

Regulatory Data Management: 

• Collect, maintain, validate, and submit complete and accurate clinical and regulatory data required for CIBMTR reporting.
• Perform timely data entry and management within CIBMTR FormsNet3 and other required databases.
• Ensure compliance with FACT, JACIE, institutional, sponsor, and regulatory reporting requirements.
• Obtain and document patient consent for registry participation, as applicable.
• Collect and maintain patient treatment and follow-up data, including:
  • Adverse Events (AEs)
  • Serious Adverse Events (SAEs)
  • Toxicity management outcomes
  • Treatment milestones
  • Clinical outcomes data
  • Additional required regulatory data elements

Quality Management & Auditing:

• Coordinate and facilitate quarterly IEC Quality Management meetings.
• Conduct quarterly internal audits to ensure data accuracy, completeness, and regulatory compliance.
• Audit clinical program records, CIBMTR submissions, regulatory documentation, and external facility records.
• Identify trends, deficiencies, and opportunities for process improvement through audit findings.
• Maintain comprehensive audit records, meeting minutes, action plans, and required documentation.
• Monitor data discrepancies, occurrences, and deviations to support continuous quality improvement initiatives.

Corrective & Preventative Management:

• Develop, implement, and monitor CAPAs related to audit findings and quality concerns.
• Conduct root cause analyses to identify underlying causes of data errors or compliance issues.
• Evaluate CAPA effectiveness through ongoing monitoring and follow-up audits.
• Document investigations, corrective actions, and long-term preventive strategies.
• Ensure all CAPA activities meet FACT/JACIE quality standards.

Reporting & Program Oversight: 

• Prepare quarterly and annual quality management reports for program leadership and stakeholders.
• Present audit findings, quality metrics, trend analyses, and improvement initiatives.
• Report serious or unexpected adverse events to regulatory bodies and program stakeholders as required.
• Support accreditation reviews, inspections, and regulatory audits.

Compliance & Professional Development: 

• Maintain compliance with all IEC Quality Management Program requirements.
• Participate in ongoing continuing education related to cellular therapy, oncology data management, and regulatory standards.
• Utilize educational resources from CIBMTR and FACT Data Management Resource Centers.
• Maintain competency in regulatory requirements, institutional policies, and data management systems.

Required

• Bachelor's degree in Nursing, Health Sciences, Public Health, Biological Sciences, or a related field.
• Minimum of two (2) years of experience in cellular therapy, blood and marrow transplant, oncology, clinical research, or healthcare data management.
• Experience with CIBMTR reporting requirements and FormsNet3.
• Knowledge of FACT/JACIE standards and regulatory requirements.
• Experience conducting audits, quality reviews, or quality management activities.
• Strong analytical, organizational, problem-solving, and communication skills.

• Ability to manage multiple priorities while maintaining a high level of accuracy and attention to detail.

   

Preferred

• CTR, CCRP, CCRC, or related professional certification.
• Experience supporting Immune Effector Cellular Therapy (CAR-T) programs.
• Experience with CAPA development, quality investigations, and root cause analysis methodologies.
• Familiarity with Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), and sponsor reporting requirements.
• Experience working within accredited oncology, transplant, or cellular therapy programs.