Assist the Principal Investigators and Program Director in ensuring that the complex nature of this multicenter project (ECHO-NFGS) is implemented, conducted and completed in compliance with NIH and ECHO policies and procedures such as data sharing, regulatory documentation, and reporting of human subject activities to the central IRB.
Execute a multitude of duties related to the Executive Committee and Subcommittee meetings/calls including: arrange/coordinate conference calls and videoconferences; set up agendas and assure adherence to deadlines; review, compile, and disseminate materials; set up, attend, draft and distribute minutes; participate in all committee meetings and serve as a liaison between committees to ensure the appropriate information is shared between committees; and develop, disseminate, draft and monitor completion of action items.
Serve as the central liaison for the central IRB process including submission of materials to the IRB, communicating with sites regarding amendments to study materials, facilitating the collection of local site materials as needed for the central IRB process, reporting and monitoring of serious adverse events; maintain adverse event files to ensure timely reporting activities and protection of ECHO human subjects; and all other activities required for the Central IRB Process.
Assist investigators in reviewing, editing, tracking, and coordinating all manuscripts on the ECHO-NFGS cohort and assist investigators and their staff to assure compliance with the NIH public access policy.
Ensure all relevant ECHO-NFGS documents are saved on "BOX" and on the study website
Assist the study team with Data Use Agreement and Data Transfer related activities.
Ensure the timely follow-up on requests from the Program Office, Data Coordinating Center and Clinical Coordinating Center.
Assist with e-mail triage and follow-up and other duties as assigned.
General Minimum Qualifications: Requires a bachelor's degree or equivalent in education and experience, plus four years of related experience.
Additional Specific Minimum Qualifications: The successful applicant must have demonstrated leadership abilities in the management and coordination of projects. Must possess detailed knowledge of the federal research process including the preparation of progress reports, adverse event reporting and regulatory affairs. Must demonstrate leadership ability to plan, organize and direct the activities of the research team. The position requires a motivated individual with excellent interpersonal skills and strong organizational qualities. Computer skills required--Microsoft Office including PowerPoint and Excel.
Preferred Qualifications: Experience with IRB submissions and the Central IRB process.
As a member of the National Collegiate Athletic Association (NCAA) and the Council of Ivy Group Presidents (Ivy League), it is imperative that members of the Columbia University community, in all matters related to the intercollegiate athletics program, exhibit the highest professional standards and ethical behavior with regard to adherence to NCAA, Conference, University, and Department of Intercollegiate Athletics and Physical Education rules and regulations.
Columbia University is an Equal Opportunity/Affirmative Action employer.
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It... seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.