• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $70,000-$72,000

Position Summary

Responsibilities

Responsibilities include, but are not limited to:

• Under the supervision of the Multi-Center Clinical Trials Manager, the coordinator will conduct regulatory monitoring for actively accruing trials in the MCT portfolio.
• 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 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.).
• Assists with registration and randomization requests
• Attends, prepares and participates in disease team and investigator meetings Assists in the coordination of monthly trials calls; maintains and distributes minutes as assigned
• Assists in the maintenance of multicenter study trackers
• Assists with the preparation of materials needed for submission of data safety monitoring reports
• Supports, facilitates and coordinates the daily clinical trial activities for multicenter trials
• Provides support for subsite startup processes
• Will practice GCP and FDA/HSS regulations and will comply with Columbia University and Hospital policies and procedures related to Clinical Research.

OTHER

• Coordinator performs other related duties and participates in special projects as assigned.
• Completes or contributes to a department wide process improvement project or initiative.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor's degree or equivalent in education and experience required.

Preferred Qualifications

• 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.