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Kansas City Metro Area, USA
Onsite
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KMCRI-AdministrationJob Duties
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.
Ensure the protection of clinical trial participants by reviewing and verifying the informed consent process, subject eligibility and enrollment procedures, investigational product accountability, regulatory and Trial Master File documentation, and correlative laboratory collection and shipment records.
Oversee clinical trial data collection to confirm alignment with protocol-specific timepoints and requirements and maintain compliance with all applicable regulatory and institutional standards.
Confirm the validity and integrity of trial specific data submitted on Case Report Forms (CRFs) or other data collection tools by performing thorough and detailed source document review. Review data for missing or inaccurate data.
Generate detailed and concise monitoring visit reports, close-out visit reports and other documentation needed for Clinical Program Management to resolve outstanding protocol specific or institutional issues and queries.
Confirm clinical program management staff have received proper materials and instructions to enter sensitive health information and data points into CRIS/Velos CTMS.
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.
Work with Site Development, IIT Regulatory, KUCC Finance and CTO Research Project Director on multisite IIT development, onboarding, and site initiation.
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.
Provide ongoing training, mentoring, and coaching, while ensuring adherence to organizational policies and procedures, as directed by the QA Project Manager or Senior Director of Quality Assurance.
Act as a Quality Assurance resource to clients of the Clinical Trials Office, evaluate problems and provide solutions.
Identify project issues and suggest possible solutions; manage problem resolution through expedient and corrective means.
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. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Work Environment
Travel as required to conduct interim monitor visits at multi-site IITs and attend national meetings. Off-site travel is limited but could be 5% – 20%.
Required Qualifications
Work Experience:
6 years of relevant work experience. Relevant education may substitute for experience on a year for year basis.
Experience with Clinic Coordination and/or On-site/Remote Monitoring and Risk-based or Source Data Verification Monitoring.
Experience with FDA regulations relevant to drugs, devices, biologics.
Preferred Qualifications
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:
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
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. 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.
Minimum
$60,800.00Midpoint
$76,000.00Maximum
$91,200.00