Apple Macs, Biotech and Pharmaceutical, Cancer, Case Report Form (CRF), Clinical Research, Clinical Trial, Computer Skills, Department of Health and Human Services, Disease Investigation, FDA (Food and Drug Administration), Federal Laws and Regulations, File Maintenance, GCP (Good Clinical Practices), IRB/IEC (Institutional Review Board/Independent Ethics Committee), Interpersonal Skills, Leadership, Maintain Compliance, Medical Terminology, Medical Treatment, Microsoft Word, Oncology, Organizational Skills, Project Tracking, Quality Assurance, Quality Assurance Methodology, Quality Control, Quality Management, Quality Monitoring, Registrar, Reporting Skills, Research Skills, Safety/Work Safety
Compliance Core Coordinator
- 557146
- Parker Plaza (Fort Lee, NJ)
- Herbert Irving Comprehensive Cancer Center
- Full Time
- Opening on: May 9 2026
- Grade 104
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- Job Type: Officer of Administration
- Bargaining Unit:
- Regular/Temporary: Regular
- End Date if Temporary:
- Hours Per Week: 35
- Standard Work Schedule:
- Building:
- Salary Range: $78,000 - $81,000
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University''s good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position Summary
The Compliance Coordinator performs the daily activities necessary to ensure both compliant and ethical clinical trials research conducted within the CPDM. This position reports directly to the Research Manager, Quality Assurance and Safety.
This position work location is at 400 Kelby St. Fort Lee, NJ.
Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.
Responsibilities
The Compliance Core Coordinator responsibilities include, but are not limited to:
- Serves as Central Registrar.
- Reviewing Central Registration submission documents for accuracy and comprehensiveness prior to registering any research subject into the HICCC institutional database.
- Performing monitoring activities and quality control on designated protocols to ensure adherence to the IRB approved study procedures, Human Subject Protection Federal Regulations, GCP, and local CUMC institutional policies.
- Presenting findings internally to both the Research Manager, Quality Assurance and Safety. as well as other CPDM leadership personnel.
- Generating reports to all necessary parties on the progress of monitoring projects and Central Registration accruals.
- Maintaining central file archiving for all Central Registration and Monitoring activities
- Working with a variety of studies, across multiple disease groups (Studies will range from National Cancer Institute (NCI) Cooperative Group trials (e.g., Alliance, RTOG, SWOG, etc), pharmaceutical sponsored trials, and investigator-initiated Sponsor/Investigator trials).
- Perform other related duties and responsibilities as assigned/requested.
Minimum Qualifications
- Bachelor's degree or equivalent in education, training, and experience and three years of related, clinical research experience
Preferred Qualifications
- Experience with Human Subjects clinical research QA/monitoring processes and audit procedures.
- Excellent interpersonal and organizational skills.
- Ability to take initiative and work independently.
- Computer Skills: proficiency with MS Word programs and familiarity with Mac and PC platforms.
- Extensive knowledge of GCP, FDA, and DHHS policies.
- Experience with paper Case Report Forms (CRFs) and/or electronic research databases.
- Knowledge of medical terminology and procedures specifically related to oncology.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.