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.
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.
Bachelor???s degree or equivalent in education, training, and experience, plus three years of related experience
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
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
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.