Job Description

The Compliance Core Coordinator helps perform the daily activities necessary to ensure both compliant and ethical clinical trials research conducted within the CPDM. This position reports directly to the Compliance Core Manager.

DESCRIPTION:

The Compliance Core Coordinator serves as a Central Registrar for the Compliance Core’s Central Registration Office.

Responsibilities include, but are not limited to:

·         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 CPDM Compliance Core Manager 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).

·         Coordinator performs other related duties and participates in special projects as assigned.

Company Description

The Herbert Irving Comprehensive Cancer Center Clinical Protocol and Data Management office is a centralized office composed of well-trained regulatory, nursing, study management, and compliance personnel who promote uniformity and consistency in clinical research by providing support for principal investigators and patients.