Quality Assurance Coordinator
Columbia University
- New York
- $75,000-85,000 per year
- Temporary
- Full-time
- Job Type: Officer of Administration
- Bargaining Unit:
- Regular/Temporary: Regular
- End Date if Temporary:
- Hours Per Week: 35
- Standard Work Schedule:
- Building:
- Salary Range: $75,000 - $85,000
- 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.
- Assist with 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.
- Conduct Quality Assurance activities and responsibilities listed above for PRC studies as needed (33% effort).
- 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.
- Requires bachelor's degree or equivalent in education and experience, plus four years of related experience.
- Knowledge of perinatal medicine.
- Current certification as a Clinical Research Professional or certification in progress. Must be certified within 3 months of hire.
- Excellent interpersonal communication and organizational skills.
- Must be available for flexible hours and extended travel among satellite sites.
- MD or RN.
- Experience in Obstetrics and Gynecology.
- Experience with randomized clinical trials.