Quality Assurance Coordinator
3 weeks ago
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
- The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting._
Position Summary
The incumbent will conduct Quality Assurance activities and trainings for various research studies.
Reports to the Principal Investigator and Program Manager of a federally sponsored research grant at Columbia University dealing with pregnant women and their newborns. Provides support services for the Maternal Fetal Medicine Unit Network (MFMU), the Principal Investigator and Program Director in terms of quality liaison among the MFMU Network satellites under Columbia University. The full-time officer will spend time as needed at each of the 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.
- 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.
Minimum Qualifications
- 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.
Preferred Qualifications
- MD or RN.
- Experience in Obstetrics and Gynecology.
- Experience with randomized clinical trials.
We are continuously seeking to recruit individuals who will enhance the diversity of our workplace and the effectiveness of our organization.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
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