University of Kansas School of Medicine

University of Kansas School of Medicine

Regulatory Coordinator - Cancer Center

Kansas City Metro Area · Full-time

Sponsorship not specifiedDetected 16 days ago
GCPComputer VisionComplianceExcelHIPAAClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationProblem SolvingTime ManagementMicrosoft OfficeRegulatory Affairs

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About the role

  • The Regulatory Coordinator is responsible for performing study-specific regulatory and safety reporting across multiple studies.
  • This position will be the assigned contact for study-start up activities including IRB/Ancillary committee submissions, and maintenances of regulatory records throughout the life of an assigned protocol.
  • The University of Kansas Cancer Center is the region's only National Cancer Institute-designated comprehensive cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.

Responsibilities

  • Prepare and submit all regulatory documents including to the Institutional Review Board, collaborate with team members to ensure regulatory documents are complete and accurate.
  • Maintain trial master file and/or regulatory binder.
  • Ensure coordination of area work with other areas of KUMC to ensure integration and support of KUMC goals and objectives.

Requirements

  • Work experience in an environment requiring an understanding of regulations governing clinical research (CFR, GCP, HIPAA) and statutes and guidelines relevant to regulatory affairs in clinical research.
  • Experience with Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).

Skills

  • Initiative
  • Organization
  • Detail-Oriented
  • Interpersonal
  • Multitasking
  • Communication
  • Analytical
  • Problem-solving
  • Time management
  • Required Documents
  • Cover Letter
  • Comprehensive Benefits Package:

Compensation

  • The pay range listed for this position is determined by our compensation program using market data and salary benchmarking.
  • A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding.
  • At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.

Benefits

  • Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan.
  • Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available.
  • Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays.
  • One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment.
  • A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. https://www.kumc.edu/human-resources/benefits.html
  • A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding.
  • At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
  • Four (4) years of work experience in healthcare or research setting.
  • Education may be substituted for experience on a year for year basis.
  • Maintain study files for team credentials (GCP Training, CV, Medical License).
  • Maintain confidentiality of medical center, employee, and patient information.
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