Overview
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.
Qualifications
Minimum Qualification:
Bachelor’s degree in specific research field such as Public Health and 4 years’ experience recommended
Current certification as a Clinical Research Professional (ACRP or SOCRA) or obtained within 4 months of hire
Preferred Qualifications:
Master’s degree in specific research field such as Public Health, Biomedical Sciences including OBGYN preferred.
Clinical experience in OB/GYN and/or perinatal medicine.
Experience in Randomized Clinical Trials
Excellent communication and interpersonal skills, and confidence when speaking with study participants and clinical personnel.
The ability to abstract information from medical records for screening and data collection purposes. Must be able to gather data, perform electronic data entry, and present these data to the research team in a written report or oral format.
Excellent organizational skills and a high degree of accuracy and attention to detail with flexibility in assuming assignments, as well as the ability to work independently
Demonstrated track record of understanding research process, with attention to confidentiality, ethical issues, data security, and IRB regulations.
Ability to multi-task and to proactively identify challenges associated with a protocol to permit the implementation of innovative solutions
Hiring 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.
Equal Employment Opportunity StatementColumbia University is an Equal Opportunity Employer / Disability / Veteran
Pay Transparency Disclosure
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.
