The Project Coordinator will play an integral role in the initiation and conduct of clinical trials in the Center for Interventional Vascular Therapy (CIVT) of the Division of Cardiology.
Assist the Regulatory Manager with regards to maintaining regulatory documents and ensuring compliance with human subject regulations and policies.
Assist with the preparation of IRB submissions, obtain necessary documents such as FDA IDE/IND letters; obtain necessary signatures and approvals on regulatory documents needed to initiate protocols.
Provide regulatory documentation to study sponsors, assist with the consent form approval process; assist with internal audits of regulatory documents of protocols on a regular basis and maintain regulatory files.
Update spreadsheets tracking study submissions, IRB approvals, yearly review timelines, study personnel listings, consent form versions, and enrollment.
Communicate with clinical trials office, IRB and sponsors to ensure expeditious study start-up.
Initiate and monitor Joint Radiation Safety Committee and National Government Service applications.
Prepare complete IRB protocol, consent form, modification, renewal and unanticipated problem IRB submissions and communicates findings with managers and study coordinators.
Complete site qualification questionnaires, schedule site qualification and site initiation visits.
Submit and monitor approval of consent documents requiring Spanish translations
Obtain necessary signatures and approvals on regulatory documents needed at study start-up and throughout study completion
Attend various meetings regarding research and compliance.
Interact appropriately with the IRB, study physicians, Clinical Trials Office, sponsors, and clinical research organizations as needed.
Other responsibilities as assigned.
Bachelor's degree or equivalent in training, education, and/or experience plus a minimum of two years related experience in an academic setting.
Previous IRB submission and/or review experience.
Excellent organizational and planning skills.
Strong interpersonal skills with a focus on teamwork.
Effective oral and written communication skills, attention to detail and ability to meet deadlines and perform multiple tasks as required.
Training in GCP and HIPAA regulations will be required.
Must successfully complete systems training requirements.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 506262
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.