Parliament, Office Building, Building, Architecture, Urban, Postal Office, Grass, Plant, City, Town

Multi-Center Trials Clinical Research Coordinator

Herbert Irving Comprehensive Cancer Center

Multi-Center Trials Clinical Research Coordinator

  • 533003
  • New York
  • Herbert Irving Comprehensive Cancer Center
  • Full Time
  • Opening on: Dec 24 2022
  • Grade 103
  • Job Type: Officer of Administration
  • Bargaining Unit:
  • Regular/Temporary: Regular
  • End Date if Temporary:
  • Hours Per Week: 35
  • Salary Range: $60,000 - $65,000
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
 

Position Summary

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. This position reports directly to the Multi-Center Clinical Trials Manager.

This position is located at 400 Kelby St. Fort Lee, NJ.


Responsibilities

Responsibilities include, but are not limited to:
  • Under supervision of the Multi-Center Clinical Trials Manager, 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.
  • 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 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.
  • Practice GCP and FDA/HSS regulations and comply with Columbia University and Hospital policies and procedures related to Clinical Research.
  • Performs other related duties and participates in special projects as assigned.

Minimum Qualifications

  • Bachelor’s degree or equivalent in education and experience plus 2 years of related experience

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.

Apply Now

Alert me about jobs like this

Refer someone to this job

Not You?

Thank you