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Regulatory Coordinator - Nephrology

Medicine

Regulatory Coordinator - Nephrology

  • 531630
  • Medical Center
  • Medicine
  • Full Time
  • Opening on: Dec 8 2022
  • Grade 103
  • Job Type: Officer of Administration
  • Bargaining Unit: n/a
  • Regular/Temporary: Regular
  • End Date if Temporary: n/a
  • Hours Per Week: 35
  • Salary Range: $58,500 - $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 Regulatory Coordinator will support the regulatory functions for all research protocols and will coordinate clinical trials within the Division of Nephrology. This position reports directly to the Nephrology Regulatory Manager. The work location for this position will be the Columbia University Medical Center campus.    


Responsibilities

  • Review and complete training on each research protocol.
  • Assist Principal Investigators in study start up and submit protocols and modifications to appropriate offices, including the Institutional Review Board.
  • Under the supervision of the Regulatory Manager, assist with the creation and maintenance of regulatory documentation and administrative files for each protocol.
  • Interact with study monitors and liaise with contracted institutions.
  • Work with the study team to maximize efficiency.
  • Work with treating physicians and Principal Investigators to confirm that each potential subject meets eligibility criteria for enrollment into the proposed clinical trial.
  • Maintain documentation of eligibility.
  • Coordinate study enrollment, protocol treatment, and follow-up visits for patients participating in assigned clinical trials.
  • Manage communication with study participants.
  • Schedule, conduct, and document study visits, including biospecimen collection and laboratory procedures.
  • Coordinate specimen shipments as required per protocol. 
  • Communicate with various departments, physicians, labs, outside hospitals, and all members of the clinical team to ensure accuracy, timely retrieval of data, and confirm the appropriateness and timeliness of tests and study visits.
  • Complete timely research billing review.
  • Maintain and update sponsor-related, university and department databases and logs.
  • Collect all required data and relevant clinical information for each study subject as required per protocol and maintain a Subject Source binder for each assigned patient.
  • Organize and maintain Subject Source documents in an audit-ready manner.
  • Perform data entry and query resolution using Electronic Data Capture (EDC) systems.
  • Ensures data quality and integrity, and compliance with all with all regulatory and institutional requirements.
  • Perform other related duties and participate in special projects as assigned.

Minimum Qualifications

  • Bachelor's Degree or equivalent in education and experience, plus two years related experience
  • Ability to communicate clearly and effectively with patients, coworkers, and medical staff
  • Excellent organizational, communication, and interpersonal skills
  • Attention to detail and the ability to work independently
  • Proficiency in Microsoft Office

Preferred Qualifications

  • Experience in a clinical research setting with knowledge of HIPAA and GCP
  • Phlebotomy skills
  • Bilingual in English/Spanish

Other Requirements

  • Participation in medical surveillance program
    • Contact with patients and/or human research subjects
    • Potential bloodborne pathogen exposure
  • Successful completion of applicable compliance and systems training requirements

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

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