University of Kansas School of Medicine

University of Kansas School of Medicine

Senior Regulatory Coordinator - Comprehensive Integrated Research Operations (CIRO)

Kansas City Metro Area · Senior · Full-time

Sponsorship not specifiedDetected 12 hours ago
GCPComplianceForecastingBudgetingHIPAAClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationTime ManagementGAAPRegulatory Affairs

About the role

  • The Senior Regulatory Coordinator is responsible for leading and performing study-specific regulatory and safety reporting for a group of investigators, within multiple cost centers in the Department of Internal Medicine.
  • It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, duties, and assignments.
  • Furthermore, job duties and responsibilities may change at any time with or without notice.

Responsibilities

  • This individual will support study-start up activities including IRB/Ancillary committee submissions, and maintenance of regulatory records throughout the life project for assigned cost centers.

Requirements

  • Experience in a environment requiring an understanding of regulations governing clinical research (CFR, GCP, HIPAA) and statutes and guidelines relevant to regulatory affairs in clinical research.
  • Required Certifications: Research certification such as:
  • Provide updates as required, escalate as appropriate.

Nice to have

  • Certified Clinical Research Coordinator (CCRC).
  • Certified Clinical Research Professional (CCRP).
  • Association of Clinical Research Professionals (ACRP).

Skills

  • Communication
  • Multitasking
  • Time management
  • Interpersonal skills
  • Computer skills
  • Required Documents
  • Cover Letter
  • Comprehensive Benefits Package:
  • Employee Type:
  • Regular Time Type:
  • Full time Rate Type:
  • Compensation Statement:

Compensation

  • $60,800.00 - $91,200.00 Minimum
  • $60,800.00 Midpoint
  • $76,000.00 Maximum
  • Compensation Statement:
  • 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.

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.
  • Master's Degree in health sciences, biology, nursing, or a related field.
  • This position is responsible for ensuring that the research is compliant with applicable federal, state, or international requirements, while adhering to policies of the University of Kansas Medical Center.

Visa & Work Authorization

  • inancial compliance and consistency with contracts/agreements over the life of the project, following institutional and sponsor guidelines

This listing is sourced directly from University of Kansas School of Medicine's careers page and normalized into a canonical job model.