• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $100,000 - $115,000

Position Summary

The candidate will be responsible for the oversight and quality assurance activities of industry, and NIH sponsored projects as well as investigator initiated studies within the Department of Obstetrics and Gynecology. This position requires a motivated individual with excellent interpersonal skills and strong organizational qualities who can interact with investigators, researchers and research staff members within the Department of Obstetrics and Gynecology and throughout Columbia University.  This individual must have knowledge of Obstetrics, Perinatology, Gynecology and Women’s Health as well as the process of conducting clinical research. While working under the direct supervision of the OB/GYN Director of Research Administration and Operations, the incumbent should be self-directed and capable of working independently. In addition, the Manager of Research Quality and Education will be responsible for monitoring and enforcing standardization of the research process. The incumbent will assist with research regulatory procedures namely Institutional Review Board submissions for various research studies. The incumbent may interact with human subjects and provide staff coverage as needed.

Responsibilities

• Supervising QA Monitor(s)
• Performing chart reviews on randomly selected charts
• Performing chart reviews on high volume enrollment studies, clinical trials or complex procedures
• Performing data Forms Audits
• Performing source Documentation reviews
• Collecting outcome data collection as needed
• Reviewing records of patients with queries, edits and audits identified as being problematic
• Monitoring data management procedures and make recommendations for improvement
• Create and implement monitoring plans
• Developing tools for standardized research documentation
• Serving as a research liaison between the department and the divisions
• Developing materials for dissemination to staff and faculty when new protocols are implemented
• Providing education to research staff members related to study protocol and research activity within the department including but not limited to:
• Boot Camp 1 and 2
• Quarterly Education Sessions
• Research Essentials
• Develop research education session, as needed – i.e. CAPA, etc.
• Participation in divisional and departmental research education meetings

• Developing tools for personnel training and orientation (both on-boarding and off-boarding)
• Monitoring compliance with all HIPAA, GCP, billing, safety and other research specific regulations/guidelines
• Maintain SharePoint
• Perform site visits and audit prep (i.e. visits to sub-sites, work closely with research teams to prep for sponsor, FDA and other entities audits/site visits)
• Prepare for site visits by sponsor, NIH, FDA and other entities including reviewing charts for eligibility confirmation, data quality, regulatory documents, and working closely with OBGYN research team to prep
• Review sponsor monitoring reports, develop CAPA and monitor as needed
• Review and approval of projects (Rascal new submissions, renewals and RedCap)
• Track all research projects in the Department of OBGYN
• Provide guidance to Department of OBGYN researchers about compliance with applicable federal, state, local and institutional policies and guidelines
• Responsible for providing monitoring visit follow-up reports and Quarterly Quality Assurance Reports
• Special projects as determined by department leadership
• Oversight of QA Activities in the Department of Medicine per the MOA
• Perform other related duties and responsibilities as assigned/requested

Minimum Qualifications

• Requires a Bachelor's degree or equivalent in education and experience, plus four years of related experience.
• Knowledge of OB/GYN medicine.
• Current certification as a Clinical Research Professional.
• Minimum of 10 years’ experience in sponsored research.
• Must have knowledge of Obstetrics, Perinatology, Gynecology and Women’s Health

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.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.