Edtech.com's Summary

Columbia University is hiring a Manager, Research Quality and Education. This role oversees quality assurance for NIH and industry-sponsored projects within the Department of Obstetrics and Gynecology, ensuring compliance and standardization of research processes. The manager also interacts with investigators, monitors regulatory procedures, and provides education and support to research staff.

Highlights

Supervise quality assurance monitors and perform chart and data audits for clinical trials and complex procedures.
Develop and implement monitoring plans and standardized research documentation tools.
Serve as a liaison between departmental research teams and divisions.
Provide education and training sessions for research staff on protocols and research activities.
Ensure compliance with HIPAA, GCP, billing, safety, and regulatory guidelines.
Maintain SharePoint and prepare for sponsor, NIH, FDA, and other entity audits and site visits.
Review sponsor monitoring reports, develop corrective actions, and track all research projects within the department.
Requires knowledge of OB/GYN medicine, clinical research processes, and current certification as a Clinical Research Professional.
Must have a Bachelor’s degree plus four years related experience, and a minimum of 10 years in sponsored research.
Salary range is $100,000 - $115,000 annually.

Manager, Research Quality and Education Full Description

Salary Range: $100,000 - $115,000

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 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.

Original Job Description

Salary Range: $100,000 - $115,000

Position Summary

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

Equal Opportunity Employer / Disability / Veteran

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

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Manager, Research Quality and Education

Edtech.com's Summary

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