University of Kansas School of Medicine

University of Kansas School of Medicine

Clinical Site Manager - Cancer Center

Kansas City Metro Area · Full-time

Sponsorship not specifiedDetected 11 days ago
GCPProject ManagementAuditingCustomer SuccessClinical TrialsClinical ResearchFDA RegulatoryResearchMentoringInternal AuditGxP

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Entry-level history60
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Fits your clock70

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About the role

  • Conduct interim monitoring review for all investigator-initiated trials developed by KUCC and managed by the Clinical Trials Office.
  • This includes remote, risk-based monitoring (RBM) or source data verification (SDV) monitoring.
  • The Clinical Site Manager (CSM) oversees all aspects of clinical trial site monitoring, including routine monitoring visits, site close-out activities, and the maintenance of essential study documentation such as case report forms (CRFs) and regulatory files.

Responsibilities

  • Oversee clinical trial data collection to confirm alignment with protocol-specific timepoints and requirements and maintain compliance with all applicable regulatory and institutional standards.
  • Manage Investigator Initiated Trials (IIT) enrollment and registration process including randomization of study participants across all sites, providing timely study updates to all applicable site personnel.
  • Act as a primary point of contact for academic institutions participating in multisite IIT. Develop and facilitate study start up materials and training for multisite IITs.
  • Support external audit and FDA inspection readiness, as requested, by conducting comprehensive reviews of essential study-specific documentation. Participate in KUCC Quality Assurance audits, inspections, and ad hoc review activities.
  • Identify project issues and suggest possible solutions; manage problem resolution through expedient and corrective means.

Requirements

  • Experience with FDA regulations relevant to drugs, devices, biologics.
  • 6 years of relevant work experience.
  • This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
  • Travel as required to conduct interim monitor visits at multi-site IITs and attend national meetings.

Nice to have

  • Work experience:
  • Experience with SmartSheet, REDCap, and CRIS/Velos Clinical Trial Management System.
  • Experience working with Pharmaceutical and National Cancer Institute (NCI) or Investigator-Initiated oncology clinical trials.

Skills

  • Attention to detail.
  • Problem solving.
  • Multitasking.
  • Interpersonal skills.
  • Organization.
  • Communication.
  • Computer skills.
  • 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
  • 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.

Visa & Work Authorization

  • fying that all studies are conducted in compliance with Good Clinical Practice (GCP) guidelines, applicable federal and sponsor regulations, KUCC policies and procedures, and approved clinical research protocols
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