Description

JOB DESCRIPTION

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.

QUALIFICATIONS

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.

ABOUT US

At Atlantic Health, our promise to our communities is; Anyone who enters one of our facilities will receive the highest quality care delivered at the right time, at the right place, and at the right cost. This commitment is also echoed in the respect, development and opportunities we give to our more than 22,000 team members. Headquarters in Morristown, New Jersey, we are one of the leading non-profit health care systems in the nation. Our facilities and sites of care include:

• Atlantic Health Morristown Medical Center, Morristown, NJ
• Atlantic Health Overlook Medical Center, Summit, NJ
• Atlantic Health Newton Medical Center, Newton, NJ
• Atlantic Health Chilton Medical Center, Pompton Plains, NJ
• Atlantic Health Hackettstown Medical Center, Hackettstown, NJ
• Atlantic Health Goryeb Children's Hospital, Morristown, NJ
• Atlantic Health CentraState Healthcare System, Freehold, NJ
• Atlantic Medical Group
• Atlantic Visiting Nurse
• Atlantic Mobile Health
• Atlantic Rehabilitation

We have more than 900 community-based healthcare providers affiliated through Atlantic Medical Group.

We have received awards and recognition for the services we have provided to our patients, team members and communities. Below are just a few of our accolades:

• Chosen for 17 years by Fortune as one of the magazine's "100 Best Companies to Work For."
• Atlantic Health Morristown and Atlantic Health Overlook Named by Newsweek as two of the "World's Best Hospitals" in 2026.
• Atlantic Health Morristown and Atlantic Health Overlook ranked within the top three hospitals in New Jersey by U.S. News & World Report's 2025-2026 Best Hospital rankings.
• Atlantic Health scored four "A" grades by The Leapfrog Group in its Fall 2025 Hospital Safety Grades, performance measures reflecting errors, accidents, injuries and injections, as well as systems hospitals have in place to prevent harm.
• Atlantic Health Morristown and Atlantic Health Overlook are New Jersey's only hospitals to be named among America's 50 Best hospitals by Healthgrades in 2026.
• Named by Becker's Healthcare as one of the "165 Top Places to Work in Healthcare - 2026.
• Atlantic Health Morristown, Atlantic Health Overlook, Atlantic Health Chilton and Atlantic Health Newton all Forbes Top Hospitals for 2026.
• Named by Newsweek as one of America's Greatest Workplaces for Inclusion & Diversity 2025.
• Atlantic Health rated LEVEL 9 - 2025 CHIME Digital Health Most Wired.

Morristown Medical Center is a nationally-recognized leader in cardiology and heart surgery, orthopedics, gynecology, geriatrics, gastroenterology and GI surgery, pulmonology and lung surgery, and urology.

We are the only hospital in New Jersey named one of America's '50 Best Hospitals' for six consecutive years by Healthgrades and one of the World's Best Hospitals by Newsweek. We were included on Becker's Healthcare 2020 list of "100 Great Hospitals in America". In addition, Leapfrog recognized us with an "A" hospital safety grade - its highest - twelve consecutive times, and the Centers for Medicare and Medicaid Services awarded us again with its highest five-start rating in 2020.

Morristown Medical Center is a Magnet Hospital for Excellence in Nursing Service, the highest level of recognition achievable from the American Nurses Credentialing Center for facilities that provide acute care services. Our nonprofit hospital was also designated a Level I Regional Trauma Center by the American College of Surgeons and a Level II by the State of NJ.

Atlantic Health offers a competitive and comprehensive Total Rewards package that supports the health, financial security, and well-being of all team members. Offerings vary based on role level (Team Member, Director, Executive). Below is a general summary, with role-specific enhancements highlighted:

Team Member Benefits

• Medical, Dental, Vision, Prescription Coverage (22.5 hours per week or above for full-time and part-time team members)
• Life & AD&D Insurance.
• Short-Term and Long-Term Disability (with options to supplement)
• 403(b) Retirement Plan: Employer match, additional non-elective contribution
• PTO & Paid Sick Leave
• Tuition Assistance, Advancement & Academic Advising
• Parental, Adoption, Surrogacy Leave
• Backup and On-Site Childcare
• Well-Being Rewards
• Employee Assistance Program (EAP)
• Fertility Benefits, Healthy Pregnancy Program
• Flexible Spending & Commuter Accounts
• Pet, Home & Auto, Identity Theft and Legal Insurance

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Note: In Compliance with the NJ Pay Transparency Act (effective Sunday, June 1, 2025), all job postings will include the hourly wage or salary (or a range), as well as this summary of benefits. Final compensation and benefit eligibility may vary by role and employment status and will be confirmed at the time of offer.

EEO STATEMENT

Atlantic Health, Inc. is an equal employment opportunity employer and federal contractor or subcontractor and therefore abides by applicable laws to protect applicants and employees from discrimination in hiring, promotion, discharge, pay, fringe benefits, job training, classification, referral, and other aspects of employment, on the basis of race, color, religion, sex (including pregnancy, gender identity and sexual orientation), national origin, citizenship status, disability, age, genetics, or veteran status.