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Project Coordinator II - Infectious Diseases

Columbia University


Location:
New York, New York
Date:
08/30/2018
2018-08-302018-09-29
Categories:
  • Clinical Operations
Columbia University
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  • Research Salary

Job Details

The Project Coordinator will provide data management oversight and support for all research related matters at the Columbia Physicians & Surgeons Clinical Research Site (Columbia P&S CRS) as well as the Columbia Partnership Clinical Trials Unit (CTU). The Columbia CRS is part of a large inter-institutional CTU which encompasses four Clinical Research Sites (CRSs) located throughout Manhattan and the Bronx. Studies conducted at the Columbia P&S CRS include protocols sponsored by National Institutes of Health (NIH)-funded HIV/AIDS Clinical Trials Networks (AIDS Clinical Trials Group (ACTG), HIV Vaccine Trials Network (HVTN), as well as numerous industry studies in several areas: new drug development and translational research, optimization of antiretroviral therapy, and HIV Biomedical clinical trials. 

The Project Coordinator will coordinate day-to-day collection and reporting of clinical research data, data management, and quality control in accordance with study sponsor requirements for all studies conducted at the Columbia P&S CRS. Responsibilities will include maintenance and operation of database systems used in national NIH-funded Clinical Trials Networks as well as the management of a quality control (QC) system which will be used at the Columbia P&S CRS as well as across other CRSs in the CTU. 

Responsible for maintenance and operation of clinical trials database systems. Monitor a quality control (QC) system which is used across the CTU. Assist in the coordination of overall quality management (QM) procedures and contribute significantly to a QM Plan at the Columbia P&S CRS. Develop systems to improve data quality across the entire CTU. Work closely with the CTU staff to facilitate communication and track recruitment of patients/volunteers into the trials. Oversee entry/correction of study data for national networks and maintenance/design of data tracking systems. Provide analysis of data trends and outcomes, and assist with interpretation of data and preparation of reports. Also responsible for training additional staff members to assist with data entry and QC practices for the Columbia P&S CRS. Other responsibilities may include providing regulatory backup for clinical research protocols, including preparation of regulatory quality assurance protocols and communication with IRBs. Perform additional responsibilities as needed. 

Minimum Qualifications for Grade 
Applicant MUST meet these minimum qualifications to be considered an applicant 

Requires a bachelor's degree or equivalent in education and experience, plus three years of related experience. 

Additional Position-Specific Minimum Qualifications 
Applicant MUST meet these minimum qualifications to be considered an applicant 

Position requires an organized and detail-oriented person with the ability to prioritize and manage multiple projects. Excellent interpersonal and communication skills are essential. Proficiency in the use of Microsoft Word, Microsoft Access, Microsoft Excel, and the willingness to learn the use of national data management systems. 

Special Instructions 

Preferred Qualifications 

Knowledge of HIV and clinical research preferred. Spanish Language also a plus. Working knowledge of common national data management systems including Medidata/Rave and iDataFax is a plus. 

Essential Functions 

Additional Essential Functions (Limit to 3950 characters.) 

Special Indications 

This position works with:
Contact with patients and/or research subjects 

HIPAA Compliance training required 

Yes 

Participation in Medical Surveillance required 

No Response 

What type of posting? Is this a waiver request? 

Standard Posting 

Requisition Open Date 

05-01-2018 

Requisition Close Date 

Open Until Filled 

Quick Link 

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