A Research Assistant is needed to assist with the clinical research protocol dictated follow-ups. He/she will interact appropriately with sponsors, data coordinating centers and core laboratory personnel as needed. The successful candidate will ensure that regulatory binders are complete and up-to date and ensure protocol events (modifications, renewal, unanticipated problems, terminations ) are submitted to the IRB with approval documentation in place. The candidate will review new protocols, consent documents, and budgets for operational and fiscal feasibility and work in collaboration with the principal investigators and research manager on all study related activities.
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Regulatory Manager, maintains IRB approval documents; ensure RASCAL attached documents are correct and current, that outdated documents are archived and that all applicable staff have access to most recent recruitment materials, including the informed consent document in Spanish and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
Performs other responsibilities as required.
Bachelorâ€™s degree and at least 1.5 years of related experience or equivalent in training, education, and experience
Must have excellent organizational skills.
The candidate selected for this position is required to undergo a drug screening test prior to a final offer of employment being made.
Participation in the medical surveillance program.
Must successfully meet systems training requirements.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 515083
About Columbia University
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.