Clinical Research Manager - Infectious Diseases

• Requisition no: 525338






• Work Type: Full Time






• Location: Campus|Medical Center






• School/Department: null






• Categories: Research (Lab and Non-Lab)






• Job Type: Officer of Administration





• Regular/Temporary: Regular





• End Date if Temporary:





• Hours Per Week: 35

Position Summary

CSES Clinical Research and REDCap Manager coordinates administrative, academic and research activities in the CSES division including manuscript editing and publications, lectures and conferences, educational courses, and visitors. Is responsible for the preparation, budgeting and submission of IRB and grants and contracts protocols and oversight of the Academic Coordinators in the Department. They will also be responsible for managing and maintaining the department’s REDCap activities. This position reports to the Director of Research Administration.

Responsibilities

CSES Clinical Research (50%)

• Manages research personnel within the Center for Shoulder, Elbow and Sports Medicine (CSES) division, including other research coordinators, research assistants, students and volunteers. Provides guidance to members of the division research team in the implementation and evaluation of clinical research; trains new staff.





• Primary liaison to PI(s) in developing plans and statistical analyses for research projects and discussing the interpretation of results; collaborates in the preparation of manuscripts for publication and preparation of grant proposals to sponsoring agencies; assists in and tracks the preparation of amendments to protocols and/or modifications to study designs as appropriate. Position reports to the Director of Clinical Outcomes and the Department Director of Research Support and Administration.





• Responsible for the development of patient reported outcome measures, questionnaires, and the application of research techniques; assists in writing instructional procedure manuals for study progress, data collection and coding; reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies





• In conjunction with the PI, designs, implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies. Also identifies problems and/or inconsistencies and monitors participant's progress to include documentation and reporting of adverse events. Resolves IRB/protocol management issues and recommends corrective action as appropriate. This person serves as the liaison with funding or sponsoring agencies in conjunction with the Department Grants and Contracts Administrator and the Department Research Finance and Grants Administrator.

Department REDCap Management (50%)

• In addition to supporting the CSES division as detailed above, the incumbant is the REDCap administrator for the Department of Orthopedic Surgery and all its research divisions that utilize REDCap. Provides security oversight of the Orthopedics instance of REDCap, ensures backups of all REDCap related files and projects. Is responsible for all IRB / HIPAA compliance of all REDCap projects. Provides REDCap support and guidance to PIs and research coordinators throughout the department, which includes, but is not limited to, development of new REDCap projects and support of current REDCap projects. Serves as one of the Department’s representatives to all EPIC and REDCap related CUIMC committees.





• Evaluates and interprets collected clinical data in conjunction with PI(s) as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same. Works with the department statistician in the development of study design, power analysis and processing of study data, and is responsible for the incorporation of statistical methodology and results in division manuscripts.





• Performs other duties incidental to the work described above.

Minimum Qualifications

• Requires a bachelor’s degree or equivalent in education and experience, plus four years related experience





• Proficiency in Windows Operating environment and knowledge of computer and software applications (i.e., Microsoft Office, REDCap) required





• Strong interpersonal, as well as oral and written communication skills





• Highly organized with excellent attention to detail and follow-up skills





• Ability to work independently, as well as perform as part of a team





• Flexibility and willingness to adjust schedule to meet deadlines





• Knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects with working knowledge of database management, spreadsheet, and statistical analysis software is desired. Responsible to oversee the submission of department clinical data to national registries as required.

Preferred Qualifications

• Master’s degree desired





• Working knowledge of SQL desired





• Working knowledge of EPIC desired





• Knowledge of the Columbia ARC and RASCAL systems, as well as Assist, Grants.gov and ProposalCentral, and CRA certification





• Knowledge of Columbia IRB regulations and compliance issues, clinical grant writing and management is highly desired





• Experience in clinical research setting is preferred

Equal Opportunity Employer / Disability / Veteran

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