Quality Assurance Coordinator

Position Summary

The incumbent will conduct Quality Assurance activities and training for various research studies. The incumbent will report to the PRC Program Manager and Principal Investigator as well as the Program Manager of MFMU, a federally sponsored research grant at Columbia University dealing with pregnant women and their newborns. The incumbent will provide support services for the Perinatal Research Consortium (PRC), the Maternal Fetal Medicine Unit Network (MFMU), and the Principal Investigators and Program Managers. They will serve as the quality liaison among the PRC sites for grant-funded studies, not industry-sponsored studies, and the MFMU Network satellites under Columbia University. The full-time officer will spend time as needed at each of the PRC satellite sites and MFMU satellite sites.

Responsibilities

• Review the source documents of randomly selected (usually 10% of total enrolled participants) study charts and compare to the abstracted data reported in study charts or case report forms.
• Conduct focused chart reviews on studies with a high volume of data queries and chart audits.
• Perform and assist with Data Check and Data Audit requests from the study sponsors.
• Review source documentation (electronic medical records and paper charts) for accuracy of data abstraction.
• Collect outcome data for participants enrolled and completing the studies from the participant?s chart.
• Monitor data management procedures at our study locations and make recommendations for improvement in processes.
• Develop tools for standardized research documentation to be used by research coordinators at all subsites conducting the same study.
• Develop tools for personnel training and orientation to new studies and new processes in the study networks.
• Develop materials for dissemination to staff and faculty when new study protocols are implemented to educate all coordinators and staff on the new procedures.
• Conduct new staff orientation and training to the study networks and study protocols.
• Train existing staff training new protocols as they begin at our study sites.
• Review staff certification requirements and evaluations for studies as new staff are added.
• Monitor and enforce standardized documentation of research process at satellite sites of our study networks.
• Maintain an online regulatory document system, Lab Archives, for PRC studies and MFMU studies as needed.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Requires bachelor?s degree or equivalent in education and experience, plus three years of related experience.
• Experience with quality assurance monitoring of research studies.
• Current certification as a Clinical Research Professional or In-Progress certification must be certified within 3 months.
• Excellent interpersonal communication and organizational skills.
• Must be available for flexible hours and extended travel among satellite sites.

Preferred Qualifications

• Experience in Obstetrics and Gynecology.
• Knowledge of perinatal medicine.
• Experience with randomized clinical trials
• Master?s degree in related discipline.
• Bilingual Spanish speaking.