Compliance Core Coordinator
Herbert Irving Comprehensive Cancer Center – Clinical Protocol and Data Management office
SCOPE: 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.
(Applicant MUST meet these minimum qualifications to be considered an applicant):
- Bachelor’s degree or equivalent in education, training, and experience
- Three years of related, clinical research experience
- 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
To apply: https://opportunities.columbia.edu/en-us/job/514724/compliance-core-coordinatoror
email: [email protected]
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