Studies conducted in the CRU include protocols sponsored by National Institutes of Health, investigator initiated studies, both inpatient and outpatient, as well as numerous industry studies in several areas: new drug development and translational research in COVID-19 and HIV, optimization of antiretroviral therapy, and COVID-19 and HIV Biomedical clinical trials for treatment and prevention.
The Data Coordinator will be responsible for the day-to-day collection and reporting of clinical research data, data management, and quality control (QC) in accordance with study sponsor requirements for NIH-funded COVID Prevention Network (CoVPN), ACTG, and HVTN studies conducted at the CRU. Responsibilities will include maintenance and operation of database systems used in national NIH-funded Clinical Trials Networks as well as the management of a QC system, which will be used at the CRU and other sites in the clinical trials unit.
Maintain and operate clinical trials database systems.
Perform QC and monitor a QC system (internal and in coordination with other CTU sites).
Assist in the coordination of overall quality management (QM) procedures and contribute significantly to a QM Plan at the CRU.
Develop systems to improve data quality across the clinical trials unit.
Work closely with the clinical trial unit staff to facilitate communication and track recruitment of patients/volunteers into the trials.
Enter/correct study data for national networks.
Maintain/design data tracking systems, and analyze data trends and outcomes.
Assist with interpretation of data and preparation of regular and ad-hoc reports.
Respond to queries regarding data accuracy.
Train additional staff members to assist with data entry and QC practices for the CRU.
Provide regulatory backup for clinical research protocols, including preparation of regulatory quality assurance protocols and communication with IRBs.
Perform additional related duties as needed.
Bachelor's degree in computer/health-related field, or equivalent in education and experience, plus two years of experience
Proficiency in the use of Microsoft Word, Microsoft Access, Microsoft Excel, and REDCap
Willingness to learn the use of national data management systems
Organized and detail-oriented with the ability to prioritize and manage multiple projects
Excellent interpersonal and communication skills
Basic knowledge of viral infections (specifically HIV and SARS-CoV-2) and clinical research
Proficiency or fluency in Spanish
Working knowledge of common national data management systems including Medidata/Rave and iDataFax
Successful completion of applicable compliance and system training requirements
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 508751
About Columbia University
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.