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Regulatory Coordinator

Posting Details

Position Information

Working Title Regulatory Coordinator
Classification Title Senior Coordinator
Position Number J0083200
Hours Per Week 40.000
Department CCC-KU Cancer Ctr-Admin.
Campus Location Kansas City Metro
Student Position
Position Summary

This position is responsible for regulatory activities in support of clinical research within the KU Cancer Center (KUCC). This will be accomplished by: assuring that cancer clinical research is compliant with applicable federal, state or international requirements, while adhering to policies of the University of Kansas Medical Center, KU Cancer Center and other entities involved in cancer research at the KUCC. Providing support for assigned protocols to include study start up activities and maintenance of regulatory records throughout the life of each assigned protocol.

Required Qualifications

Bachelor’s degree in a science or health-related field, or equivalent experience. Year for year of experience can be used to offset degree. Experience in the regulatory affairs of clinical research Excellent written and oral communication skills Working knowledge of database software and Microsoft software suite Knowledge of Medical Terminology Demonstrated ability to work independently Ability to effectively work in multi-disciplinary teams Must be detail oriented and have proven ability to multi-task

Preferred Qualifications

Four or more years of experience in regulatory affairs. Ability to manage and create databases SoCRA certified or SoCRA eligible.

Environment Office
Physical Requirements Light
Probation Status

Subject to the regulations of the State of Kansas, the Board of Regents and the University of Kansas Medical Center, I understand and agree that I may be subject to a probation period and during the probation period I serve at the pleasure of the Executive Vice Chancellor of KUMC and my employment may be ended at any time during that period.

Hiring Range
EEO Statement

KU Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disability status, or genetic information.

Job Duties

Description of Job Duty

Preparation and filing of all required regulatory documents. Maintenance of Trial Master File and/or Regulatory Binder per KUCC SOP.

Description of Job Duty

Assist Regulatory Lead during the study submission process by preparing required regulatory documents, assisting with documentation of study teams, or other associated tasks.

Description of Job Duty

Maintain regulatory records throughout the life of the trial to include: submission of all amendments, safety reports, adverse event reporting, annual renewals, etc. Provide associated updates to the study team.

Description of Job Duty

Interface with study sponsors during study conduct regarding regulatory documents or other regulatory issues, providing updates as required.

Description of Job Duty

Enter protocol information into Velos and promptly update study status.

Description of Job Duty

Provide assistance to monitors during routine monitor visits, or during audits of regulatory binder.

Description of Job Duty

Attend regularly scheduled department staff meetings.

Description of Job Duty

Provide workload reporting as required by management.

Description of Job Duty

Knowledge of the registration system with involvement in maintaining KUCC’s clinical trials in the database. Invited to attend monthly DWG meetings, attendance is optional.

Description of Job Duty

Other duties as assigned.

Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this posting?
    • KU Medical Center Website
    • KansasWorks
    • Career Builder
    • Monster
    • Indeed
    • NonProfit Connect
    • Higher Ed Jobs
    • LinkedIn
    • Facebook
    • Twitter
    • University Career Services Page
    • Print or online publication ad
    • Job/field-specific organization website
    • Referred by current/former employee
    • PracticeLink
    • Health eCareers
    • Other - please specify below
  2. * If you selected "other", please specify your referral source.

    (Open Ended Question)

Documents Needed To Apply

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter