Compliance Core Coordinator

• 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

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.