To be considered for this position, you must apply via the link below:
Position URL: http://apply.interfolio.com/148635
Position Description
The Columbia University, Dept Of OBGYN is seeking a fulltime Staff Associate II to conduct quality assurance activities and staff trainings for multiple concurrent research projects of the Maternal Fetal Medicine Units Network and the Perinatal Research Consortium. A successful candidate will have experience in obstetric and perinatal medicine as well as research experience with randomized clinical trials and regulatory research requirements.
Monitoring Existing studies for accuracy and regulatory compliance- 30%
- 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.
- 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 and enforce standardized documentation of research process at satellite sites of our study networks.
- Knowledge of Human Subjects Research Compliance. Submit regular monitoring reports for review of study source documents and case report forms.
Resource and expert in current MFM studies and Perinatal subject matter- 25%
- Develop knowledge of the research topics involved in each project, and understand how all involved personnel’s functions inter-relate and support broader research goals.
- 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.
- Train existing staff training new protocols as they begin at our study sites.
- Semi- independent analysis of research questions requiring problem solving. Organizational skills that aid in problems solving. Analyze and solve complex problems, and exercise judgment based on interpreting multiple sources of information.
Manage data Integrity procedures including audits and data checks- 25%
- Perform and assist with Data Check and Data Audit requests from the study sponsors. Assist coordinators in answering weekly queries regarding data entry discrepancies.
- Collaborate with research team to ensure organization and consistency of data handling and archiving procedures. Maintain an online regulatory document system, Lab Archives, for PRC studies and MFMU studies as needed. Communicate study updates and changes to staff at subsites, serve as liaison between coordinators and study hubs- 15%
- Skilled communicator via written and verbal methods and for various levels of research staff. Translate information into general terms and help others understand impact of the information.
- Attend all scheduled meetings regarding ongoing and future studies for updates and protocol changes.
- Conduct Quality Assurance activities and responsibilities listed above for PRC studies as needed (33% effort PRC and 67% MFMU). Training of new staff at main and sub-sites- 5%
- Assist with new staff orientation and training to the study networks and study protocols.
- Review staff certification requirements and evaluations for studies as new staff are added.
The Department of Obstetrics and Gynecology is dedicated to the goal of building a multicultural faculty and staff committed to teaching, working and serving in a diverse community, and strongly encourages applications from candidates of traditionally underrepresented backgrounds.
We are continuously seeking to recruit individuals who will enhance the diversity of our workplace and the effectiveness of our organization.
Job Type: Full-time
Pay: $75,000.00 - $85,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Ability to Relocate:
- New York, NY: Relocate before starting work (Required)
Work Location: In person