The candidate will be responsible for coordinating with Research Assistants and Tech B's to ensure study responsibilities are met. Will review new protocols, consent documents and budgets for operational and fiscal feasibility. In collaboration with the Regulatory Manager, ensures start up regulatory documents are completed, signed as appropriate and provided to the sponsor.
Coordinate multiple projects
Obtain proper informed consent, collecting data and completing case report forms appropriately
Establish internal and external, relationships with local physicians and clinical teams
Screen for potential subjects, prepare recruitment plans and revise as necessary to meet target enrollment goals
Ensure that pertinent tests, procedures, and lab work are scheduled and completed according to protocol
Interact appropriately with subjects, sponsors, monitors, data coordinating centers and core laboratory personnel as needed
Understand the clinical process, attend compliance training programs, travel to investigator meetings, and participate in site initiations
Practice GCP and FDA/HHS regulations, fulfill regulatory and reporting requirements for clinical research protocols
Comply with Columbia University and Hospital policies and procedures related to Clinical Research
Perform other responsibilities as required
Bachelor's Degree or equivalent combination of education and experience and at least two years' related experience
Strong communication and organizations skills required
Participation in Medical Surveillance Program
Must successfully complete system training requirements
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 510608
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.