The Clinical Research Coordinator will report to the Principal Investigator (PI) and the research supervisor and will be responsible for subject recruitment and the conduct of clinical studies. Additional responsibilities include maintaining compliance with existing policies and procedures at Columbia University, the IRB, and the CTSA, that relate to clinical research.
The Clinical Research Coordinator will also be responsible for assisting with publications including data collection or organization for articles for publication, or presentation at conferences. In addition, the Clinical Research Coordinator will be responsible for the following:
Participation in pre-study, initiation, monitoring and close out visits
Clinical trial preparation involving the planning, assembling and instruction of the trial team, development and evaluation of patient information and informed consent forms and patient recruitment.
Submission of and adherence to Institutional Regulations and IRB protocols
Implementation of clinical trials from initiation, including assistance with the development of standard operating procedures and case report forms
Recruitment and coordination of the clinical trial participants covering informed consent, screening, and inclusion of the subjects adhering to safety and compliance issues.
Coordination and management of the clinical trial, communication with sponsor and monitors, visit coordination, sample acquisition and processing.
Reporting and documentation of protocol deviations and exemptions as well as development and implementation of corrective action plans for review by the Principal Investigator as needed
Data collection and management, collection of source documents, registration, and management of adverse events, filing and archiving, managing monitoring visits and managing queries.
Close-out of the clinical trial, contributing to manuscripts, audit preparation, trial completion, and communication with authorities.
Other responsibilities include assisting with the final study report and completing financial obligations.
Requires a bachelor's degree or equivalent in education and experience, plus two years experience.
Must successfully complete systems training requirements.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 503756
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.