The Multi-Center Trials (MCT) Clinical Research Coordinator will play an integral role in the coordination and conduct of clinical trials involving human subject research. The candidate is responsible for providing coordination of multi-center trials including regulatory management and monitoring support. The MCT Clinical Research Coordinator will work with CUIMC and affiliate site study teams to maximize work efficiency in gathering all required regulatory information and documentation.
Responsibilities include, but are not limited to:
Under the supervision of the Multi-Center Clinical Trials Manager, the coordinator will conduct regulatory monitoring on a quarterly basis for actively accruing trials in the MCT portfolio, and on an ad hoc basis for trials closed to accrual.
The coordinator will be responsible for generating reports to capture regulatory deficiencies and required follow up by the affiliate site.
Provides effective communication of all actionable regulatory findings to the affiliate site personnel and follows until appropriate resolution has been obtained.
Ensures site regulatory and IRB approval documents, including initial approval, annual renewals and required protocol amendments are maintained and tracked as appropriate within the MCT central files.
Ensures site personnel documents are maintained within the MCT central files from time of trial activation to closure, including delegation of authority logs, FDA Form 1572, CVs, medical licenses, financial disclosure forms, and human subjects/good clinical practice training.
Ensures site laboratory documents are maintained within the MCT central files from time of trial activation to closure, including CLIA/Laboratory Certifications for Local Laboratories listed on FDA 1572, Local Laboratory Directors CV and License, and Local Laboratory Reference Ranges.
Provides coordination for disseminating study materials to affiliate sites at time of initial activation and for all subsequent protocol amendments.
Ensures disseminated study related materials for required amendments are approved and implemented by the site within 90 days of receipt (e.g. amendments, study notifications, etc.) or as required per protocol.
Provides real time tracking of site regulatory submissions and approvals. Reviews site submission documents (i.e. ICF) and approval letters to confirm regulatory submissions capture all elements of the CUIMC approved protocol, ICF documents, IBs/package inserts, and subject forms (i.e. pill diaries, questionnaires, etc.) including any regulatory updates.
Will practice GCP and FDA/HSS regulations and will comply with Columbia University and Hospital policies and procedures related to Clinical Research.
Coordinator performs other related duties and participates in special projects as assigned.
Requires a Bachelor's degree or equivalent in education and experience plus 2 years of related experience
Excellent interpersonal and organizational skills
Computer Skills: Proficiency with Microsoft Word programs and familiarity with Mac and PC platforms
Experience in a clinical research setting with knowledge of HIPAA and GCP
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 503475
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.