Advertised Summary Job Description: The Research Assistant will be responsible for the creation of study specific tools for source documentation when not provided by sponsor. Assists in recruitment efforts. Maintains research records including screening/enrollment log and regulatory files. Enter study visits in study manager. Schedules sponsor monitoring visits. Schedules follow up visits within windows specified by the protocol. Conducts follow up telephone calls as applicable. Abstracts data from medical records, clinic, consultation, and referral notes to study forms and record onto case report forms; maintains source documentation for all case report entries. Generates and tracks drug shipments, device shipments and supplies as needed. Collects, completes, and enters data into study specific case report forms or electronic data capture systems. Resolves data queries. Prepares for monitoring visits by ensuring research and regulatory binders are complete and accurate. In collaboration with the Regulatory Manager, maintains IRB approval documents; ensure RASCAL attached documents are correct and current, that outdated documents are archived and that all applicable staff have access to most recent recruitment materials, including the informed consent document in Spanish and English. In collaboration with the Regulatory Manager, ensures protocol events (modifications, renewal, unanticipated problems, terminations) are submitted to the IRB and approval documentation is in place. Communicates all protocol-related issues to appropriate study personnel or manager. Other responsibilities as assigned.
General Minimum Qualifications: Requires a bachelor's degree and at least 1.5 years of related experience or equivalent in education, training and experience.
The candidate selected for this position is required to undergo a drug screening test prior to a final offer of employment being made.
Additional Specific Minimum Qualifications:
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.