The project manager will be the primary liaison to the PI in the management and execution of the funded federal research grant.
Responsibilities include assisting in the development of the Manual of Operating Procedures, maintaining the regulatory binder, IRB submissions and modifications, patient enrollment and consent, as well as data collection and entry. The individual will also assist in the preparation of scientific publications and presentations emanating from the grant and any correspondence with the FDA as necessary. Furthermore, they are responsible to monitor PI and Co-Investigator sites' productivity to ensure consecutive enrollment, complete data collection, and timely and accurate data entry. They will serve as liaison and reference person for research coordinators, PI, co-investigators, statisticians and the department's research administration personnel. They will visit each site during active enrollment to ensure completeness of protocol procedures. They will participate in all conference calls and lead/organize all research meetings associated with the grant. They will develop and oversee all research coordinator meetings. They will provide quarterly reports to the PI and Co-Investigators summarizing overall progress to date for all study sites. They will be responsible for the management of the study database and oversee the screening and consenting of research subjects at CUIMC. They will ensure that standards regarding subject registration, protocol specific tests, and required documentation are adhered to. The will manage and execute IRB submissions for initial approval, modifications, annual reviews, etc. They may assist in the collection and delivery of blood samples to the laboratory. They will represent the Principal Investigator in departmental and external audits when necessary. They will also be responsible for maintenance of all study related records (paper and electronic). They will oversee and coordinate with student clinical investigators. This individual reports directly to the PI and the Director of Research Support and Administration for the Department of Orthopedic Surgery.
Requires a Bachelor's degree or equivalent in education and experience, plus three years of related experience.
Knowledge of the Columbia RASCAL system and IRB regulations and compliance issues, clinical grant writing and management desired. Experience in a public health research setting is preferred. Knowledge of REDCap is also desirable. An MS degree is preferred, as well as a working knowledge of orthopedic terminology.
This position requires excellent organization skills, communication, and interpersonal skills, attention to detail and the ability to work independently. Proficiency in Windows Operating environment and MS Word and Excel required. Some proficiency in statistical analysis and a basic knowledge of SAS/SPSS is desired.
Will have contact with patients and/or research subjects.
Must successfully complete system training requirements.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 506288
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